Diagnostic accuracy of truenat MTB plus for the detection of pulmonary and extrapulmonary tuberculosis

IF 1.4 4区 医学 Q4 IMMUNOLOGY
Reena Anie Jose , Leeberk Raja Inbaraj , Ria Catherine Vincent , Adhin Baskar , Renu Mathew
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引用次数: 0

Abstract

Background

The diagnosis of Tuberculosis (TB) has been a challenge till the advent of rapid molecular diagnostic tests. The traditional diagnostic tests have its own limitations with regard to its performance or the turnaround time. Truenat MTB Plus assay, a battery-operated molecular assay developed in India has been introduced for its use in pulmonary TB (PTB). However, the diagnostic accuracy of the assay is not well studied in comparison with Mycobacterial culture, especially for extrapulmonary TB (EPTB).

Aim

We aimed at evaluating the diagnostic accuracy of Truenat MTB Plus assay for both PTB and EPTB comparing with culture for adult population.

Methods

The specimens from presumptive PTB and EPTB patients were processed for Truenat MTB Plus assay, solid or liquid culture and AFB staining. The electronic data of all the specimen reports collected retrospectively were analysed for the sensitivity and specificity.

Results

Out of the 736 samples which had valid culture reports, 364 (49.4 %) were respiratory and 372 (50.6 %) were extrapulmonary specimens. The test positivity rate for smear microscopy, Truenat MTB Plus assay and culture was 3.7 % (27), 8.2 % (60), 7.1 % (52) respectively. Of the 60 Truenat MTB Plus positive patients with TB, 33 (55 %) were PTB and 27 (45 %) were EPTB. We estimated overall sensitivity and specificity of Truenat MTB Plus as 90 % (95 % CI: 73.4–97.8) and 98. 2 (95 % CI:96–99.3) respectively for the detection of PTB. The overall sensitivity and specificity for EPTB was 81.8 % (95 % CI: 59.7–94.8) and 97.4 % (95 % CI: 95.1–98.8) respectively.

Conclusions

Truenat MTB Plus assay has comparable diagnostic accuracy with other molecular assays. The Truenat MTB Plus assay can be used for the diagnosis of PTB and EPTB, especially in resource limited settings.

truenat MTB plus 检测肺部和肺外结核病的诊断准确性。
背景:在快速分子诊断测试出现之前,结核病(TB)的诊断一直是个难题。传统的诊断测试在性能或周转时间方面有其自身的局限性。Truenat MTB Plus 检测法是印度开发的一种电池驱动分子检测法,已被用于肺结核(PTB)的检测。目的:我们旨在评估 Truenat MTB Plus 检测法与培养法相比对成人肺结核和肺结核的诊断准确性:对推定为 PTB 和 EPTB 患者的标本进行 Truenat MTB Plus 检测、固体或液体培养和 AFB 染色。对回顾性收集的所有标本报告的电子数据进行灵敏度和特异性分析:在 736 份有有效培养报告的样本中,364 份(49.4%)为呼吸道样本,372 份(50.6%)为肺外样本。涂片显微镜检查、Truenat MTB Plus 检测和培养的阳性率分别为 3.7 %(27 例)、8.2 %(60 例)和 7.1 %(52 例)。在 60 名 Truenat MTB Plus 检测呈阳性的肺结核患者中,33 人(55%)为 PTB,27 人(45%)为 EPTB。我们估计 Truenat MTB Plus 的总体灵敏度和特异性分别为 90 %(95 % CI:73.4-97.8)和 98.2(95 % CI:96-99.3)。对 EPTB 的总体敏感性和特异性分别为 81.8 %(95 % CI:59.7-94.8)和 97.4 %(95 % CI:95.1-98.8):Truenat MTB Plus 检测法的诊断准确性与其他分子检测法相当。Truenat MTB Plus 检测法可用于诊断 PTB 和 EPTB,尤其是在资源有限的情况下。
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来源期刊
CiteScore
2.20
自引率
0.00%
发文量
154
审稿时长
73 days
期刊介绍: Manuscripts of high standard in the form of original research, multicentric studies, meta analysis, are accepted. Current reports can be submitted as brief communications. Case reports must include review of current literature, clinical details, outcome and follow up. Letters to the editor must be a comment on or pertain to a manuscript already published in the IJMM or in relation to preliminary communication of a larger study. Review articles, Special Articles or Guest Editorials are accepted on invitation.
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