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 ۱۵ 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 ۳۰-۶۵ eligible for HPV DNA screening. There were ۳۰ women with biopsy results confirmed for cervical cancer and ۳۱ 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 ۴۴.۳% and CerviScan ۴۷.۵%. A high level of agreement was identified between the InaHPV rapid molecular assay and the CerviScan test, as evidenced by a kappa coefficient of ۰.۸۶۸. 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 ۸۹.۶%, ۹۶.۸%, ۹۱.۲%, ۹۶.۲%, and ۹۳.۴%, 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.

کلیدواژه ها:

Human papillomavirus ، DNA ، Cervical cancer ، Polymerase chain reaction