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.


OBJECTIVE
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.


METHODS
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 kappa=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 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).


CONCLUSIONS
The modified MY11/GP6+ PCR-based HPV Blot assay is accurate and sensitive for detection and genotyping of HPV in cervical swab samples.
Lin
Ching-Yu
CY
School of Medical Laboratory Science and Biotechnology, Taipei Medical University, Taipei, Taiwan.
Chao
Angel
A
Yang
Yuh-Cheng
YC
Chou
Hung-Hsueh
HH
Ho
Chih-Ming
CM
Lin
Ruey-Wen
RW
Chang
Ting-Chang
TC
Chiou
Jia-Yia
JY
Chao
Fang-Yu
FY
Wang
Kung-Liahng
KL
Chien
Tsai-Yen
TY
Hsueh
Swei
S
Huang
Chu-Chun
CC
Chen
Chien-Jen
CJ
Lai
Chyong-Huey
CH
D002584:Cervix Uteri / Q000821:virology; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
D004279:DNA, Viral