Comparison of linear array and line blot assay for detection of human papillomavirus and diagnosis of cervical precancer and cancer in the atypical squamous cell of undetermined significance and low-grade squamous intraepithelial lesion triage study
Comparison of linear array and line blot assay for detection of human papillomavirus and diagnosis of cervical precancer and cancer in the atypical squamous cell of undetermined significance and low-grade squamous intraepithelial lesion triage study
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DOI：
10.1128/jcm.01667-07
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发表时间：
2008-01-01
影响因子：
9.4
通讯作者：
Schiffman, Mark
中科院分区：
文献类型：
--
作者：
Castle, Philip E.;Gravitt, Patti E.;Schiffman, Mark
我们评估了一种新的商业化的PGW09/11 L1通用引物聚合酶链式反应试验(LA)，它通过反向线点杂交检测37种人乳头状瘤病毒(HPV)基因，用于检测单个HPV基因型和致癌HPV，并使用来自未确定意义的非典型鳞状细胞(ASCUS)和低度鳞状上皮内病变分流研究的存档标本，评估其在检测两年累积宫颈癌前病变和癌症方面的临床表现。LA检测是对因ASCUS巴氏试验而转诊的妇女的登记样本进行的。为了评估新测试的性能，将结果与其前身原型分析(LBA)的结果进行了比较，仅限于配对结果(n=3335)。LA测试是在屏蔽LBA结果和临床结果的情况下进行的。比较LA和LBA检测宫颈癌前病变和癌前病变的致癌HPV和临床转归。总体而言，分别有50%和55%的妇女通过LBA和LA检测出致癌HPV阳性(P<；0.0001)。两种方法检测致癌HPV的符合率为88%，阳性符合率为80%，kappa为0.76。LA对两种检测方法所针对的37种HPV基因中的大多数的检测都有显著增加，包括14种致癌HPV基因中的13种。LA在人乳头瘤病毒阳性妇女中检测到更多的人乳头瘤病毒感染(P<；0.0001)，在致癌的人乳头瘤病毒阳性妇女中检测到更多的致癌人乳头瘤病毒感染(P<；0.0001)。对于病理质量控制小组诊断的2年累计宫颈癌前病变和癌，LA比LBA更敏感(92.3%比87.1%；P=0.003)，而特异性(48.2%比54.0%；P<；0.0001)。综上所述，我们发现LA是一种很有前途的检测HPV基因型别和致癌HPV的方法，并可能在临床上用于检测宫颈癌前病变和细胞学可疑的女性的癌症。
We evaluated Linear Array (LA), a newly commercialized PGW09/11 L1 consensus primer PCR test that detects 37 human papillomavirus (HPV) genotypes by reverse line blot hybridization, for the detection of individual HPV genotypes and carcinogenic HPV and its clinical performance for detecting 2-year cumulative cervical precancer and cancer using archived specimens from the Atypical Squamous Cell of Undetermined Significance (ASCUS) and Low-Grade Squamous Intraepithelial Lesion Triage Study. LA testing was conducted on enrollment specimens from women referred because of an ASCUS Pap test. To gauge the performance of the new test, the results were compared to those of its prototype predecessor assay, Line Blot Assay (LBA), restricted to paired results (n = 3,335). LA testing was done masked to LBA results and clinical outcomes. The results of LA and LBA testing were compared for detection of carcinogenic HPV and clinical outcomes of cervical precancer and cancer. Overall, 50% and 55% of the women tested positive for carcinogenic HPV by LBA and LA, respectively (P < 0.0001). The percent agreement for carcinogenic HPV detection was 88%, percent positive agreement was 80%, and kappa was 0.76 for detection of carcinogenic HPV by the two assays. There was a significant increase in detection by LA for most of the 37 HPV genotypes targeted by both assays, including for 13 of 14 carcinogenic HPV genotypes. LA detected more multiple-genotype infections for all HPV genotypes among HPV-positive women (P < 0.0001) and for carcinogenic HPV genotypes among carcinogenic-HPV-positive women (P < 0.0001). LA was more sensitive (92.3% versus 87.1%; P = 0.003) and less specific (48.2% versus 54.0%; P < 0.0001) than LBA for 2-year cumulative cervical precancer and cancer as diagnosed by the Pathology Quality Control Group. In conclusion, we found LA to be a promising assay for the detection of HPV genotypes and carcinogenic HPV, and it may be clinically useful for the detection of cervical precancer and cancer in women with equivocal cytology.