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在中国进行Ureaplasma urealyticum分子检测的外部质量评估

Yanxi Han¹, Jian Jiang¹, Yu Ma¹

¹National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, P. R. China; National Center for Clinical Laboratories, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, P. R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, P. R. China.

Clinica chimica acta; international journal of clinical chemistry

|March 10, 2024

概括

这项研究评估了实验室检测的分子Ureaplasma urealyticum (UU). 虽然大多数实验室都能准确地检测出高度和中等度的UU,但在低度的情况下,性能出现了不稳定,这表明需要对测试进行优化.

科学领域:

临床微生物学临床微生物学
分子诊断学分子诊断
传染性疾病传染性疾病

背景情况:

在诊断生殖泌尿道感染时,检测尿 (Ureaplasma urealyticum,UU) 非常重要.
外部质量评估 (EQA) 计划评估实验室测试能力.
评估基于DNA和基于RNA的核酸放大试验 (NAAT) 对临床环境很重要.

研究的目的:

评估临床实验室在分子UU检测方面的表现.
为了比较基于DNA和基于RNA的NAAT对UU的有效性.
确定UU诊断试验需要改进的领域.

主要方法:

国家临床实验室中心 (NCCL) 进行了一项试点EQA计划.
使用了一个由12个冷解样本组成的小组,具有不同的UU度 (高,中等,低) 和负对照.
分析了来自338个参与实验室的360个结果,以确定其定性准确性.

主要成果:

96.11%的结果和95.86%的实验室被认为是合格的.
高度和中度的UU度显示出高的阳性百分比协议 (PPA) (≥97.5%).
在这项研究中,低UU度显示出可变的PPA (51.94%-86.94%),基于RNA的NAAT显示出更高的PPA.

结论:

大多数UU检测测定与其检测极限 (LOD) 保持一致.
实验室可靠地检测出高度和中度的UU.
对于低UU度的分析性能需要显著改进和优化.

关键词:

分析性表现分析性表现基于DNA的NAAT研究结果外部质量评估外部质量评估积极的百分比协议协议.基于RNA的NAAT是基于RNA的NAAT.

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