Comparative Performances Of Four Severe Acute Respiratory Syndrome-Coronavirus-2 Real-Time Polymerase Chain Reaction Assays For The Diagnosis Of COVID-19 In Ethiopia

Abstract Since coronavirus disease-2019 (COVID-19) outbreak was reported, many commercial Nucleic Acid Amplification Testing (NAAT) assays have been developed all over the world, and it has been the standard method. Though, a number of assays were rapidly developed and applied to clinical testing, performance of these assays were not evaluated in different contexts. Thus, this study was aimed to assess the performance of common assays (Abbott SARS-CoV-2, DaanGene, BGI and Sansure Biotech) available in Ethiopia by using combined reference results (CRR). The study was conducted at Ethiopian Public Health Institute (EPHI) from December 1 to 30/2020. A total of 164 nasopharyngeal samples were extracted by using QIAamp® RNA mini kit and Abbott DNA sample preparation system. Out of 164 samples, 59.1% was positive and 40.9% was negative by CRR. Sansure Biotech positivity was significantly low compared to CRR (p<0.05). The overall agreement of the four assays compared to CRR was 96.3% to 100%. The performance of four assays had almost comparable diagnostic performance, except a low positive rate of Sansure Biotech assay. Hence, Sansure Biotech assay (RUO) needs further verification on its use in Ethiopia. Finally, an additional study should be considered for the evaluation of assays with respective manufacturer claims.