Lab-on-Chip assay of tumour markers and Human Papilloma Virus for cervical cancer detection at point-of-care

Cervical cancer affects over half a million people worldwide each year, the majority of whom are in resource-limited settingswhere cytology screening is not available. As persistent human papilloma virus (HPV) infections are a key causative factor,detection of HPV strains now complements cytology where screening services exist. This work demonstrates the efficacy of ahandheld Lab-on-Chip (LoC) device in detecting cervical cancer from biopsy samples. The device is based on Ion-SensitiveField-Effect Transistor (ISFET) sensors used in combination with loop-mediated isothermal amplification (LAMP) assays, toamplify HPV DNA and human telomerase reverse transcriptase (hTERT) mRNA. These markers were selected because of theirhigh levels of expression in cervical cancer cells, but low to nil expression in normal cervical tissue. The achieved analyticalsensitivity for the molecular targets resolved down to a single copy per reaction for the mRNA markers, achieving a limit ofdetection of 102for hTERT. In the tissue samples, HPV-16 DNA was present in 4/5 malignant and 2/5 benign tissues, withHPV-18 DNA being present in 1/5 malignant and 1/5 benign tissues. hTERT mRNA was detected in all malignant and nobenign tissues, with the demonstrated pilot data to indicate the potential for using the LoC in cervical cancer screening inresource-limited settings on a large scale