Bioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts

Bioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Bioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts Arthur Mapemphero Chiwaya, Shima M Abdulgader, Patricia Manjate, and 14 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8161424/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Feb, 2026 Read the published version in Clinica Chimica Acta → Version 1 posted You are reading this latest preprint version Abstract Background: C-reactive protein (CRP) is recommended to screen people living with HIV (PLWH) for tuberculosis (TB). LumiraDxis a portable platform that uses fingerprick blood. How CRP compares in fingerprick blood and serum is unknown. Methods: CRP was measured in 1034 consecutively recruited contacts of people with TB using fresh fingerprick blood (LumiraDx at point-of-care) and stored (-80°C) serum [LumiraDx and cobas C‑Reactive Protein (Latex) High Sensitive (CRPHS) in laboratories]. Agreement was assessed using Lin's concordance correlation coefficient (CCC), Passing-Bablok (PB) regression, and Bland-Altman (BA) plots. Sensitivity and specificity for TB were evaluated in 156 contacts with microbiological reference standard information. Results: Strong agreement [CCC=0.85, PB slope -0.27 (95% confidence interval -0.82, 0.2), BA mean difference 1 (-1, 3)] was observed between LumiraDx on fingerprick blood and serum. Similar agreement occurred for serum CRPHS vs. LumiraDx on serum [0.79; 1.1 (-1.1, 2.3); 11 (9, 14)] or fingerprick blood [0.75; 1.3 (-0.6, 2.5); 10 (8, 13)]. Areas under the receiver operating characteristic curves (AUROCs)were 0.747 (0.595, 0.899) for fingerprick LumiraDx, 0.761 (0.628, 0.893) for serum LumiraDx and 0.775 (0.636, 0.914) for serum CRPHS. At >5 mg/L, all tests showed identical sensitivity [77%(70, 83)]. Specificities were 60% (53, 68), 64% (57, 72) and 50% (43, 58), respectively. Serum storage duration did not affect performance. Conclusions: LumiraDx CRP readouts on fingerprick blood and serum correlate closely. Stored serum can be used for LumiraDx CRP measurement. High sensitivity methods increase the proportion of people who screen false-positive. Funding: This project is part of the EDCTP2 programme supported by the European Union and received funding under grant agreement number RIA2018D-2509. C-reactive protein bioequivalence tuberculosis contacts LumiraDx Figures Figure 1 Figure 2 Figure 3 Introduction C-reactive protein (CRP), an acute phase reactant, is elevated in infectious conditions including tuberculosis (TB) (1, 2). In 2021, the World Health Organization (WHO) recommended CRP for screening for TB amongst adolescents and adults living with HIV (PLWH) (3, 4) as it outperforms the WHO-recommended four-symptom screen (W4SS) (5-7). CRP can be measured at point-of-care on fingerprick blood (6, 8), but this may not be feasible or preferred in some settings (if, for example, serum is already collected for tests like HIV viral load). The LumiraDx platform (LumiraDx, London, United Kingdom), which can be used for multiple biomarkers, was widely deployed during the COVID-19 pandemic and is an integrated portable battery-powered point-of-care solution (9, 10). The LumiraDx CRP test is recommended for use on fingerprick blood and plasma from blood stored in heparin (11-13) (11-13). However, data on serum compared to fingerprick blood is lacking. If the platform has more use cases, it will help better utilise capacity installed during COVID-19. We investigated whether LumiraDx CRP on serum performs similarly to fingerprick blood and compared both to a laboratory-based high sensitivity method [cobas C‑Reactive Protein (Latex) High Sensitive (CRPHS); Roche Diagnostics International AG, Rotkreuz, Switzerland]. We also assessed the diagnostic accuracy of fingerprick and serum CRP against a microbiological reference standard for TB. Methods Ethics statement The study is registered on ClinicalTrials.gov (NCT04825327) and approved by the CISM Bioethics Committee (CIBS-CISM/032/21), the Mozambique National Bioethics Committee (390/CNBS/21), the Makerere University School of Biomedical Sciences REC (SBS-863) and the Uganda National Council for Science and Technology (HS1242ES), the Stellenbosch University Faculty of Health Sciences REC (N14/10/136) and the City of Cape Town (6470). Study population The PreFIT (PREdicting the Future: Incipient Tb) study recruited TB contacts to identify biomarkers predictive of incident TB (14). TB index cases were asked to refer contacts ≥12 years who did not currently have TB and were not receiving any TB treatment (nor had received treatment within the preceding two months). All participants provided a written informed consent and with parental or guardian consent for those aged 12-17 years. Participant demographic, clinical, and laboratory data, were captured on REDCap (15). LumiraDx CRP Testing was performed prospectively by trained health workers at point-of-care in primary care clinics using fingerprick blood per manufacturer's instructions. (13). If the initial result was unsuccessful (no value reported), the test was repeated once on blood from a new fingerprick. Participants with successfully generated fingerprick results and paired serum available by 31 June 2023 were selected for further analysis. Biobanked serum was then tested retrospectively by a technician in a laboratory using LumiraDx ( Supplementary Figure 1 ). Roche cobas CRP The remaining serum from the aliquot used for LumiraDx was refrozen at -80°C and shipped to the National Health Laboratory Service (NHLS), Tygerberg, Cape Town, South Africa for serum CRPHS testing (16). For all testing, staff who performed one type of test were blinded to other results (CRP, microbiology). Definitions A positive CRP result was defined using two cutoffs: >5 mg/L per WHO guidelines for TB screening (17) and >10 mg/L per the parent PreFIT study protocol (14). Diagnostic accuracy was assessed in participants who provided sputum (n=156) using a microbiological reference standard (MRS). MRS-positives were MGIT960 culture-positive (with MTBC confirmation) or Ultra-positive. MRS-negatives were negative for culture, Ultra, or both. Statistical analysis We followed the Clinical and Laboratory Standards Institute (CLSI) guidelines EP09c (18) and the Standards for Reporting of Diagnostic Accuracy Studies 2015 (STARD; checklist in supplement) (19). Sensitivity and specificity were calculated using 2×2 tables (20). Statistical tests included Kruskal-Wallis, Fisher’s exact and McNemar’s chi squared. Analyses were performed in Stata (v18; StataCorp, College Station, USA). Analysis of test agreement Pairwise agreement between fingerprick LumiraDx, serum LumiraDx, and serum CRPHS was examined using Lin’s concordance correlation coefficient (CCC), Passing–Bablok (PB) regression, and Bland–Altman (BA) analysis. CCC quantified overall concordance, with values closer to one reflecting stronger agreement. PB regression assessed systematic differences between methods, with no proportional bias if 95% confidence interval (CI) of the slope spans one, and no constant bias if the 95% CI of the intercept spans zero. The cumulative sum control chart (CUSUM) test assessed linearity assumption of PB regression, where p>0.05 indicates no evidence of non-linearity. BA analysis assessed agreement between paired measurements, providing mean bias and 95% limits of agreement [LoA; mean bias ± 1.96 standard deviations (SD)], with points above or below the regression line indicating over- or underestimation relative to the other method (21-26). For PB and BA, only values within limits of quantification were included (n=168) to prevent distortion of agreement estimates (8, 27). And the n exceeds the recommended minimum of 40 for method comparison studies. Results Participant characteristics Of the 1036 people with a prospective LumiraDx result and stored serum, 1034 had this serum successfully tested with LumiraDx. All of these were successfully tested with CRPHS. Among these participants, 63% (651/1034) were female, 85% (884/1034) HIV-negative and the median [interquartile range (IQR)] age 29 years (19-44; Table 1 ). 