利孚、延能、达瑞和 Cobas 4800 检测用于高危型人乳头瘤病毒筛查的一致性评价。
Consistency evaluation of Liferiver, Yaneng, Darui, and the Cobas 4800 test for high-risk human papillomavirus screening.
机构信息
Medical Laboratory of the Third Affiliated Hospital of ShenZhen University, Shenzhen, China.
Anhui University of Science and Technology, Huainan, China.
出版信息
J Clin Lab Anal. 2020 Dec;34(12):e23536. doi: 10.1002/jcla.23536. Epub 2020 Aug 19.
BACKGROUND
In recent years, several high-risk human papillomavirus (HR-HPV) tests have been developed. The assay capabilities need to be systematically reviewed. Here, we compared the clinical sample performance of three novel HR-HPV assays (Liferiver, Yaneng, and Darui) based on different platforms with the widely adopted cobas4800 test.
METHODS
A total of 346 cervical swabs from women who were screened for cervical cancer were analyzed for the presence of 14 HR-HPV genotypes. The distinction between the four assays was investigated by the genotyping and direct sequencing.
RESULTS
The positive rates of the four assays ranged from 61.56% to 64.16%. The overall concordance was 88.15%. The Yaneng assays displayed the best sensitivity (100%) and specificity (98.43%). The sensitivity (98.17%) and specificity (98.43%) of the Darui assay were superior to those of the cobas4800 test (97.72% and 93.70%, respectively). The Liferiver assay displayed comparable sensitivity with the cobas4800 test (95.89% and 97.72%, respectively). The specificity of the cobas4800 was lower than that of the Liferiver assay (93.70% vs. 97.64%).
CONCLUSIONS
The three novel HR-HPV assays displayed good agreement with the cobas4800 test. The analytical performance of all four fulfilled the requirements of sensitivity and specificity for HR-HPV detection.
背景
近年来，已经开发出了几种高危型人乳头瘤病毒（HR-HPV）检测方法。需要系统地评估这些检测方法的性能。在此，我们基于不同的平台，将三种新型 HR-HPV 检测方法（Liferiver、Yaneng 和 Darui）与广泛应用的 cobas4800 检测方法进行了临床样本性能比较。
方法
对 346 例接受宫颈癌筛查的女性宫颈拭子进行了 14 种 HR-HPV 基因型检测。通过基因分型和直接测序来研究四种检测方法之间的差异。
结果
四种检测方法的阳性率在 61.56%至 64.16%之间。总体一致性为 88.15%。Yaneng 检测方法的灵敏度（100%）和特异性（98.43%）最高。Darui 检测方法的灵敏度（98.17%）和特异性（98.43%）优于 cobas4800 检测方法（分别为 97.72%和 93.70%）。Liferiver 检测方法的灵敏度与 cobas4800 检测方法相当（分别为 95.89%和 97.72%）。 cobas4800 检测方法的特异性低于 Liferiver 检测方法（93.70%比 97.64%）。
结论
三种新型 HR-HPV 检测方法与 cobas4800 检测方法具有良好的一致性。四种检测方法的分析性能均满足 HR-HPV 检测的灵敏度和特异性要求。
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