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KMID : 1039420160500040294
Journal of Pathology and Translational Medicine
2016 Volume.50 No. 4 p.294 ~ p.299
Clinical Significance of an HPV DNA Chip Test with Emphasis on HPV-16 and/or HPV-18 Detection in Korean Gynecological Patients
Yeo Min-Kyung

Lee Ah-Won
Hur Soo-Young
Park Jong-Sup
Abstract
Background:Human papillomavirus (HPV) is a major risk factor for cervical cancer.

Methods:We evaluated the clinical significance of the HPV DNA chip genotyping assay (MyHPV chip, Mygene Co.) compared with the Hybrid Capture 2 (HC2) chemiluminescent nucleic acid hybridization kit (Digene Corp.) in 867 patients.

Results:The concordance rate between the MyHPV chip and HC2 was 79.4% (kappa coefficient, ¥ê = 0.55). The sensitivity and specificity of both HPV tests were very similar (approximately 85% and 50%, respectively). The addition of HPV result (either MyHPV chip or HC2) to cytology improved the sensitivity (95%, each) but reduced the specificity (approximately 30%, each) compared with the HPV test or cytology alone. Based on the MyHPV chip results, the odds ratio (OR) for ¡Ã high-grade squamous intraepithelial lesions (HSILs) was 9.9 in the HPV-16/18 (+) group and 3.7 in the non-16/18 high-risk (HR)-HPV (+) group. Based on the HC2 results, the OR for ¡Ã HSILs was 5.9 in the HR-HPV (+) group. When considering only patients with cytological diagnoses of ¡°negative for intraepithelial lesion or malignancy¡± and ¡°atypical squamous cell or atypical glandular cell,¡± based on the MyHPV chip results, the ORs for ¡Ã HSILs were 6.8 and 11.7, respectively, in the HPV-16/18 (+) group.

Conclusions:The sensitivity and specificity of the MyHPV chip test are similar to the HC2. Detecting HPV-16/18 with an HPV DNA chip test, which is commonly used in many Asian countries, is useful in assessing the risk of high-grade cervical lesions.
KEYWORD
Human papillomavirus, DNA chip, Hybrid capture 2, Cervical intraepithelial neoplasia, Cervical carcinoma
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