15% (156/1034) met the criteria for sputum microbiology, 11% (17/156) of which had TB. CRP results The proportion of fingerprick LumiraDx, serum LumiraDx, and serum CRPHS values below LODs were 64% (657/1034), 81% (842/1034), and 5% (55/1034), respectively ( Table 1 ). In people with CRP above the LOD, mean±standard deviation (SD) concentrations were 19.1±40.1, 23.3±35.4, and 8.2±19.1 mg/L, respectively and 8.5±25.5, 6.4±17.2 and 7.8±18.7 mg/L when imputed values below LODs were included. Compared with LumiraDx, serum CRPHS classified a higher proportion of participants as having elevated CRP (>5 mg/L) [31% (318/1034) vs. 19% (199/1034) for fingerprick LumiraDx, p<0.001; 31% (318/1034) vs. 18% (190/1034) for serum LumiraDx, p<0.001 ( Table 2 )]. Comparisons across tests and samples Fingerprick and serum LumiraDx had the strongest concordance with CCC of 0.85, a PB slope of -0.27 (95% CI -0.82, 0.20), PB intercept of 1.1 (1.0, 1.1), and BA mean differences of +1 (-1, 3) with LoA -25 to +27 ( Figures 1-2, Supplementary Table 1 ). Serum LumiraDx and serum CRPHS showed moderate concordance (CCC of 0.79), with PB regression indicating a slight underestimation by serum LumiraDx [slope 1.1 (-1.1, 2.3), intercept 1.4 (1.3, 1.6)], and BA analysis showing a mean difference of +11 (9, 14), with LoA from -20 to +43. Fingerprick LumiraDx and serum CRPHS showed lowest concordance (CCC of 0.75), with PB regression indicating underestimation by Fingerprick LumiraDx [slope 1.3 (-0.6, 2.5), intercept 1.4 (1.3, 1.5)], and BA analysis showing a mean difference of +10 (8, 13), with LoA from -27 to +48. No deviations from linearity were observed (CUSUM linearity p=0.15 for fingerprick LumiraDx vs. serum; p>0.20 for each LumiraDx comparisons with serum CRPHS). Diagnostic accuracy of CRP for TB AUROCs were 0.747 (95% CI 0.595, 0.899) for fingerprick LumiraDx, 0.761 (0.628 ,0.893) for serum LumiraDx and 0.775 (0.636, 0.914) for serum CRPHS. At >5 mg/l, sensitivities were similar: 77% (70, 83) for fingerprick LumiraDx, serum LumiraDx, and serum CRPHS ( Table 3 ). However, serum CRPHS had a lower specificity 50% (43, 58), compared to fingerprick LumiraDx [60% (53, 68); p=0.002], and serum LumiraDx [64% (57, 72); p10 mg/l was used. Specimen freezing duration No significant slope [R=0.014 (-0.029, 0.059); p=0.128] was observed when readouts from fingerprick and serum LumiraDx were compared as function of the duration of serum storage ( Figure 3 ). Discussion We investigated if CRP can be accurately measured on LumiraDx using serum in addition to fingerprick blood. Our key findings are: 1) fingerprick and serum LumiraDx values showed strong agreement with similar AUROCs and sensitivities for TB and 2) LumiraDx (fingerprick or serum) tended to read slightly lower than serum CRPHS with CRPHS’s higher analytical sensitivity translating into reduced specificity for TB compared to LumiraDx (sensitivities were similar). Lastly, 3) there was no relationship between serum storage duration and LumiraDx performance. Together, these data suggest serum is a reliable alternative to testing of fingerprick blood using LumiraDx. To our knowledge, this is the first study to do serological LumiraDx CRP testing. We also compared serum readouts to those from fingerprick blood and included a highly sensitive laboratory-based test as a reference. Minimal proportional and small constant bias were observed, with fingerprick LumiraDx values slightly higher than serum, possibly due to storage or freeze-thaw. However, concordance and the modest BA mean difference suggest these methods are small enough to remain within clinically acceptable limits (21-23, 26), as illustrated by the similar AUROCs and diagnostic accuracy estimates, like those described else for CRP to diagnose TB (3, 28, 29). When comparing serum CRPHS with fingerprick and serum LumiraDx, no significant proportional bias was observed, though LumiraDx tended to slightly underestimate CRP. Moreover, fingerprick and serum LumiraDx CRP each showed a similar trend compared with serum CRPHS, indicating that most variation arises from differences between testing platforms rather than specimen type or study design (prospective versus retrospective testing of thawed samples. All tests and sample types showed consistent sensitivities at >5 mg/L and >10 mg/L cutoffs. Serum CRPHS demonstrated lower specificity than fingerprick and serum LumiraDx, while specificities for the two LumiraDx methods were similar. This is likely due to its high analytical sensitivity that leads to more people without TB classified as “false-positive”, potentially due elevated yet relatively low levels of CRP associated with other causes of inflammation. More generally this finding suggests estimates of CRP performance may slightly overestimate specificity relative to symptoms if they used platforms with lower analytical sensitivity (3, 30, 31). Future meta-analyses should explore if test platform is associated with heterogeneity in diagnostic accuracy. Lastly, the duration that serum was frozen for did not affect fingerprick and serum LumiraDx performances. This aligns with studies demonstrating long-term stability of serum CRP over 4-14 years (32-34), and supports its retrospective measurement in studies (8). A key strength of this study is the large size from three countries, each with a high TB and HIV burden, and, through the availability of microbiological reference standard for TB in a subset of people, the ability to assess whether the types of bias observed are clinically meaningful. Furthermore, to our knowledge, no studies have also evaluated point-of-care CRP testing in household contacts, a group with high TB risk. Limitations include a lack of technical replicates, which would have allowed a clearer distinction between systematic bias and normal analytical variation. In conclusion, our results demonstrate strong agreement between fingerprick and serum LumiraDx CRP measurements, with minimal clinically meaningful differences and comparable TB diagnostic performance. Importantly, serum storage duration had no impact on LumiraDx performance, supporting the practical use of serum testing when fingerprick sampling is not feasible. Lastly, estimates of CRP’s specificity for TB may be slightly overestimated if most data are from non-laboratory-based methods with high analytical sensitivity. Declarations Author contributions AC, SA, VL, APN, AK, WS, ALG, FC, and GT conceived and designed the study. APN, AK, MJ, WS, ALG, FC, GT acquired funding. AC, SA, PM, JS, DN, DM, AK, WS, ALG, GT coordinated patient recruitment activities. AC, SA, PM, JS, BM, DN, DM, MB and LN assisted with laboratory analysis and data curation. AC analysed the data. AC, SA, GT wrote the manuscript with input from all authors. All authors critiqued analyses and revised the manuscript. GT and AC had full access to all study data and final responsibility for the decision to submit for publication. Declaration of interests We received in-kind donations from LumiraDx. LumiraDx had no role in study design, analysis, or results interpretation. The authors have no financial involvement with any organisation or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript apart from those disclosed. Funding This project is part of the EDCTP2 programme supported by the European Union and received funding under grant agreement number RIA2018D-2509. Acknowledgements The authors thank the study participants, and clinical teams for their contributions. 