To increase cervical cancer screening capacity and participation, we evaluated the performance of the newly developed high-risk human papillomavirus (hrHPV) ReadyMix qPCR Kit for detecting hrHPV in urine samples while genotyping for HPV-16, HPV-18, and HPV-52. A total of 876 samples were used to assess the performance of the hrHPV ReadyMix qPCR Kit in detecting hrHPV in standard cervical swab samples compared with that of the Roche Cobas 6800 HPV system. hrHPV detection in urine was compared with that in corresponding paired cervical swab samples. The sensitivity of the hrHPV ReadyMix qPCR Kit for HPV detection in cervical swab samples was 96.55%, and the specificity was 99.87%. Despite higher cycle threshold (Ct) values, urine samples demonstrated 80.88% sensitivity and 100.00% specificity compared with cervical swab samples. Our method enables population-based hrHPV analysis, with a 6.62% HPV prevalence determined via cervical swab samples and a 6.28% HPV prevalence determined via urine samples. Furthermore, the hrHPV ReadyMix qPCR Kit presented comparable HPV type distributions in urine samples and the ability to genotype HPV-16 and HPV-18 to those obtained via the Roche Cobas 6800 HPV system. Self-collected urine samples tested using the hrHPV ReadyMix qPCR Kit demonstrated a diagnostic accuracy of 98.48% for detecting hrHPV. This study highlights the potential of the hrHPV ReadyMix qPCR Kit to enhance cervical cancer screening, offering valuable insights for future interventions.

Scaling up SARS-CoV-2 testing and tracing continues to be plagued with the limitation of the sample collection method, which requires trained healthcare workers to perform and causes discomfort to the patients. In response, we assessed the performance and user preference of gargle specimens for qRT-PCR-based detection of SARS-CoV-2 in Indonesia. Inpatients who had recently been diagnosed with COVID-19 and outpatients who were about to perform qRT-PCR testing were asked to provide nasopharyngeal and oropharyngeal (NPOP) swabs and self-collected gargle specimens. We demonstrated that self-collected gargle specimens can be an alternative specimen to detect SARS-CoV-2 and the viral RNA remained stable for 31 days at room temperature storage. The developed method was validated for use on multiple RNA extraction kits and commercially available COVID-19 RT-PCR kits. Our developed method achieved a sensitivity of 91.38% when compared to paired NPOP swab specimens (Ct < 35), with 97.10% of patients preferring the self-collected gargle method.

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.