Ko Kiwoong, Yu Shinae, Lee Eun Hee, Park Hyosoon, Woo Hee-Yeon, Kwon Min-Jung
Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Green Cross Reference Laboratory, Yongin, Kyunggi-do, Korea.
Ann Clin Lab Sci. 2016 Sep;46(5):522-8.
Various assays for detecting high-risk human papillomavirus (HR HPV) have been introduced recently, including the Abbott RealTime High-Risk HPV assay. We sought to compare the performance of Abbott PCR to Hybrid Capture 2 for the detection of HR HPV.
A total of 941 cervical swab specimens were obtained. We submitted all specimens for HR HPV detection with HC2 and Abbott PCR, and then additionally analyzed discordant and concordant positive results using restriction fragment mass polymorphism (RFMP) genotyping analysis.
HC2 detected one of 13 HR HPV types in 12.3% (116/941) of cases, while Abbott PCR detected one of 14 detectable HR HPV types in 12.9% (121/941) of cases. The overall agreement rate was 97.3% with a kappa coefficient of 0.879. Discordant results between these two assays were observed in 25 cases. HC2 showed a sensitivity of 90.0% and specificity of 95.9%, while Abbott PCR showed a sensitivity of 98.0% and specificity of 96.8% when using RFMP results as the gold standard. For HPV 16/18 detection, Abbott PCR showed 95.8%/88.9% sensitivity and 99.2%/99.8% specificity, respectively. The overall coinfection rate between HPV 16, 18 and non-16/18 was 9.9% (12/121) in Abbott PCR analysis.
Considering its high agreement rate with HC2, higher sensitivity/specificity compared to HC2, and ability to differentiate HPV 16/18 from other HPV types, Abbott PCR could be a reliable laboratory testing method for the screening of HPV infections.
近期已推出多种检测高危型人乳头瘤病毒（HR HPV）的检测方法，包括雅培实时高危型HPV检测法。我们旨在比较雅培聚合酶链反应（PCR）与第二代杂交捕获法（HC2）检测HR HPV的性能。
共获取941份宫颈拭子标本。我们将所有标本同时采用HC2和雅培PCR法进行HR HPV检测，然后使用限制性片段质量多态性（RFMP）基因分型分析对不一致和一致的阳性结果进行额外分析。
HC2在12.3%（116/941）的病例中检测到13种HR HPV类型中的一种，而雅培PCR在12.9%（121/941）的病例中检测到14种可检测的HR HPV类型中的一种。总体一致率为97.3%，kappa系数为0.879。在25例病例中观察到这两种检测方法的结果不一致。以RFMP结果作为金标准时，HC2的灵敏度为90.0%，特异性为95.9%，而雅培PCR的灵敏度为98.0%，特异性为96.8%。对于HPV 16/18检测，雅培PCR的灵敏度分别为95.8%/88.9%，特异性分别为99.2%/99.8%。在雅培PCR分析中，HPV 16、18与非16/18之间的总体共感染率为9.9%（12/121）。
鉴于雅培PCR与HC2的高一致率、相比HC2更高的灵敏度/特异性以及区分HPV 16/18与其他HPV类型的能力，它可能是一种用于筛查HPV感染的可靠实验室检测方法。