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Clin Biochem 47(4–5):315–318 Ishikawa S, Kayaba K, Gotoh T, Nakamura Y, Kario K, Ito Y et al (2007) Comparison of C-reactive protein levels between serum and plasma samples on long-term frozen storage after a 13.8 year interval: the JMS Cohort Study. J Epidemiol 17(4):120–124 van Waateringe RP, Muller Kobold AC, van Vliet-Ostaptchouk JV, van der Klauw MM, Koerts J, Anton G et al (2017) Influence of Storage and Inter-and Intra-Assay Variability on the Measurement of Inflammatory Biomarkers in Population-Based Biobanking. Biopreserv Biobank 15(6):512–518 Tables Table 1 Participants demographic and clinical characteristics stratified by site together with CRP results. CRP levels were higher in South African participants, consistent with the proportion of TB-positives. Data are n/N (%) or mean ± SD unless otherwise specified. Overall n = 1034 Mozambique 352/1034 ( 34 ) Uganda 305/1034 ( 30 ) South Africa 377/1034 (36) Demographics Age Median years (IQR) 29 (19–44) 25 (16–46) 26 (18–40) 34 (22–46) Female 651/1034 (63) 248/352 (71) 182/305 (60) 221/377 (59) HIV-positive 150/1034 ( 15 ) 70/352 ( 20 ) 23/305 ( 8 ) 57/377 ( 15 ) Microbiology testing Eligible for sputum microbiology 156/1034 ( 15 ) 35/1034 ( 3 ) 11/1034 ( 1 ) 110/1034 ( 10 ) TB-positive per MRS 17/156 ( 11 ) 0/35 (0) 2/11 ( 18 ) 15/110 ( 14 ) CRP Fingerprick LumiraDx (mg/L) 8.5 ± 25.5 5.2 ± 19.4 5.8 ± 16.7 13.9 ± 34.0 p < 0.001* Proportion below LOD 657/1034 (64) 309/352 (88) 201/305 (66) 147/377 (39) In those above LOD 19.1 ± 40.1 24.7 ± 51.9 12.1 ± 27.6 21.1 ± 42.0 Serum LumiraDx (mg/L) 6.4 ± 17.2 5.3 ± 19.4 3.8 ± 6.3 9.5 ± 20.5 p < 0.001* p < 0.001 † p = 0.359 † p = 0.022 † p = 0.004 † Proportion below LOD 842/1034 (81) 301/352 (86) 280/305 (92) 261/377 (69) p < 0.001 † p = 0.375 † p < 0.001 † p < 0.001 † In those above LOD 23.3 ± 35.4 21.9 ± 47.9 17.8 ± 16.5 25.1 ± 31.8 p = 0.211 † p = 0.790 † p = 0.324 † p = 0.369 † Serum CRPHS (mg/L) 7.8 ± 18.7 4.6 ± 12.0 4.8 ± 12.7 13.1 ± 25.5 p < 0.001* p = 0.282 † p = 0.569 † p = 0.290 † p = 0.627 † p = 0.001 ‡ p = 0.503 ‡ p = 0.024 ‡ p < 0.001 ‡ Proportion below LOD 55/1034 ( 5 ) 22/352 ( 6 ) 27/305 ( 9 ) 6/377 ( 2 ) p < 0.001 † p < 0.001 † p < 0.001 † p < 0.001 † p < 0.001 ‡ p < 0.001 ‡ p < 0.001 ‡ p < 0.001 ‡ In those above LOD 8.2 ± 19.1 4.9 ± 12.4 5.2 ± 13.2 13.3 ± 25.6 p < 0.001 † p < 0.001 † p = 0.001 † p = 0.005 † p < 0.001 ‡ p < 0.001 ‡ p < 0.001 ‡ p < 0.001 ‡ Within row p-values: * differences across sites (ANOVA). Within column p-values: † vs. fingerprick LumiraDx, ‡ vs. serum LumiraDx. Abbreviations: SD, standard deviation; IQR, interquartile range; MRS, microbiological reference standard; LOD, limit of detection; CRPHS, cobas C‑Reactive Protein (Latex) High Sensitive. Bold represents p-values ≤ 0.05. Table 2 Distribution of CRP values by assay in all participants and those with microbiological testing. Serum CRPHS classified a higher proportion of participants as having elevated CRP (> 5 mg/L) than both fingerprick and serum LumiraDx. Data are n/N (%). All participants (N = 1034) Participants with microbiological testing (N = 156) CRP range (mg/L) ≤ 5 > 5 to ≤ 10 > 10 ≤ 5 > 5 to ≤ 10 > 10 Fingerprick LumiraDx 835/1034 (81) 80/1034 ( 8 ) 119/1034 ( 11 ) 88/156 (56) 17/156 ( 11 ) 51/156 ( 33 ) Serum LumiraDx 844/1034 (82) 85/1034 ( 8 ) 105/1034 ( 10 ) 93/156 (60) 17/156 ( 11 ) 46/156 ( 29 ) p = 0.613 † p = 0.685 † p = 0.322 † p = 0.566 † p > 0.999 † p = 0.541 † Serum CRPHS 716/1034 (69) 132/1034 ( 13 ) 186/1034 ( 18 ) 74/156 (47) 17/156 ( 11 ) 65/156 (42) p < 0.001 † p < 0.001 † p 0.999 † p = 0.101 † p < 0.001 ‡ p = 0.001 ‡ p 0.999 ‡ p = 0.025 ‡ Within column p-values: † vs. fingerprick LumiraDx, ‡ vs. serum LumiraDx Table 3 Diagnostic accuracy of CRP at different positivity cut-offs for TB detection among contacts who had sputum microbiology (n = 156). Sensitivity was similar across all tests and cut-offs. Serum CRPHS showed lower specificity than fingerprick or serum LumiraDx, and specificity was higher at the > 10 mg/L cutoff compared with > 5 mg/L. Data are % (95% CI). > 5 mg/L > 10 mg/L Sensitivity Specificity Sensitivity Specificity Fingerprick LumiraDx AUROC = 0.747 (0.595, 0.899) 77 (70, 83) 60 (53, 68) 71 (63, 78) 72 (65, 79) p = 0.317* p < 0.001* Serum LumiraDx AUROC = 0.761 (0.628 ,0.893) 77 (70, 83) 64 (57, 72) 59 (51, 67) 74 (67, 81) p = 0.083* p 0.999 † p = 0.166 † p = 0.157 † p = 0.317 † Serum CRPHS AUROC = 0.775 (0.636, 0.914) 77 (70, 83) 50 (43, 58) 77 (70, 83) 63 (55, 70) p > 0.999* p 0.999 † p = 0.002 † p = 0.317 † p = 0.002 † p > 0.999 ‡ p < 0.001 ‡ p = 0.083 ‡ p < 0.001 ‡ Within row p-values: * 5 vs. 10 mg/L Within column p-values: † vs. fingerprick LumiraDx; ‡ vs. serum LumiraDx Abbreviations: AUROC, area under the receiver operating characteristic curve; CRPHS, cobas C‑Reactive Protein (Latex) High Sensitive. Bold represents p-values ≤ 0.05. Additional Declarations The authors declare potential competing interests as follows: We received in-kind donations from LumiraDx. LumiraDx had no role in study design, analysis, or results interpretation. The authors have no financial involvement with any organisation or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript apart from those disclosed. Supplementary Files LumirafingerprickCRPvs.serumsupplement.docx Supplemtentary Cite Share Download PDF Status: Published Journal Publication published 01 Feb, 2026 Read the published version in Clinica Chimica Acta → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8161424","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":548087067,"identity":"1ad9f278-ee66-4fad-a54e-820df71c13dc","order_by":0,"name":"Arthur Mapemphero Chiwaya","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0UlEQVRIiWNgGAWjYFACHoYDIIofRCQUkKJFsgGkxYBILWBgANZIjBb+9rMHD/PUHJY3Pr868cMDAwZ5frED+LVInMlLOMxz7LDhthtvN0sAHWY4c3YCAWtu8BgczmE7zLjtxtkNIC0JBrcJaJEHa/l32H7zjLObfxClxQCkJbftcOIG/t5txNlieCbH4PDfvvTkGTd4t1kkGEgQ9ovc8TPGH2d8s7bt7z+7+eaPCht5fmkCWqCgGRh2YJUSRCkHgTpgDB0gWvUoGAWjYBSMMAAAJVVKNNDyL/IAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0003-0357-9663","institution":"DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa","correspondingAuthor":true,"prefix":"","firstName":"Arthur","middleName":"Mapemphero","lastName":"Chiwaya","suffix":""},{"id":548087068,"identity":"6feafa5f-87ca-4370-b078-1746032a81f2","order_by":1,"name":"Shima M Abdulgader","email":"","orcid":"","institution":"DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa","correspondingAuthor":false,"prefix":"","firstName":"Shima","middleName":"M","lastName":"Abdulgader","suffix":""},{"id":548087069,"identity":"db280945-e1a4-4086-a4d3-fb6aba5a72c9","order_by":2,"name":"Patricia Manjate","email":"","orcid":"","institution":"Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Moçambique","correspondingAuthor":false,"prefix":"","firstName":"Patricia","middleName":"","lastName":"Manjate","suffix":""},{"id":548087070,"identity":"f1106440-bab8-486c-92e1-63740b42af82","order_by":3,"name":"James Sserubiri","email":"","orcid":"","institution":"Mycobacteriology Research Unit, Department of Medical Microbiology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda.","correspondingAuthor":false,"prefix":"","firstName":"James","middleName":"","lastName":"Sserubiri","suffix":""},{"id":548087071,"identity":"a569ba3f-85a7-4434-a53a-d7ad544a5ba9","order_by":4,"name":"Bayanda Mdoda","email":"","orcid":"","institution":"DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; 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04:25:02","extension":"html","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":119987,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8161424/v1/8989f2db467f4adc2746f5fb.html"},{"id":96454407,"identity":"4362a189-bff8-4b51-b563-68bf143327e3","added_by":"auto","created_at":"2025-11-21 10:02:42","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1381241,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePassing-Bablok regression analyses illustrating the relationship between quantitative measurements across different test and specimen combinations.\u003c/strong\u003eA) Fingerprick and serum LumiraDx; B) serum CRPHS and serum LumiraDx; C) serum CRPHS and fingerprick LumiraDx. The regression line is the solid line, and dashed lines indicate the regression confidence interval. Fingerprick and serum LumiraDx show strong agreement with similar slopes and minimal bias. Both methods demonstrate similar performance against CRPHS. Abbreviations: CRP, C-Reactive Protein; CUSUM, cumulative sum control chart; CCC, concordance correlation coefficient; CRPHS, cobas C‑Reactive Protein (Latex) High Sensitive.