ABSTRACT
BACKGROUND: The HPV28 Detection test (Seegene) is a real-time polymerase chain reaction assay that is designed for testing a total of 28 human papillomavirus (HPV) genotypes and estimating the approximate HPV viral load. The aim of this study was to evaluate the clinical applicability of the HPV28 Detection test with regard to the prevalence of HPV infection and distribution of HPV genotypes by using the HPV28 Detection and HPV DNA Chip tests (Biomedlab). METHODS: HPV DNA Chip and HPV28 Detection tests were performed for 500 cervical swab specimens. HPV genotype results were confirmed by sequencing analysis of the specimens that showed discordant results in the 2 test methods. RESULTS: The positive rate of HPV detection determined by using HPV28 Detection and HPV DNA Chip tests were 43.8% and 40.6%, respectively. The sequencing results in 64 discordant specimens that showed single HPV infection in the 2 test methods were in complete agreement with the test results obtained with the HPV28 Detection test. The genotyping results of the HPV28 Detection test were 100% concordant in repeated experiments with HPV-infected specimens that have 12 different HPV genotypes, i.e., types 16, 31, 33, 39, 42, 51, 52, 53, 58, 66, 68, and 70. The HPV28 Detection test was 100-fold more sensitive than the HPV DNA Chip test with serially diluted HPV DNAs. CONCLUSIONS: The HPV28 Detection test can be applied in the clinical field as an HPV genotyping test can accurately identify various HPV genotypes with high specificity and low detection limit.