Molecular assays for the initial diagnosis of tuberculosis in a low-prevalence setting: A comparative study

IF 2.6 4区医学 Q3 INFECTIOUS DISEASES

Enfermedades infecciosas y microbiologia clinica Pub Date : 2025-05-01 DOI:10.1016/j.eimc.2024.11.013

Ana Fernández-Blázquez , Álvaro Leal-Negredo , Christian Sabater-Cabrera , Miguel Arias-Guillén , José-María García-García , Juan José Palacios Gutiérrez

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Abstract

Introduction

The WHO's End TB Strategy promotes using rapid molecular assays as initial diagnosis to reduce tuberculosis globally. This prospective study assessed commercial molecular platforms’ effectiveness in diagnosing or ruling out tuberculosis (TB) in a low-prevalence setting.

Methods

One hundred clinical samples (80 respiratory/20 non-respiratory) were included among all samples routinely received in a mycobacterial laboratory. Five real-time polymerase-chain-reaction (RT-PCR) assays (Xpert-MTB/Rif-Ultra, BDMAX-MDR-TB, RealTime-MTB, FluoroType-MTBDR, Anyplex-MTB/NTM) were characterized and compared through blinded-parallel analysis. Sensitivity, specificity, likelihood ratios, and Cohen's Kappa were calculated to assess the accuracy and agreement of RT-PCR results with culture.

Results

Sensitivity ranged 88.89–100%, improving initial screening by 30–40%. Specificity was 96.70–98.98%. RT-PCR showed excellent discriminatory power, as TB patients were 26.9–91.0 times more likely to test positive. Cohen's Kappa showed substantial to excellent concordance (0.78–0.94).

Conclusion

RT-PCR improves TB initial diagnosis, offering tailored solutions for diverse laboratories, revolutionizing control strategies with its operational flexibility.

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分子检测在低患病率环境下对肺结核的初步诊断：一项比较研究

世卫组织终止结核病战略促进使用快速分子检测作为初始诊断，以在全球减少结核病。这项前瞻性研究评估了商业分子平台在低患病率环境下诊断或排除结核病（TB）的有效性。方法选取分枝杆菌实验室常规采集的临床标本100份，其中呼吸道标本80份/非呼吸道标本20份。通过盲法平行分析，对5种实时聚合酶链反应（RT-PCR）检测方法（expert - mtb /Rif-Ultra、BDMAX-MDR-TB、RealTime-MTB、fluorotype - mtb、Anyplex-MTB/NTM）进行了表征和比较。计算敏感性、特异性、似然比和Cohen’s Kappa，以评估RT-PCR结果与培养的准确性和一致性。结果灵敏度为88.89 ~ 100%，较初筛提高30 ~ 40%。特异性为96.70 ~ 98.98%。RT-PCR显示出出色的区分能力，结核病患者的检测阳性可能性是26.9-91.0倍。Cohen’s Kappa显示相当至极好的一致性（0.78-0.94）。结论rt - pcr提高了结核病的早期诊断，为不同实验室提供了量身定制的解决方案，以其操作灵活性彻底改变了控制策略。

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

Enfermedades infecciosas y microbiologia clinica 医学-传染病学

CiteScore

2.10

自引率

8.00%

发文量

194

审稿时长

29 days

期刊介绍： Hoy está universalmente reconocida la renovada y creciente importancia de la patología infecciosa: aparición de nuevos agentes patógenos, de cepas resistentes, de procesos con expresión clínica hasta ahora desconocida, de cuadros de una gran complejidad. Paralelamente, la Microbiología y la Infectología Clínicas han experimentado un gran desarrollo como respuesta al reto planteado por la actual patología infecciosa. Enfermedades Infecciosas y Microbiología Clínica es la Publicación Oficial de la Sociedad Española SEIMC. Cumple con la garantía científica de esta Sociedad, la doble función de difundir trabajos de investigación, tanto clínicos como microbiológicos, referidos a la patología infecciosa, y contribuye a la formación continuada de los interesados en aquella patología mediante artículos orientados a ese fin y elaborados por autores de la mayor calificación invitados por la revista.