\u003c/p\u003e","description":"","filename":"image1.png","url":"https://assets-eu.researchsquare.com/files/rs-8161424/v1/26c9a1d743f83a0ec292571c.png"},{"id":96454090,"identity":"e3fc02ee-5475-41ae-b1e1-f09eb571945f","added_by":"auto","created_at":"2025-11-21 10:02:19","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1425957,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eBland-Altman plots evaluating agreement between the three test–specimen pairings.\u003c/strong\u003eA) fingerprick and serum LumiraDx; B) serum CRPHS and serum LumiraDx; C) serum CRPHS and fingerprick LumiraDx. The X-axes depict the mean CRP values for each pair of measurements. Y-axes depict relative differences between results of the tests on x-axes. The horizontal grey dashed line represents mean difference (bias) while the grey solid lines represent 95% limits of agreement. Fingerprick and serum LumiraDx measurements showed minimal bias. When compared with serum CRPHS, both fingerprick and serum LumiraDx tended to yield slightly lower values. Abbreviations: LoA, Limit of agreement; CRPHS, cobas C‑Reactive Protein (Latex) High Sensitive.\u003c/p\u003e","description":"","filename":"image2.png","url":"https://assets-eu.researchsquare.com/files/rs-8161424/v1/57b23e5cddfd26e2492b4154.png"},{"id":96432535,"identity":"09a0cf01-92ef-49ab-9e49-f73efb3fc0ce","added_by":"auto","created_at":"2025-11-21 04:25:02","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":384880,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFingerprick LumiraDx and serum LumiraDx differences plotted against serum freezing duration.\u003c/strong\u003e Differences in CRP values were not impacted by duration, evidenced by the lack of slope. Abbreviations:R, Pearson correlation coefficient; P, p-value.\u003c/p\u003e","description":"","filename":"image3.png","url":"https://assets-eu.researchsquare.com/files/rs-8161424/v1/e5e6b17e24ff5e9ea2632ae5.png"},{"id":101685113,"identity":"fa74761a-4e9b-4d76-9b18-49138cb7b907","added_by":"auto","created_at":"2026-02-02 15:12:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4168196,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8161424/v1/ad1da513-13ae-4633-acd0-4ebbc6968b6e.pdf"},{"id":96432533,"identity":"38c45e78-ff1a-4623-b365-9a02149737bc","added_by":"auto","created_at":"2025-11-21 04:25:02","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":85340,"visible":true,"origin":"","legend":"\u003cp\u003eSupplemtentary\u0026nbsp;\u003c/p\u003e","description":"","filename":"LumirafingerprickCRPvs.serumsupplement.docx","url":"https://assets-eu.researchsquare.com/files/rs-8161424/v1/031f0018fe15db57c4379de4.docx"}],"financialInterests":"The authors declare potential competing interests as follows: We received in-kind donations from LumiraDx. LumiraDx had no role in study design, analysis, or results interpretation. The authors have no financial involvement with any organisation or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript apart from those disclosed.","formattedTitle":"\u003cp\u003eBioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eC-reactive protein (CRP), an acute phase reactant, is elevated in infectious conditions including tuberculosis (TB) (1, 2). In 2021, the World Health Organization (WHO) recommended CRP for screening for TB amongst adolescents and adults living with HIV (PLWH) (3, 4) as it outperforms the WHO-recommended four-symptom screen (W4SS) (5-7). CRP can be measured at point-of-care on fingerprick blood (6, 8), but this may not be feasible or preferred in some settings (if, for example, serum is already collected for tests like HIV viral load).\u003c/p\u003e\n\u003cp\u003eThe LumiraDx platform (LumiraDx, London, United Kingdom), which can be used for multiple biomarkers, was widely deployed during the COVID-19 pandemic and is an integrated portable battery-powered point-of-care solution (9, 10). The LumiraDx CRP test is recommended for use on fingerprick blood and plasma from blood stored in heparin (11-13) (11-13). However, data on serum compared to fingerprick blood is lacking. If the platform has more use cases, it will help better utilise capacity installed during COVID-19.\u003c/p\u003e\n\u003cp\u003eWe investigated whether LumiraDx CRP on serum performs similarly to fingerprick blood and compared both to a laboratory-based high sensitivity method [cobas C‑Reactive Protein (Latex) High Sensitive (CRPHS); Roche Diagnostics International AG, Rotkreuz, Switzerland]. We also assessed the diagnostic accuracy of fingerprick and serum CRP against a microbiological reference standard for TB.\u003c/p\u003e"},{"header":"Methods","content":"\u003ch2\u003eEthics statement\u003c/h2\u003e\n\u003cp\u003eThe study is registered on ClinicalTrials.gov (NCT04825327) and approved by the CISM Bioethics Committee (CIBS-CISM/032/21), the Mozambique National Bioethics Committee (390/CNBS/21), the Makerere University School of Biomedical Sciences REC (SBS-863) and the Uganda National Council for Science and Technology (HS1242ES), the Stellenbosch University Faculty of Health Sciences REC (N14/10/136) and the City of Cape Town (6470).\u003c/p\u003e\n\u003ch2\u003eStudy population\u003c/h2\u003e\n\u003cp\u003eThe PreFIT (PREdicting the Future: Incipient Tb) study recruited TB contacts to identify biomarkers predictive of incident TB (14). TB index cases were asked to refer contacts \u0026ge;12 years who did not currently have TB and were not receiving any TB treatment (nor had received treatment within the preceding two months). All participants provided a written informed consent and with parental or guardian consent for those aged 12-17 years. Participant demographic, clinical, and laboratory data, were captured on REDCap (15).\u003c/p\u003e\n\u003ch2\u003eLumiraDx\u0026nbsp;CRP\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eTesting was performed prospectively by trained health workers at point-of-care in primary care clinics using fingerprick blood per manufacturer\u0026apos;s instructions. (13). If the initial result was unsuccessful (no value reported), the test was repeated once on blood from a new fingerprick. Participants with successfully generated fingerprick results and paired serum available by 31 June 2023 were selected for further analysis. Biobanked serum was then tested retrospectively by a technician in a laboratory using LumiraDx (\u003cstrong\u003eSupplementary\u003c/strong\u003e \u003cstrong\u003eFigure 1\u003c/strong\u003e).\u003c/p\u003e\n\u003ch2\u003eRoche cobas\u0026nbsp;CRP\u003c/h2\u003e\n\u003cp\u003eThe remaining serum from the aliquot used for LumiraDx was refrozen at -80\u0026deg;C and shipped to the National Health Laboratory Service (NHLS), Tygerberg, Cape Town, South Africa for serum CRPHS testing (16). For all testing, staff who performed one type of test were blinded to other results (CRP, microbiology).\u003c/p\u003e\n\u003ch2\u003eDefinitions\u003c/h2\u003e\n\u003cp\u003eA positive CRP result was defined using two cutoffs: \u0026gt;5 mg/L per WHO guidelines for TB screening (17) and \u0026gt;10 mg/L per the parent PreFIT study protocol (14). Diagnostic accuracy was assessed in participants who provided sputum (n=156) using a microbiological reference standard (MRS). MRS-positives were MGIT960 culture-positive (with MTBC confirmation) or Ultra-positive. MRS-negatives were negative for culture, Ultra, or both.\u003c/p\u003e\n\u003ch2\u003eStatistical analysis\u003c/h2\u003e\n\u003cp\u003eWe followed the Clinical and Laboratory Standards Institute (CLSI) guidelines EP09c (18) and the Standards for Reporting of Diagnostic Accuracy Studies 2015 (STARD; checklist in supplement) (19). Sensitivity and specificity were calculated using 2\u0026times;2 tables (20). Statistical tests included Kruskal-Wallis, Fisher\u0026rsquo;s exact and McNemar\u0026rsquo;s chi squared. Analyses were performed in Stata (v18; StataCorp, College Station, USA).