Abstract
The detection of high-risk human papillomavirus (HR-HPV) is important for early diagnosis of precancerous cervical lesion. The distribution of HR-HPV genotypes in East Asia is different from that in Western countries. HR-HPVs non-16/18 including HPV-58 are highly prevalent in East Asia. Thus, a variety of HPV tests that could identify individual genotypes have been widely used. HPV 9G DNA is a deoxyribonucleic acid-based chip test, while PANArray HPV chip is a peptide nucleic acid-based array. We compared the analytic performance of these two chips for detecting and genotyping HR-HPV using 356 liquid-based cytology specimens and evaluated their diagnostic accuracies based on direct sequencing. For identifying HR-HPV, PANArray HPV and HPV 9G DNA chips agreed with each other for 85.1% of samples. Overall strength of agreement between the two tests was substantial (k = 0.68). Specifically, these two tests almost perfectly agreed for detecting several types of HR-HPV, including HPV-16, -18, -35, -52, -58, and -59 (k>0.81 for all). According to direct sequencing, PANArray HPV produced consistently higher sensitivities for detecting HR-HPV than HPV 9G DNA for either overall or individual genotypes of HR-HPV. Sensitivities and specificities for detecting HPV-58 were perfect (100%) with PANArray HPV. In conclusion, PANArray HPV is more effective than HPV 9G DNA in detecting HR-HPV. It is more useful for regions with high prevalent HPV-58 infection.
Highlights
Papanicolaou (Pap) test contributes to incidence reduction of cervical cancer, Pap screening test alone was limited due to its low sensitivity and reproducibility for detecting high-grade squamous intraepithelial lesions (HSILs) of uterine cervix [1]
All deoxyribonucleic acid (DNA) specimens were stored at -70 ̊C until they were re-assayed for human papillomavirus (HPV) 9G DNA and PANArray HPV tests and direct sequencing
We compared overall frequencies of 14 high-risk human papillomavirus (HR-HPV) and 5 LR-HPVs that could be identified by both tests (Table 2)
Summary
Papanicolaou (Pap) test contributes to incidence reduction of cervical cancer, Pap screening test alone was limited due to its low sensitivity and reproducibility for detecting high-grade squamous intraepithelial lesions (HSILs) of uterine cervix [1]. Several HPV genotyping tests, mostly polymerase chain reaction (PCR)-based deoxyribonucleic acid (DNA) microarray methods, are widely used in Korea. Among HPV genotyping tests, HPV 9G DNA chip (Biometrix Technology Inc., Chuncheon, Korea) can detect 19 HPVs individually, including 14 high-risk (HR) and 5 low-risk (LR) types at the same time [7, 8](Table 1). PANArray HPV chip (Panagene Inc., Daejeon, Korea) is a peptide nucleic acid (PNA)based test that could detect five more HR-HPV and eight more LR-HPV genotypes than HPV 9G DNA chip (Table 1)[9]. We compared the performance of PANArray HPV and HPV 9G DNA chip tests for detecting and genotyping HR-HPVs. In addition, we validated genotyping results of these two tests by direct sequencing to compare their diagnostic accuracies
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