A comparison of a prototype PCR assay and hybrid capture 2 for detection of carcinogenic human papillomavirus DNA in women with equivocal or mildly abnormal papanicolaou smears
A comparison of a prototype PCR assay and hybrid capture 2 for detection of carcinogenic human papillomavirus DNA in women with equivocal or mildly abnormal papanicolaou smears
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DOI：
10.1309/e067x0l1u3cy37nw
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发表时间：
2005-11-01
影响因子：
3.5
通讯作者：
Castle, PE
中科院分区：
文献类型：
--
作者：
Schiffman, M;Wheeler, CM;Castle, PE
我们评估了杂交捕获2（HC 2）和聚合酶链反应（PCR）结果的配对标本收集在19,187次访问从5,026 5,060名妇女参加了非典型鳞状细胞的意义不明/低度鳞状上皮内病变分类研究（ALTS）。我们检查了HC 2和PCR检测对HC 2靶向的13种致癌性人乳头瘤病毒类型中的任何一种的检测一致性，并比较了2种检测方法检测并发和随访宫颈上皮内瘤变（CIN）3或癌症的临床性能。2种检测方法的kappa值为0.65（95%置信区间，0.64-0.66），粗一致率为82.7%。HC 2在检测2年累积CIN 3或癌症（n = 503）方面比PCR更敏感（93.6%vs 89.3%; P <0.0005）但特异性较低（41.2%vs 48.5%; P <0.0005）。通过PCR和/或细胞学异常检测到的多种类型的存在增加了HC 2+结果的可能性。考虑到基于PCR的方法在分析灵敏度方面的理论优势，与PCR相比，HC 2的灵敏度增加是令人惊讶的。PCR中使用的少量材料可能会限制其灵敏度，但我们的结果表明了优化和标准化基于PCR的检测方法对临床应用的重要性。
We evaluated Hybrid Capture 2 (HC2) and polymerase chain reaction (PCR) results for paired specimens collected at 19,187 visits from 5,026 of 5,060 women participating in the Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS). We examined the test agreement between HC2 and PCR detection for any of 13 carcinogenic human papillomavirus types targeted by HC2 and compared clinical performance of the 2 tests for detecting concurrent and follow-up cervical intraepithelial neoplasia (CIN) 3 or cancer.The kappa value for the 2 assays was 0.65 (95% confidence interval, 0.64-0.66), with, 82.7% crude agreement. HC2 was more sensitive (93.6% vs 89.3%; P < .0005) but less specific (41.2% vs 48.5%; P < .0005) than PCR for detecting 2-year cumulative CIN 3 or cancer (n = 503). The presence of multiple types as detected by PCR and/or cytologic abnormality increased the likelihood of an HC2+ result.Increased sensitivity of HC2 compared with PCR was surprising given the theoretical advantages of PCR-based methods for analytic sensitivity. Smaller amounts of material used in PCR could have limited its sensitivity, but our results demonstrate the importance of optimization and standardization of PCR-based assays for clinical applications.