\u003c/p\u003e\n\u003ch2\u003eAnalysis of test agreement\u003c/h2\u003e\n\u003cp\u003ePairwise agreement between fingerprick LumiraDx, serum LumiraDx, and serum CRPHS was examined using Lin\u0026rsquo;s concordance correlation coefficient (CCC), Passing\u0026ndash;Bablok (PB) regression, and Bland\u0026ndash;Altman (BA) analysis. CCC quantified overall concordance, with values closer to one reflecting stronger agreement. PB regression assessed systematic differences between methods, with no proportional bias if 95% confidence interval (CI) of the slope spans one, and no constant bias if the 95% CI of the intercept spans zero. The cumulative sum control chart (CUSUM) test assessed linearity assumption of PB regression, where p\u0026gt;0.05 indicates no evidence of non-linearity. BA analysis assessed agreement between paired measurements, providing mean bias and 95% limits of agreement [LoA; mean bias \u0026plusmn; 1.96 standard deviations (SD)], with points above or below the regression line indicating over- or underestimation relative to the other method (21-26). For PB and BA, only values within limits of quantification were included (n=168) to prevent distortion of agreement estimates (8, 27). And the n exceeds the recommended minimum of 40 for method comparison studies.\u003c/p\u003e"},{"header":"Results","content":"\u003ch2\u003eParticipant characteristics\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eOf the 1036 people with a prospective LumiraDx result and stored serum, 1034 had this serum successfully tested with LumiraDx. All of these were successfully tested with CRPHS. Among these participants, 63% (651/1034) were female, 85% (884/1034) HIV-negative and the median [interquartile range (IQR)] age 29 years (19-44; \u003cstrong\u003eTable 1\u003c/strong\u003e). 15% (156/1034) met the criteria for sputum microbiology,\u0026nbsp;11% (17/156) of which\u0026nbsp;had TB.\u003c/p\u003e\n\u003ch2\u003eCRP results\u003c/h2\u003e\n\u003cp\u003eThe proportion of fingerprick LumiraDx, serum LumiraDx, and serum CRPHS values below LODs were 64% (657/1034), 81% (842/1034), and 5% (55/1034), respectively (\u003cstrong\u003eTable 1\u003c/strong\u003e). In people with CRP above the LOD, mean\u0026plusmn;standard deviation (SD) concentrations were 19.1\u0026plusmn;40.1,\u0026nbsp;23.3\u0026plusmn;35.4, and\u0026nbsp;8.2\u0026plusmn;19.1\u0026nbsp;mg/L, respectively and 8.5\u0026plusmn;25.5,\u0026nbsp;6.4\u0026plusmn;17.2\u0026nbsp;and\u0026nbsp;7.8\u0026plusmn;18.7\u0026nbsp;mg/L when imputed values below LODs were included. Compared with LumiraDx,\u0026nbsp;serum CRPHS\u0026nbsp;classified a higher proportion of participants as having elevated CRP (\u0026gt;5 mg/L) [31% (318/1034) vs. 19% (199/1034) for fingerprick LumiraDx,\u0026nbsp;p\u0026lt;0.001; 31% (318/1034) vs. 18% (190/1034)\u0026nbsp;for serum LumiraDx,\u0026nbsp;p\u0026lt;0.001\u0026nbsp;(\u003cstrong\u003eTable 2\u003c/strong\u003e)].\u003c/p\u003e\n\u003ch2\u003eComparisons across tests and samples\u003c/h2\u003e\n\u003cp\u003eFingerprick and serum LumiraDx had the strongest concordance with CCC of 0.85, a PB slope of -0.27 (95% CI -0.82, 0.20), PB intercept of 1.1 (1.0, 1.1), and BA mean differences of +1 (-1, 3) with LoA -25 to +27 (\u003cstrong\u003eFigures 1-2,\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eSupplementary\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e). Serum LumiraDx and serum CRPHS showed moderate concordance (CCC of 0.79), with PB regression indicating a slight underestimation by serum LumiraDx [slope 1.1 (-1.1, 2.3), intercept 1.4 (1.3, 1.6)], and BA analysis showing a mean difference of +11 (9, 14), with LoA from -20 to +43. Fingerprick LumiraDx and\u0026nbsp;serum\u0026nbsp;CRPHS showed lowest concordance (CCC of 0.75), with PB regression indicating underestimation by Fingerprick LumiraDx [slope 1.3 (-0.6, 2.5), intercept 1.4 (1.3, 1.5)], and BA analysis showing a mean difference of +10 (8, 13), with LoA from -27 to +48. No deviations from linearity were observed (CUSUM linearity p=0.15 for\u0026nbsp;fingerprick LumiraDx\u0026nbsp;vs. serum; p\u0026gt;0.20 for each\u0026nbsp;LumiraDx\u0026nbsp;comparisons with\u0026nbsp;serum\u0026nbsp;CRPHS).\u003c/p\u003e\n\u003ch2\u003eDiagnostic accuracy of CRP for TB\u003c/h2\u003e\n\u003cp\u003eAUROCs were 0.747 (95% CI 0.595, 0.899) for fingerprick LumiraDx, 0.761 (0.628 ,0.893) for serum LumiraDx and 0.775 (0.636, 0.914) for serum CRPHS. At \u0026gt;5 mg/l,\u003csub\u003e\u0026nbsp;\u003c/sub\u003esensitivities were similar: 77% (70, 83) for fingerprick LumiraDx, serum LumiraDx, and serum CRPHS (\u003cstrong\u003eTable 3\u003c/strong\u003e).\u0026nbsp;However, serum CRPHS had a lower specificity\u0026nbsp;50%\u0026nbsp;(43, 58),\u0026nbsp;compared to fingerprick LumiraDx [60% (53, 68); p=0.002], and serum LumiraDx [64% (57, 72); p\u0026lt;0.001]. Similar trends were observed when\u0026nbsp;\u0026gt;10 mg/l was used.\u003c/p\u003e\n\u003ch2\u003eSpecimen freezing duration\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eNo significant slope [R=0.014 (-0.029, 0.059); p=0.128] was observed when readouts from fingerprick and serum LumiraDx were compared as function of the duration of serum storage (\u003cstrong\u003eFigure 3\u003c/strong\u003e).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eWe\u0026nbsp;investigated if CRP can be accurately measured on LumiraDx using serum in addition to fingerprick blood.\u0026nbsp;Our key findings are: 1) fingerprick and serum LumiraDx values showed strong agreement with similar AUROCs and sensitivities for TB and 2) LumiraDx (fingerprick or serum) tended to read slightly lower than serum CRPHS with CRPHS\u0026rsquo;s higher analytical sensitivity translating into reduced specificity for TB compared to LumiraDx (sensitivities were similar). Lastly, 3) there was no relationship between serum storage duration and LumiraDx performance. Together, these data suggest serum is a reliable alternative to testing of fingerprick blood using LumiraDx.\u003c/p\u003e\n\u003cp\u003eTo our knowledge, this is the first study to do serological LumiraDx CRP testing. We also compared serum readouts to those from fingerprick blood and included a highly sensitive laboratory-based test as a reference. Minimal proportional and small constant bias were observed, with fingerprick LumiraDx values slightly higher than serum, possibly due to storage or freeze-thaw. However, concordance and the modest BA mean difference suggest these methods are small enough to remain within clinically acceptable limits (21-23, 26), as illustrated by the similar AUROCs and diagnostic accuracy estimates, like those described else for CRP to diagnose TB (3, 28, 29).\u003c/p\u003e\n\u003cp\u003eWhen comparing serum CRPHS with fingerprick and serum LumiraDx, no significant proportional bias was observed, though LumiraDx tended to slightly underestimate CRP. Moreover, fingerprick and serum LumiraDx CRP each showed a similar trend compared with serum CRPHS, indicating that most variation arises from differences between testing platforms rather than specimen type or study design (prospective versus retrospective testing of thawed samples.\u003c/p\u003e\n\u003cp\u003eAll tests and sample types showed consistent sensitivities at \u0026gt;5 mg/L and \u0026gt;10 mg/L cutoffs. Serum CRPHS demonstrated lower specificity than fingerprick and serum LumiraDx, while specificities for the two LumiraDx methods were similar. This is likely due to its high analytical sensitivity that leads to more people without TB classified as \u0026ldquo;false-positive\u0026rdquo;, potentially due elevated yet relatively low levels of CRP associated with other causes of inflammation. More generally this finding suggests estimates of CRP performance may slightly overestimate specificity relative to symptoms if they used platforms with lower analytical sensitivity (3, 30, 31). Future meta-analyses should explore if test platform is associated with heterogeneity in diagnostic accuracy.\u003c/p\u003e\n\u003cp\u003eLastly, the duration that serum was frozen for did not affect fingerprick and serum LumiraDx performances. This aligns with studies demonstrating long-term stability of serum CRP over 4-14 years (32-34), and supports its retrospective measurement in studies (8).\u003c/p\u003e\n\u003cp\u003eA key strength of this study is the large size from three countries, each with a high TB and HIV burden, and, through the availability of microbiological reference standard for TB in a subset of people, the ability to assess whether the types of bias observed are clinically meaningful. Furthermore, to our knowledge, no studies have also evaluated point-of-care CRP testing in household contacts, a group with high TB risk. Limitations include a lack of technical replicates, which would have allowed a clearer distinction between systematic bias and normal analytical variation.