A comparison of two strategies that detect human papillomavirus in ThinPrep cytology samples - a preliminary study.

Daniel C.C. Tam¹, Chris K.L. Wai¹, W.C. Yam², Stephen T.H. Lo³, C.W. Chan⁴, P.S. Cheng¹ and C.S. Ng³

¹Genepath Technology Limited,
²Department of Microbiology, University of Hong Kong, Queen Mary Hospital Compound,
³Department of Pathology, Caritas Medical Centre, Shamshuipo, Kowloon, and
⁴Biotech Limited.

In order to evaluate the clinical use of the polymerase chain reaction (PCR) and Hybrid Capture II (HC-II) for the detection of genital human papillomavirus (HPV) in liquid based cytology (ThinPrep) samples, a sample of 40 patients who attend routine cervical cancer screening were randomly recruited. HPV DNA was detectable among the cohort of 40 patients undergoing cervical cytology screening by the PCR and HC-II in 57.5% (23/40) and 40.0% (16/40) respectively. The overall concordance was 77.5% and HC-II sensitivity and specificity versus PCR were 65.2% and 94.1%. PCR sensitivity and specificity versus HC-II were 93.8% and 66.7%. For sample with normal cytology, the agreement between both assays was 70.8%. Sensitivity, specificity, positive predictive value and negative predictive value of the HC-II test were 41.7%, 100.0%, 100.0% and 63.2% respectively. For samples with abnormal cytology, the level of agreement was 87.5%. Sensitivity, specificity, positive predictive value and negative predictive value of the HC-II test were 90.9%, 80.0%, 90.9% and 80.0% respectively. The results of PCR and the HC-II assay indicated good reproducibility. For sample with abnormal cytology, the concordance was good and resulting in substantial reproducibility.

Keywords: Cervix Neoplasms, DNA, Viral, Papillomavirus, Human, Polymerase Chain Reaction, Sensitivity and Specificity.

View Full Text