评价 YD MolecuTech Real HPV 检测与罗氏 Cobas HPV 检测和 BD Onclarity HPV 检测在 HPV 感染检测中的应用比较。

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

机构信息

Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.

Department of Laboratory Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Korea.

出版信息

Ann Clin Lab Sci. 2024 Mar;54(2):239-245.

PMID:38802145

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.

摘要

目的

人乳头瘤病毒（HPV）是一种双链 DNA 病毒，属于乳头瘤病毒科。高危（HR）型 HPV 与宫颈癌有关。HPV 分子检测与细胞学结果相结合，可提高高级别宫颈病变的检出率。本研究比较了新开发的 MolecuTech Real HPV 16/18/HR 检测与 cobas HPV 检测和 Onclarity HPV 检测在韩国的性能。

方法

使用 SurePath 液基细胞学设备（BD diagnostics，NC，美国）前瞻性收集宫颈拭子标本。进行 Onclarity HPV 检测（Onclarity；BD diagnostics）、Cobas 4800 HPV 检测（Cobas；罗氏，瑞士罗特克）和 MolecuTech Real HPV 16/18/HR（MolecuTech；YD，韩国 Yongin）以检测 HPV 基因型。

结果

在 438 例宫颈标本中，13.7%显示 HR-HPV 基因型。Onclarity 和 MolecuTech、cobas 和 MolecuTech、Onclarity 和 Cobas 的一致性率分别为 94.9%（kappa=0.754）、95.7%（kappa=0.768）和 95.5%（kappa=0.791）。此外，细胞学阳性标本中 HPV 基因分型结果无统计学差异。