\u003c/p\u003e\n\u003cp\u003eIn conclusion, our results demonstrate strong agreement between fingerprick and serum LumiraDx CRP measurements, with minimal clinically meaningful differences and comparable TB diagnostic performance. Importantly, serum storage duration had no impact on LumiraDx performance, supporting the practical use of serum testing when fingerprick sampling is not feasible. Lastly, estimates of CRP\u0026rsquo;s specificity for TB may be slightly overestimated if most data are from non-laboratory-based methods with high analytical sensitivity.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAC, SA, VL, APN, AK, WS, ALG, FC, and GT conceived and designed the study. APN, AK, MJ, WS, ALG, FC, GT acquired funding. AC, SA, PM, JS, DN, DM, AK, WS, ALG, GT coordinated patient recruitment activities. AC, SA, PM, JS, BM, DN, DM, MB and LN assisted with laboratory analysis and data curation. AC analysed the data. AC, SA, GT wrote the manuscript with input from all authors. All authors critiqued analyses and revised the manuscript. GT and AC had full access to all study data and final responsibility for the decision to submit for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclaration of interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe received in-kind donations from LumiraDx. LumiraDx had no role in study design, analysis, or results interpretation. The authors have no financial involvement with any organisation or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript apart from those disclosed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis project is part of the EDCTP2 programme supported by the European Union and received funding under grant agreement number RIA2018D-2509.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the study participants, and clinical teams for their contributions.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBlack S, Kushner I, Samols D (2004) C-reactive protein. 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J Clin Microbiol 59(1):02162\u0026ndash;02120. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1128/jcm\u003c/span\u003e\u003cspan address=\"10.1128/jcm\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSamuels TH, Wyss R, Ongarello S, Moore DA, Schumacher SG, Denkinger CM (2021) Evaluation of the diagnostic performance of laboratory-based c-reactive protein as a triage test for active pulmonary tuberculosis. PLoS ONE 16(7):e0254002\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDoumatey AP, Zhou J, Adeyemo A, Rotimi C (2014) High sensitivity C-reactive protein (Hs-CRP) remains highly stable in long-term archived human serum. Clin Biochem 47(4\u0026ndash;5):315\u0026ndash;318\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIshikawa S, Kayaba K, Gotoh T, Nakamura Y, Kario K, Ito Y et al (2007) Comparison of C-reactive protein levels between serum and plasma samples on long-term frozen storage after a 13.8 year interval: the JMS Cohort Study. J Epidemiol 17(4):120\u0026ndash;124\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003evan Waateringe RP, Muller Kobold AC, van Vliet-Ostaptchouk JV, van der Klauw MM, Koerts J, Anton G et al (2017) Influence of Storage and Inter-and Intra-Assay Variability on the Measurement of Inflammatory Biomarkers in Population-Based Biobanking. Biopreserv Biobank 15(6):512\u0026ndash;518\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cdiv class=\"SimplePara\"\u003eParticipants demographic and clinical characteristics stratified by site together with CRP results. CRP levels were higher in South African participants, consistent with the proportion of TB-positives. Data are n/N (%) or mean\u0026thinsp;\u003cspan type=\"Italic\" class=\"Italic\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;SD unless otherwise specified.\u003c/div\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003eOverall\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003en\u0026thinsp;=\u0026thinsp;1034\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003eMozambique\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e352/1034 (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e)\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003eUganda\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e305/1034 (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003eSouth Africa\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e377/1034 (36)\u003c/div\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eDemographics\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eAge\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003eMedian years (IQR)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e29 (19\u0026ndash;44)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e25 (16\u0026ndash;46)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e26 (18\u0026ndash;40)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e34 (22\u0026ndash;46)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eFemale\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e651/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(63)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e248/352\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(71)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e182/305\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(60)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e221/377\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(59)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eHIV-positive\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e150/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e70/352\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e23/305\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e57/377\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003eMicrobiology testing\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eEligible for sputum microbiology\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e156/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e35/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e11/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e110/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eTB-positive per MRS\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e17/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e0/35\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(0)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e2/11\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e15/110\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003eCRP\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eFingerprick LumiraDx (mg/L)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e8.5\u0026thinsp;\u0026plusmn;\u0026thinsp;25.5\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e5.2\u0026thinsp;\u0026plusmn;\u0026thinsp;19.4\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e5.8\u0026thinsp;\u0026plusmn;\u0026thinsp;16.7\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e13.9\u0026thinsp;\u0026plusmn;\u0026thinsp;34.0\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eProportion below LOD\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e657/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(64)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e309/352\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(88)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e201/305\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(66)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e147/377\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(39)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eIn those above