Analytical Performance of Human Papillomavirus DNA Rapid Molecular Test for Cervical Cancer Screening in Adult Women in Indonesia: A Validation Study

Background & Objective: Cervical cancer continues to represent a major contributor to cancer-related mortality among women worldwide. Molecular-based Human Papillomavirus DNA testing due to greater sensitivity and specificity is recommended by WHO as the primary cervical cancer screening method. Recently, a new rapid molecular test has been developed to detect 15 high-risk HPV subtypes. This study was conducted with aim of comparing the analytical performance of a new rapid molecular PCR-based HPV DNA detection kit with an established HPV test. Materials & Methods: This cross-sectional study was conducted on women aged 30-65 eligible for HPV DNA screening. There were 30 women with biopsy results confirmed for cervical cancer and 31 women with normal pap smear. HPV DNA tests from clinician-collected cervical specimens were performed for both groups using the new rapid molecular PCR kit (InaHPV, Esora, Indonesia) and the established test (CerviScan, Bio Farma, Indonesia). We evaluated the sensitivity, specificity and assessed the agreement. Results: HPV DNA positivity for InaHPV was 44.3% and CerviScan 47.5%. A high level of agreement was identified between the InaHPV rapid molecular assay and the CerviScan test, as evidenced by a kappa coefficient of 0.868. The sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and overall accuracy of the InaHPV assay in the detection of HPV DNA were 89.6%, 96.8%, 91.2%, 96.2%, and 93.4%, respectively. Conclusion: Rapid molecular HPV DNA testing with InaHPV is comparable to established HPV-DNA test. It offers rapid turnaround time, simpler procedures and individual testing, suitable for areas with low resource settings.