Evaluation of YD MolecuTech Real HPV Assay in Comparison with Roche Cobas HPV Assay and BD Onclarity HPV Assay for Detection of HPV Infection.

IF 1.1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Annals of clinical and laboratory science Pub Date : 2024-03-01

Chang-Hun Park, Chang-Woon Kim, Hyoun Wook Lee, Min-Jung Kwon

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Abstract

Objective: Human papillomavirus (HPV) is a double-stranded DNA virus that belongs to the papillomavirus family. High-risk (HR) genotypes of HPV are associated with cervical cancer. The combination of molecular HPV testing and cytology results in an increased detection of high-grade cervical lesions. This study compares the performance of a newly developed MolecuTech Real HPV 16/18/HR assay to that of the cobas HPV assay and Onclarity HPV Assay in Korea.

Methods: A SurePath liquid-based cytology device (BD diagnostics, NC, USA) was used to prospectively collect cervical swab specimens. Onclarity HPV Assay (Onclarity; BD diagnostics), Cobas 4800 HPV Test (Cobas; Roche, Rotkreuz, Switzerland), and MolecuTech Real HPV 16/18/HR (MolecuTech; YD, Yongin, Korea) were performed to detect HPV genotypes.

Results: Of the 438 cervical specimens, 13.7% showed the HR-HPV genotype. The concordance rates between Onclarity and MolecuTech, cobas and MolecuTech, and Onclarity and Cobas were 94.9% (kappa=0.754), 95.7% (kappa=0.768), and 95.5% (kappa=0.791), respectively. Moreover, no statistically significant differences in HPV genotyping results were observed in the cytology-positive specimens.

Conclusions: The MolecuTech Real HPV 16/18/HR assay showed good agreement in the detection of HR HPV genotypes, and similar analytical performance for the detection of HR HPV genotypes in samples with abnormal cytological findings.

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评估 YD MolecuTech Real HPV 检测法与罗氏 Cobas HPV 检测法和 BD Onclarity HPV 检测法在检测 HPV 感染方面的比较。

目的：人类乳头瘤病毒（HPV）是一种双链 DNA 病毒，属于乳头瘤病毒家族。HPV的高危（HR）基因型与宫颈癌有关。分子 HPV 检测与细胞学检查相结合，可提高高级别宫颈病变的检出率。本研究比较了韩国新开发的 MolecuTech Real HPV 16/18/HR 检测法与 cobas HPV 检测法和 Onclarity HPV 检测法的性能：方法：使用 SurePath 液基细胞学设备（美国北卡罗来纳州 BD 诊断公司）前瞻性地收集宫颈拭子标本。方法：使用 SurePath 液基细胞学设备（BD 诊断公司，美国北卡罗来纳州）前瞻性地收集宫颈拭子标本，并使用 Onclarity HPV Assay（Onclarity；BD 诊断公司）、Cobas 4800 HPV Test（Cobas；罗氏，瑞士罗特克鲁兹）和 MolecuTech Real HPV 16/18/HR（MolecuTech；YD，韩国龙仁市）检测 HPV 基因型：结果：在 438 份宫颈标本中，13.7% 显示 HR-HPV 基因型。Onclarity与MolecuTech、cobas与MolecuTech、Onclarity与Cobas之间的吻合率分别为94.9%（kappa=0.754）、95.7%（kappa=0.768）和95.5%（kappa=0.791）。此外，在细胞学阳性标本中，HPV 基因分型结果无统计学差异：结论：MolecuTech Real HPV 16/18/HR检测方法在检测HR HPV基因型方面表现出良好的一致性，在检测细胞学结果异常样本中的HR HPV基因型方面具有相似的分析性能。

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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来源期刊

Annals of clinical and laboratory science 医学-医学实验技术

CiteScore

1.60

自引率

0.00%

发文量

112

审稿时长

6-12 weeks

期刊介绍： The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.