LOD\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e19.1\u0026thinsp;\u0026plusmn;\u0026thinsp;40.1\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e24.7\u0026thinsp;\u0026plusmn;\u0026thinsp;51.9\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e12.1\u0026thinsp;\u0026plusmn;\u0026thinsp;27.6\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e21.1\u0026thinsp;\u0026plusmn;\u0026thinsp;42.0\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eSerum LumiraDx (mg/L)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e6.4\u0026thinsp;\u0026plusmn;\u0026thinsp;17.2\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e5.3\u0026thinsp;\u0026plusmn;\u0026thinsp;19.4\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e3.8\u0026thinsp;\u0026plusmn;\u0026thinsp;6.3\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e9.5\u0026thinsp;\u0026plusmn;\u0026thinsp;20.5\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.359\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.022\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.004\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eProportion below LOD\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e842/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(81)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e301/352\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(86)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e280/305\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(92)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e261/377\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(69)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.375\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eIn those above LOD\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e23.3\u0026thinsp;\u0026plusmn;\u0026thinsp;35.4\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e21.9\u0026thinsp;\u0026plusmn;\u0026thinsp;47.9\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e17.8\u0026thinsp;\u0026plusmn;\u0026thinsp;16.5\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e25.1\u0026thinsp;\u0026plusmn;\u0026thinsp;31.8\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.211\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.790\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.324\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.369\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eSerum CRPHS (mg/L)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e7.8\u0026thinsp;\u0026plusmn;\u0026thinsp;18.7\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e4.6\u0026thinsp;\u0026plusmn;\u0026thinsp;12.0\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e4.8\u0026thinsp;\u0026plusmn;\u0026thinsp;12.7\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e13.1\u0026thinsp;\u0026plusmn;\u0026thinsp;25.5\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.282\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.569\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.290\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.627\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.503\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.024\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eProportion below LOD\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e55/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e22/352\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e27/305\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e6/377\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eIn those above LOD\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e8.2\u0026thinsp;\u0026plusmn;\u0026thinsp;19.1\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e4.9\u0026thinsp;\u0026plusmn;\u0026thinsp;12.4\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e5.2\u0026thinsp;\u0026plusmn;\u0026thinsp;13.2\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e13.3\u0026thinsp;\u0026plusmn;\u0026thinsp;25.6\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.005\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eWithin row p-values: * differences across sites (ANOVA).\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eWithin column p-values: \u003csup\u003e\u0026dagger;\u003c/sup\u003e vs. fingerprick LumiraDx, \u003csup\u003e\u0026Dagger;\u003c/sup\u003e vs. serum LumiraDx. Abbreviations: SD, standard deviation; IQR, interquartile range; MRS, microbiological reference standard; LOD, limit of detection; CRPHS, cobas C‑Reactive Protein (Latex) High Sensitive.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eBold represents p-values\u0026thinsp;\u0026le;\u0026thinsp;0.05.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003cbr/\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cdiv class=\"SimplePara\"\u003eDistribution of CRP values by assay in all participants and those with microbiological testing. Serum CRPHS classified a higher proportion of participants as having elevated CRP (\u0026gt;\u0026thinsp;5 mg/L) than both fingerprick and serum LumiraDx. Data are n/N (%).\u003c/div\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"7\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003eAll participants\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(N\u0026thinsp;=\u0026thinsp;1034)\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003eParticipants with microbiological testing (N\u0026thinsp;=\u0026thinsp;156)\u003c/div\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eCRP range (mg/L)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026le;\u0026thinsp;5\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026gt;\u0026thinsp;5 to \u0026le;\u0026thinsp;10\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026gt;\u0026thinsp;10\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026le;\u0026thinsp;5\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026gt;\u0026thinsp;5 to \u0026le;\u0026thinsp;10\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026gt;\u0026thinsp;10\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eFingerprick LumiraDx\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e835/1034 (81)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e80/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e119/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e88/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(56)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003e17/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003e51/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eSerum LumiraDx\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e844/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(82)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e85/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e105/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e93/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(60)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003e17/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003e46/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.613\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.685\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.322\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.566\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.541\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eSerum CRPHS\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e716/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(69)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e132/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e186/1034\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e74/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(47)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003e17/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003e65/156\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(42)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.113\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.101\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.031\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.025\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"7\"\u003eWithin column p-values: \u003csup\u003e\u0026dagger;\u003c/sup\u003evs. fingerprick LumiraDx, \u003csup\u003e\u0026Dagger;\u003c/sup\u003e vs. serum LumiraDx\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003cbr/\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cdiv class=\"SimplePara\"\u003eDiagnostic accuracy of CRP at different positivity cut-offs for TB detection among contacts who had sputum microbiology (n\u0026thinsp;=\u0026thinsp;156). Sensitivity was similar across all tests and cut-offs. Serum CRPHS showed lower specificity than fingerprick or serum LumiraDx, and specificity was higher at the \u0026gt;\u0026thinsp;10 mg/L cutoff compared with \u0026gt;\u0026thinsp;5 mg/L. Data are % (95% CI).