Human Papillomavirus Typing with a Polymerase Chain Reaction-Based Genotyping Array Compared with Type-Specific Pcr

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 MY 11/GP6+ PCR-based reverse-blot assay (EasyChip(R) 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 kappa = 0.93 (95% Cl: 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 kappa values between the two tests for many individual genotypes could not be reliably calculated because of low positivity, the kappa 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