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.

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.

The performance of gargling for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase (RT)-PCR testing has not been previously reviewed. This review systematically assessed the performance of saline and water gargling for SARS-CoV-2 RT-PCR testing in the settings of diagnosing and monitoring viral shedding.

Introduction: Mass testing is essential in the surveillance strategy for fighting the COVID-19 pandemic. It allows early detection of suspected cases and subsequently early isolation to mitigate spread. However, the high cost and limited consumables and reagents hinder the mass testing strategy in developing countries such as Indonesia. The specimen pooling strategy is an option to perform mass screening with limited resources. This study aims to determine the positivity rate cut-off and to evaluate the efficiency of pooling strategy for the laboratory diagnosis of COVID-19.
Methodology: Between August 4th, 2020, and November 11th, 2020, a four-sample pooling strategy testing to detect SARS-CoV-2 was carried out at the Microbiology Diagnostic Laboratory of Diponegoro National Hospital, Semarang, Indonesia. Pools with positive results were subjected to individual specimen retesting. Spearman’s correlation and linear regression analysis were used to determine the best positivity rate cut-off to apply pooling strategy. Results: A total of 15,216 individual specimens were pooled into 3,804 four-sample pools. Among these pools, 1,007 (26.47%) were positive. Five hundred and ten (50.64%) were 1/4 positive. A maximum positivity rate of 22% is needed to save at least 50% extraction and qRT-PCR reactions in a four-sample pooling strategy. CT values between individual specimens and pools showed a good interval agreement. Conclusions: Pooling strategy could reduce personnel workload and reagent cost, and increase laboratory capacity by up to 50% when the positivity rate is less than 22%.

OBJECTIVE: Real-time reverse transcription-polymerase chain reaction (RT-PCR) is the gold standard examination to confirm coronavirus disease 2019 (COVID-19). This study aimed to determine the association between RT-PCR Ct value and COVID-19 clinical severity in the second week of illness.
PATIENTS AND METHODS: This study was a cross-sectional study. Data were collected from medical records of COVID-19 patients at the tertiary COVID-19 referral hospital of West Java, Dr. Hasan Sadikin Hospital Bandung, from January to May 2021. A total of 207 patients who met inclusion criteria were divided into four severity groups. The data were analyzed with One Way ANOVA Test. RESULTS: There was no significant difference in RT-PCR Ct value among mild, moderate, severe and critical groups measured in the second week of illness, with p=0.825 for Ct Helicase/ORF1b gene, p=0.821 for Ct RdRp gene and p=0.870 for the lowest Ct gene. CONCLUSIONS: Although Ct value reflects viral load, its role is concluded to be clinically insignificant in terms of association with the severity of COVID-19 in the second week of illness.