Comparative analysis of pathoscan hrHPV qPCR kits with four- and five-channel qPCR methods for the identification of high-risk human papillomaviruses

Introduction: In Indonesia, cervical cancer remains a serious health concern. WHO recommends high-risk human papillomavirus (hrHPV) DNA testing as the primary tool of screening instead of cytology and visual inspection with acetic acid. The Indonesian government has been encouraging the usage of locally manufactured medical devices including laboratory supplies and reagent kits. PathoScan hrHPV qPCR kit (PT Riset Nusantara Genetika, Nusantics Group, Indonesia) is one of the locally manufactured kits and was originally designed for 5-channel qPCR for hrHPV DNA detection. However, most clinical laboratories in Indonesia employ 4-channel qPCR instruments. Therefore, the PathoScan hrHPV Lite qPCR kit was developed as an alternative, needing only a 4-channel qPCR instrument. This study aims to assess its diagnostic performance in comparison to the PathoScan hrHPV qPCR kit Methods: This is a cross-sectional study evaluating the PathoScan hrHPV Lite qPCR kit (4-channel) on 96 cervical swab samples that were previously tested with the PathoScan hrHPV qPCR kit (5-channel) to determine its diagnostic performance using the following metrics: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Bland-Altman analysis was utilized to evaluate the agreement between Ct values obtained between the two methods. Result: The diagnostic performance of the kit was assessed on 96 cervical swab samples, which comprised 47 positive and 49 negative samples as determined by the PathoScan kit. The PathoScan hrHPV Lite qPCR kit's sensitivity in the present study was 100% (95% CI 92.29-100%) and the specificity observed was 100% (95% CI 92.75-100%). The Bland-Altman plot indicated good agreement with <5% results falling beyond the acceptable upper and lower limits. Conclusion: PathoScan hrHPV Lite qPCR kit displayed excellent diagnosis accuracy and good agreement, suggesting it can be used for primary cervical cancer screening.