Comparison of Alinity m HPV and cobas HPV assays on cervical specimens in diverse storage media

IF 4.7 Q1 VIROLOGY Tumour Virus Research Pub Date : 2021-12-01 DOI:10.1016/j.tvr.2021.200224

Dan Jang , Sam Ratnam , Marek Smieja , David J. Speicher , Manuel Arias , Avery Clavio , Dustin Costescu , Laurie Elit , Shihai Huang , Erika Herrero-Garcia , Ajith M. Joseph , Hao Jiang , Robert Needle , Max Chernesky

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引用次数: 2

Abstract

Objective

To assess the concordance of high-risk HPV (HR-HPV) testing with the Alinity assay on cervical samples collected with diverse collection/storage protocols (ThinPrep, SurePath, Cervicollect) and to assess inter-assay concordance of HR-HPV testing of cervical cell specimens with Alinity m HR HPV assay (Alinity) vs cobas® 4800 HPV assay (cobas).

Methods

Specimens were obtained from 560 women attending a Women's Health clinic. Two specimens were obtained from each woman with combinations of two of the three collection devices and aliquots were tested by the two assays.

Results

Alinity showed an agreement of 93.9%, Kappa = 0.89 (263/280) between ThinPrep and SurePath specimens; 97.5%, Kappa = 0.95 (347/356) and 92.9%, Kappa = 0.85 (104/112) between ThinPrep and SurePath aliquots taken before or after cytology processing, respectively. Cervi-Collect specimens showed an agreement of 94.6%, Kappa = 0.89 (265/280) with ThinPrep specimens. Compared to cobas, Alinity showed agreements of 94.3%, Kappa = 0.88 (395/419) and 91.8%, Kappa = 0.82 (257/280) between ThinPrep and SurePath specimens, respectively. Alinity and cobas detected genotypes 16/18 and other high-risk HPV types at similar rates and showed similar correlations with cytology grades.

Conclusions

Compared to cobas, Alinity performed equally well for detecting HPV in cervical specimens obtained with ThinPrep and SurePath. The Cervi-Collect device compared well to the other collection methods. Alinity is a reliable assay for simultaneous detection of HPV-16/18 and other high-risk genotypes in cervical specimens.

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不同储存介质宫颈标本中Alinity m型HPV和cobas型HPV检测的比较

目的评估不同采集/储存方案(ThinPrep、SurePath、Cervicollect)宫颈标本中高危HPV (HR-HPV)检测与Alinity检测的一致性，并评估Alinity m HR HPV检测(Alinity)与cobas®4800 HPV检测(cobas)宫颈细胞标本中高危HPV检测的一致性。方法从一家妇女保健诊所的560名妇女中采集标本。从每名妇女身上获得两份标本，使用三种收集装置中的两种组合，并通过两种分析对等分进行测试。结果ThinPrep与SurePath样品的盐度一致性为93.9%，Kappa = 0.89 (263/280);在细胞学处理前和细胞学处理后，ThinPrep和SurePath分别为97.5%，Kappa = 0.95(347/356)和92.9%，Kappa = 0.85(104/112)。Cervi-Collect标本与ThinPrep标本的一致性为94.6%，Kappa = 0.89(265/280)。与cobas相比，Alinity的一致性为94.3%，Kappa = 0.88 (395/419); Alinity的一致性为91.8%，Kappa = 0.82(257/280)。Alinity和cobas检测到基因型16/18和其他高危型HPV的比例相似，并与细胞学分级显示相似的相关性。结论与cobas相比，Alinity在ThinPrep和SurePath获得的宫颈标本中检测HPV的效果相同。与其他收集方法相比，Cervi-Collect设备性能良好。Alinity是同时检测宫颈标本中HPV-16/18和其他高危基因型的可靠方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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