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实时聚合酶链反应检测临床样本中[具体检测物未给出]的诊断准确性:一项系统评价和荟萃分析。

Diagnostic accuracy of real-time polymerase chain reaction assay for the detection of in clinical samples: A systematic review and meta-analysis.

作者信息

Babafemi Emmanuel O, Cherian Benny P, Rahman Khalid, Mogoko Gilbert M, Abiola Oluwatoyin O

机构信息

Department of Pharmacy and Biomolecular Sciences, Faculty of Science, Liverpool John Moores University, Liverpool, United Kingdom.

Department of Microbiology, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.

出版信息

Afr J Lab Med. 2025 Apr 16;14(1):2522. doi: 10.4102/ajlm.v14i1.2522. eCollection 2025.

DOI:10.4102/ajlm.v14i1.2522
PMID:40356692
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12067014/
Abstract

BACKGROUND

Vaginal trichomoniasis is a highly prevalent parasitic infection associated with HIV acquisition and preterm birth. The 'gold standard' for its diagnosis requires 3-7 days to detect by culture. Rapid and accurate diagnosis, such as by nucleic acid amplification testing, is key to manage the disease, and control and prevent its transmission.

AIM

This review aimed to assess the overall accuracy of real-time polymerase chain reaction (RT-PCR)-based assays, for routine diagnosis of in clinical vaginal samples from women with symptomatic/asymptomatic trichomoniasis, using Trichomonads culture as the gold standard.

METHODS

MEDLINE, PubMed, EMBASE, and other sources were used to search for included studies published between 01 January 1995 and 31 July 2023. The search terms 'real-time polymerase chain reaction', 'real-time', 'polymerase chain reaction', '', 'trichomonas', 'vaginalis', 'humans', 'rt pcr', 'nucleic acid amplification test', 'NAAT', 'trichomonad culture', 'women' were included. Summary estimates were calculated for the overall accuracy of the assay compared to Trichomonads culture as the reference standard. Meta-analysis was conducted using a bivariate meta-regression model.

RESULTS

Twenty-seven eligible studies met our inclusion criteria: sensitivity 99% (95% confidence interval [CI] 99-100), specificity 100% (95% CI 100-100), positive likelihood ratio 350.67 (167.42-734.49), negative likelihood ratio 0.02 (0.01-0.03), diagnostic odds ratio 23 064.05 (95% CI 8532.13-62 346.77), and area under receiver operating characteristics curve 0.99. There was significant heterogeneity in sensitivity and specificity ( < 0.001).

CONCLUSION

Our results suggested that RT-PCR assays could be useful for the diagnosis of vaginal trichomoniasis with high sensitivity and specificity.

WHAT THIS STUDY ADDS

This article provides a comprehensive review of the effectiveness of RT-PCR assays for the diagnosis of trichomoniasis with high sensitivity and specificity in comparison to other methods in clinical laboratory practice. The goal is to present awareness/evidence that this assay is more accurate and rapid than other techniques.

摘要

背景

阴道毛滴虫病是一种高度流行的寄生虫感染,与感染艾滋病毒及早产有关。其诊断的“金标准”是通过培养检测,需要3 - 7天。快速准确的诊断,如通过核酸扩增检测,是管理该疾病以及控制和预防其传播的关键。

目的

本综述旨在以滴虫培养作为金标准,评估基于实时聚合酶链反应(RT-PCR)的检测方法对有症状/无症状滴虫病女性临床阴道样本进行常规诊断的总体准确性。

方法

使用MEDLINE、PubMed、EMBASE及其他来源检索1995年1月1日至2023年7月31日期间发表的纳入研究。检索词包括“实时聚合酶链反应”“实时”“聚合酶链反应”“滴虫”“阴道毛滴虫”“人类”“rt pcr”“核酸扩增检测”“NAAT”“滴虫培养”“女性”。计算该检测方法与作为参考标准的滴虫培养相比的总体准确性的汇总估计值。使用双变量元回归模型进行荟萃分析。

结果

27项符合条件的研究满足我们的纳入标准:敏感性99%(95%置信区间[CI]99 - 100),特异性100%(95%CI 100 - 100),阳性似然比350.67(167.42 - 734.49),阴性似然比0.02(0.01 - 0.03),诊断比值比23064.05(95%CI 8532.13 - 62346.77),以及受试者操作特征曲线下面积0.99。敏感性和特异性存在显著异质性(<0.001)。

结论

我们的结果表明,RT-PCR检测方法可用于诊断阴道毛滴虫病,具有高敏感性和特异性。

本研究的新增内容

本文全面综述了RT-PCR检测方法在临床实验室实践中与其他方法相比,对滴虫病诊断具有高敏感性和特异性的有效性。目的是提高人们对该检测方法比其他技术更准确、快速的认识/提供相关证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d8/12067014/3c11c7f99623/AJLM-14-2522-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d8/12067014/a8f3eb078ed2/AJLM-14-2522-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d8/12067014/3c11c7f99623/AJLM-14-2522-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d8/12067014/a8f3eb078ed2/AJLM-14-2522-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d8/12067014/3c11c7f99623/AJLM-14-2522-g002.jpg

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Simultaneous real-time PCR detection of nine prevalent sexually transmitted infections using a predesigned double-quenched TaqMan probe panel.使用预设计的双荧光淬灭 TaqMan 探针组实时 PCR 同时检测九种常见性传播感染。
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