\u003c/div\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026gt;\u0026thinsp;5 mg/L\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u0026gt;\u0026thinsp;10 mg/L\u003c/div\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003eSensitivity\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003eSpecificity\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003eSensitivity\u003c/div\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003eSpecificity\u003c/div\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eFingerprick LumiraDx\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003eAUROC\u0026thinsp;=\u0026thinsp;0.747 (0.595, 0.899)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e77\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(70, 83)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e60\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(53, 68)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e71\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(63, 78)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e72\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(65, 79)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.317*\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eSerum LumiraDx\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003eAUROC\u0026thinsp;=\u0026thinsp;0.761 (0.628 ,0.893)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e77\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(70, 83)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e64\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(57, 72)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e59\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(51, 67)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e74\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(67, 81)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.083*\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.166\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.157\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.317\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cdiv class=\"SimplePara\"\u003eSerum CRPHS\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003eAUROC\u0026thinsp;=\u0026thinsp;0.775 (0.636, 0.914)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003e77\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(70, 83)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e50\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(43, 58)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003e77\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(70, 83)\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e63\u003c/div\u003e\u003cdiv class=\"SimplePara\"\u003e(55, 70)\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999*\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/span\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.002\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.317\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;=\u0026thinsp;0.002\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;\u0026gt;\u0026thinsp;0.999\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;0.083\u003csup\u003e\u0026Dagger;\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/span\u003e\u003csup\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e\u0026Dagger;\u003c/span\u003e\u003c/sup\u003e\u003c/div\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eWithin row p-values: * 5 vs. 10 mg/L\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eWithin column p-values: \u003csup\u003e\u0026dagger;\u003c/sup\u003e vs. fingerprick LumiraDx; \u003csup\u003e\u0026Dagger;\u003c/sup\u003e vs. serum LumiraDx\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eAbbreviations: AUROC, area under the receiver operating characteristic curve; CRPHS, cobas C‑Reactive Protein (Latex) High Sensitive.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eBold represents p-values\u0026thinsp;\u0026le;\u0026thinsp;0.05.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003cbr/\u003e"}],"fulltextSource":"","fullText":"","funders":[{"identity":"0f9aece9-481d-487e-aab0-3abcb53e6872","identifier":"10.13039/501100001713","name":"European and Developing Countries Clinical Trials Partnership","awardNumber":"RIA2018D-2509","order_by":0}],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"C-reactive protein, bioequivalence, tuberculosis contacts, LumiraDx","lastPublishedDoi":"10.21203/rs.3.rs-8161424/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8161424/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e C-reactive protein (CRP) is recommended to screen people living with HIV (PLWH) for tuberculosis (TB). LumiraDxis a portable platform that uses fingerprick blood. How CRP compares in fingerprick blood and serum is unknown.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e CRP was measured in 1034 consecutively recruited contacts of people with TB using fresh fingerprick blood (LumiraDx at point-of-care) and stored (-80°C) serum [LumiraDx and cobas C‑Reactive Protein (Latex) High Sensitive (CRPHS) in laboratories]. Agreement was assessed using Lin's concordance correlation coefficient (CCC), Passing-Bablok (PB) regression, and Bland-Altman (BA) plots. Sensitivity and specificity for TB were evaluated in 156 contacts with microbiological reference standard information.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Strong agreement [CCC=0.85, PB slope -0.27 (95% confidence interval -0.82, 0.2), BA mean difference 1 (-1, 3)] was observed between LumiraDx on fingerprick blood and serum. Similar agreement occurred for serum CRPHS vs. LumiraDx on serum [0.79; 1.1 (-1.1, 2.3); 11 (9, 14)] or fingerprick blood [0.75; 1.3 (-0.6, 2.5); 10 (8, 13)]. Areas under the receiver operating characteristic curves (AUROCs)were 0.747 (0.595, 0.899) for fingerprick LumiraDx, 0.761 (0.628, 0.893) for serum LumiraDx and 0.775 (0.636, 0.914) for serum CRPHS. At \u0026gt;5 mg/L, all tests showed identical sensitivity [77%(70, 83)]. Specificities were 60% (53, 68), 64% (57, 72) and 50% (43, 58), respectively. Serum storage duration did not affect performance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e LumiraDx CRP readouts on fingerprick blood and serum correlate closely. Stored serum can be used for LumiraDx CRP measurement. High sensitivity methods increase the proportion of people who screen false-positive.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding: \u003c/strong\u003eThis project is part of the EDCTP2 programme supported by the European Union and received funding under grant agreement number RIA2018D-2509.\u003c/p\u003e","manuscriptTitle":"Bioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-21 04:24:57","doi":"10.21203/rs.3.rs-8161424/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"30e1f45e-b329-4db4-8c8f-be529ea6330f","owner":[],"postedDate":"November 21st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-02-02T15:12:39+00:00","versionOfRecord":{"articleIdentity":"rs-8161424","link":"https://doi.org/10.1016/j.cca.2026.120876","journal":{"identity":"clinica-chimica-acta","isVorOnly":true,"title":"Clinica Chimica Acta"},"publishedOn":"2026-02-02 00:00:00","publishedOnDateReadable":"February 2nd, 2026"},"versionCreatedAt":"2025-11-21 04:24:57","video":"","vorDoi":"10.1016/j.cca.2026.120876","vorDoiUrl":"https://doi.org/10.1016/j.cca.2026.120876","workflowStages":[]},"version":"v1","identity":"rs-8161424","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8161424","identity":"rs-8161424","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}