Comparison of CerviHPV and Hybrid Capture 2 HPV tests for detection of high‐risk HPV infection in cervical swab specimens

Abstract

Background Persistent high‐risk human papillomavirus (HR‐HPV) infection is the etiological cause of virtually all cervical cancer cases. HR‐HPV screening achieved with earlier generations of HR‐HPV tests has been instrumental in the prevention and early detection of cervical cancer worldwide. The first FDA‐approved HR‐HPV test, digene Hybrid Capture 2 HPV DNA Test (HC2), has been prominent in these efforts. Newer tests have since been developed to improve upon the capability of HC2 test. Methods To evaluate the performance of a new multiplex real‐time quantitative PCR assay for HR‐HPV detection, CerviHPV HR‐HPV Test (CerviHPV), 232 cervical swab specimens were collected and analyzed by HC2 and CerviHPV tests for comparison. Results HC2 test detected 69 (29.7%) positive cases, whereas CerviHPV test reported 43 (18.5%) positive cases. The concordance rate between the two tests was 84.5% with a kappa value of 0.579. Additional analyses identified only HPV66 or low‐risk HPV (LR‐HPV) types in six HC2 positive discordant cases, suggesting these HC2 results to be false positive. Conclusion CerviHPV test has two advantages over HC2 test: It contains a cellular control to eliminate false negative results due to failed sample collection and processing, and it can simultaneously detect and genotype the two most carcinogenic HPV types, HPV16 and 18. In this comparison study, CerviHPV test also demonstrated higher analytical specificity for HR‐HPV genotypes than HC2 test. Therefore, CerviHPV test has the potential to become a viable option for cervical cancer screening in the clinics.

Prevalence of oral and anal human papillomavirus infection in Czech predominantly HIV-positive men having sex with men - data from a previously unreported population

“…Some studies did not exclude such samples or performed HPV detection without an internal control of the amplification/reaction, e.g., HC2 technique. 26 Further, targeting more than one HPV gene for PCR detection increased the rate of positivity. In the meta-analysis by Farahmand, studies using both L1 and E6 genes for PCR detection had a higher positivity compared to those targeting the L1 gene or E1 gene alone.…”

A Cautionary Tale of Cross-Contamination Among Plasmids from Commercial Suppliers

“…The CerviHPV test (GWP Biotechnology Co. Ltd., Suzhou, China) is a TaqMan-based multiplex quantitative PCR (qPCR)-based high-risk human papillomavirus (HR-HPV) detection assay [25]. It simultaneously detects 14 HR-HPV types -HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 -in a single reaction tube.…”

“…HR-HPV Genotyping Assay (GWP Biotechnology Co. Ltd.) is a TaqManbased qPCR assay that genotypes 12HPV types [25]. It employs three five-channel multiplex qPCR reactions, each of which can individually identify four 12HPV types.…”

“…The qPCR products of reactions with unexpected amplification signals were first purified by the PCR Product Purification Kit (Sangon Biotech Co. Ltd., Shanghai, China) and the purified products were subsequently sequenced by Genewiz Inc. (Suzhou, China), with specific primers for the contaminating templates [25]. The resulting DNA sequences were queried on the BLAST website [26] to determine their identities.…”

Combining Serum DNA Methylation Biomarkers and Protein Tumor Markers Improved Clinical Sensitivity for Early Detection of Colorectal Cancer

“…Therefore, a low-cost, convenient, and more accurate screening method will go a long way to promote early CRC screening in China. The ColoDefense test that we have recently developed just may become such an alternative [7][8][9]. It is a multiplex quantitative PCR (qPCR) assay simultaneously detecting methylated DNA biomarkers within septin 9 (SEPT9) and syndecan 2 (SDC2) genes.…”