Comparative Evaluation of the HPV28 Detection and HPV DNA Chip Test for Detecting and Genotyping Human Papillomaviruses

Eunsim Shin; Heojin Bae; Wan-Keun Song; Sun-Kyung Jung; Yoo-Sung Hwang

doi:10.3343/lmo.2013.3.4.234

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Shin, Bae, Song, Jung, and Hwang: Comparative Evaluation of the HPV28 Detection and HPV DNA Chip Test for Detecting and Genotyping Human Papillomaviruses

Original Article

Clinical Microbiology

Laboratory Medicine Online 2013; 3(4): 234-241.

Published online: 1 October 2013

DOI: https://doi.org/10.3343/lmo.2013.3.4.234

Comparative Evaluation of the HPV28 Detection and HPV DNA Chip Test for Detecting and Genotyping Human Papillomaviruses

Eunsim Shin, Ph.D., Heojin Bae, M.T., Wan-Keun Song, M.S., Sun-Kyung Jung, M.D., Yoo-Sung Hwang, M.D.

Molecular Diagnostics Testing Center, Neodin Medical Institute, Seoul, Korea.

Corresponding author: Yoo-Sung Hwang. Molecular Diagnostics Testing Center, Neodin Medical Institute, 320 Cheonho-daero, Seongdong-gu, Seoul 133-847, Korea. Tel: +82-2-2244-6500, Fax: +82-2-2212-4383, hwangys@neodin.com

Received 29 May 2013 Revised 11 July 2013 Accepted 12 July 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: HPV Genotyping, Human Papillomavirus, HPV DNA Chip, Real-Time PCR

Figures and Tables

Fig. 1

Frequencies of human papillomavirus genotypes with the HPV28 Detection and HPV DNA Chip tests for 500 cervical specimens.

Table 1

Positive rate and prevalence of HPV genotypes with the HPV28 Detection and HPV DNA Chip genotyping tests for 500 cervical specimens

Abbreviations: HPV, human papillomavirus; NA, not available.

Table 2

Agreement of the HPV28 Detection tests by repeat measurement of samples with discordant HPV genotyping results between the HPV28 Detection and HPV DNA Chip tests

^*(w), Type-specific signal intensity was weaker than the signal intensity of the positive control; ^†Other, The HPV genotype was not identified although the test for HPV infection was positive.

Abbreviation: HPV, human papillomavirus.

Table 3

Determination of the limit of detection (LOD) for the HPV genotypes 16, 18, 52 and 58

^*Other: The HPV genotype was not identified although the test for HPV infection was positive.

Abbreviations: HPV, human papillomavirus; Neg, Negative.

Notes

This article is available from http://www.labmedonline.org

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