Human papillomavirus typing with a polymerase chain reaction-based genotyping array compared with type-specific PCR

• Published in: Journal of clinical virology 2008-08, Vol.42 (4), p.361-367
• Main Authors: Lin, Ching-Yu, Chao, Angel, Yang, Yuh-Cheng, Chou, Hung-Hsueh, Ho, Chih-Ming, Lin, Ruey-Wen, Chang, Ting-Chang, Chiou, Jia-Yia, Chao, Fang-Yu, Wang, Kung-Liahng, Chien, Tsai-Yen, Hsueh, Swei, Huang, Chu-Chun, Chen, Chien-Jen, Lai, Chyong-Huey
• Format: Article
• Language: English
• Subjects: Agreement; Allergy and Immunology; Biological and medical sciences; Cervix Uteri - virology; DNA, Viral - genetics; Female; Fundamental and applied biological sciences. Psychology; Genotype; HPV Blot; Human papillomavirus; Human viral diseases; Humans; Infectious Disease; Infectious diseases; Medical sciences; Microbiology; Miscellaneous; Papillomaviridae - classification; Papillomaviridae - genetics; Papillomaviridae - isolation & purification; Papillomavirus Infections - diagnosis; Papillomavirus Infections - virology; Polymerase Chain Reaction - methods; Sensitivity and Specificity; Type-specific PCR; Viral diseases; Virology
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2008.03.018

Abstract Background Type-specific persistence of human papillomavirus (HPV) infection can cause invasive cervical cancer. Objectives To evaluate the efficacy of HPV detection and typing with a general polymerase chain reaction (PCR)-based genotyping array and to compare it with a type-specific PCR assay. Study design Four hundred and thirty-three cervical samples were tested with a modified MY11/GP6+ PCR-based reverse-blot assay (EasyChip® HPV Blot; King Car, Taiwan [hereafter HPV Blot]) and with 20 genotypes of L1-type-specific PCR (HPV-6, -11, -16, -18, -31, -33, -35, -39, -45, -51, -52, -53, -56, -58, -59, -62, -66, -68, -70, and -71 [CP8061]). Results The concordance of the two tests in determining HPV positivity was 96.8% (419/433), with a Cohen's κ = 0.93 (95% CI: 0.90–0.97) and McNemar's test of P = 1.0, which indicates excellent agreement. The overall concordance of the two tests in the identification of type-specific HPV was 91.0% (394/433). Sensitivity (90–100%), specificity (99.2–100%), and accuracy (98.6–100%) rates of HPV Blot against the gold standard were satisfactory for HPV-16, -18, -58, -33, -52, -39, -45, -31, -51, -70 while HPV-71 (63.6%) had suboptimal sensitivity. Though the κ values between the two tests for many individual genotypes could not be reliably calculated because of low positivity, the κ values for HPV-16, -52, and -58 were excellent (0.93, 0.96, and 0.95, respectively). Conclusion The modified MY11/GP6+ PCR-based HPV Blot assay is accurate and sensitive for detection and genotyping of HPV in cervical swab samples.