基于聚合酶链反应的基因分型阵列进行人乳头瘤病毒分型并与型特异性聚合酶链反应相比较。
Human papillomavirus typing with a polymerase chain reaction-based genotyping array compared with type-specific PCR.
作者信息
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
机构信息
School of Medical Laboratory Science and Biotechnology, Taipei Medical University, Taipei, Taiwan.
出版信息
J Clin Virol. 2008 Aug;42(4):361-7. doi: 10.1016/j.jcv.2008.03.018. Epub 2008 May 2.
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 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).
CONCLUSION
The modified MY11/GP6+ PCR-based HPV Blot assay is accurate and sensitive for detection and genotyping of HPV in cervical swab samples.
背景
人乳头瘤病毒（HPV）感染的型特异性持续存在可导致浸润性宫颈癌。
目的
评估基于通用聚合酶链反应（PCR）的基因分型芯片进行HPV检测和分型的效果，并将其与型特异性PCR检测进行比较。
研究设计
采用改良的基于MY11/GP6 + PCR的反向杂交检测法（EasyChip HPV Blot；台湾金车公司[以下简称HPV Blot]）和20种L1型特异性PCR（HPV - 6、 - 11、 - 16、 - 18、 - 31、 - 33、 - 35、 - 39、 - 45、 - 51、 - 52、 - 53、 - 56、 - 58、 - 59、 - 62、 - 66、 - 68、 - 70和 - 71[CP8061]）对433份宫颈样本进行检测。
结果
两种检测方法在确定HPV阳性方面的一致性为96.8%（419/433），Cohen's kappa值 = 0.93（95%CI：0.90 - 0.97），McNemar检验P = 1.0，表明一致性极佳。两种检测方法在鉴定型特异性HPV方面的总体一致性为91.0%（394/433）。HPV Blot针对HPV - 16、 - 18、 - 58、 - 33、 - 52、 - 39、 - 45、 - 31、 - 51、 - 70的灵敏度（90 - 100%）、特异性（99.2 - 100%）和准确率（98.6 - 100%）对金标准来说是令人满意的，而HPV - 71（63.6%）的灵敏度欠佳。尽管由于阳性率低，两种检测方法对许多个体基因型的kappa值无法可靠计算，但HPV - 16、 - 52和 - 58的kappa值极佳（分别为0.93、0.96和0.95）。
结论
改良的基于MY11/GP6 + PCR的HPV Blot检测法在宫颈拭子样本中对HPV的检测和基因分型准确且灵敏。
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