Korean J Lab Med.  2008 Feb;28(1):70-78. 10.3343/kjlm.2008.28.1.70.

Clinical Efficacy of HPV DNA Chip Test in the Era of HPV Vaccination: 1,211 Cases, A Single Institution Study

• Kahng J
• Lee HJ

• KMID: 1781561
• DOI: http://doi.org/10.3343/kjlm.2008.28.1.70

Abstract

BACKGROUND: Human papillomavirus (HPV) prophylactic vaccines, bivalent types for HPV-16/18 with 70% prophylactic expectation, have been developed based on the genotypes found prevalent in the western countries, but little is known for those in Korea. Using a DNA chip test, we evaluated the clinical efficacy of HPV genotype based on cervical abnormalities.
METHODS
As the initial diagnostic tests, HPV DNA chip tests and Papanicolaou smear (PAP) were used for 1,211 subjects. Cervical colposcopy directed biopsies were performed for 626 among the 1,211 subjects within one month.
RESULTS
The most frequently found genotypes in all HPV-positive specimens (n=445) were HPV-16 (22.0%), 58 (13.9%), 52 (11.0%), 51 (9.0%), 56 (8.5%), and 18 (7.2%). HPV prevalence was significantly higher in specimens where PAP and biopsy results were closer to malignancy. The HPV genotype distribution of the histologically confirmed cervical high-grade squamous intraepithelial lesions (HSIL) or carcinoma cases showed HPV-16, 58, 52, 18, and 33, in descending order. The HPV DNA chip sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the detection of cervical HSIL or carcinoma were 76.9%, 70.1%, 72.1%, and 75.8%, respectively, Of these, the sensitivity and NPV were higher than those of PAP. PPV and NPV of HPV-16 were 90.5% and 60.7%, respectively, being the highest among the genotypes.
CONCLUSIONS
We confirmed that HPV-16 genotype was also very important for the diagnosis of HSIL and cervical carcinoma in Korea. However, contrary to the findings in the western countries, the prevalence of HPV-58 was higher than that of HPV-18. Moreover, as the other HPV genotype reports were rare in Korea, further studies are required with the HPV DNA chip test before the nationwide adoption of the vaccines.

Keyword

Human papillomavirus; Genotypes; DNA chip test; Clinical efficacy

MeSH Terms

Adolescent
Adult
Aged
Colposcopy
DNA, Viral/analysis/isolation & purification
Female
Genotype
Humans
Middle Aged
*Oligonucleotide Array Sequence Analysis
Papillomaviridae/classification/*genetics/isolation & purification
Papillomavirus Infections/*diagnosis/epidemiology/virology
Papillomavirus Vaccines
Polymerase Chain Reaction
Reproducibility of Results
Sensitivity and Specificity
Uterine Cervical Neoplasms/*diagnosis/prevention & control/virology
Vaginal Smears/methods
Young Adult

Figure

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  Fig. 1. Percent of patients infected with individual human papillomavirus (HPV) genotypes among age groups. Each type included single and multiple infections.

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  Fig. 2. Distribution of percent of patients infected with the individual high-risk human papillomavirus (HPV) genotypes. Each type included single and multiple infections. HPV-16 was the most prevalent type in HPV-infected women (chi-square test: P<0.001). LSIL, low-grade squamous intraepithelial lesion.

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