Evaluation of the diagnostic efficacy of CRISPR-based tuberculosis diagnostics, GeneXpert MTB/RIF, and innowave DX MTB/RIF across diverse tuberculosis patient populations

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-08-11 DOI:10.1016/j.diagmicrobio.2025.117059

Xike Zhou , Yan Peng , Mohan Huang , Tian He , Junjie Lu , Hao Pei , Fang Wang

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引用次数: 0

Abstract

Purpose

This study aimed to evaluate the diagnostic efficacy of CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-based tuberculosis (TB) diagnostics, GeneXpert MTB/RIF, and Innowave DX MTB/RIF assays across diverse tuberculosis patient populations.

Methods

A case-control study was conducted on hospitalized patients with suspected tuberculosis from June 2023 to September 2023. The study population was stratified by age, gender, and comorbidity status. Participants underwent testing with CRISPR-based diagnostics, GeneXpert MTB/RIF, and Innowave DX MTB/RIF assays. Mycobacterial culture served as the reference standard. Sensitivity, specificity, accuracy, false positive rate, and false negative rate were calculated for each test across strata. Diagnostic performance was compared using Chi-square tests.

Results

Our study included 187 patients, with 114 testing positive for TB. CRISPR diagnostics exhibited the highest sensitivity (0.660) across all tests, while GeneXpert MTB/RIF demonstrated perfect specificity (0.986). Innowave DX MTB/RIF assays showed sensitivity and specificity of 0.576 and 0.984. Notably, CRISPR diagnostics outperformed other tests in accuracy (0.798) among elderly patients, while maintaining robust diagnostic efficacy across gender and comorbidity groups. Statistical analysis indicated no significant differences in sensitivity and specificity among age groups (all P > 0.8), nor any significant effect of gender or comorbid conditions on diagnostic performance (all P > 0.7).

Conclusion

CRISPR-based diagnostics, GeneXpert MTB/RIF, and Innowave DX MTB/RIF assays demonstrate high diagnostic utility across diverse TB patient populations. CRISPR diagnostics show promising sensitivity and accuracy, suggesting significant potential for TB diagnosis. Their performance remains consistent regardless of age, gender, or comorbidities, supporting broad clinical applicability.

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评估基于crispr的结核病诊断、GeneXpert MTB/RIF和innovave DX MTB/RIF在不同结核病患者群体中的诊断效果

本研究旨在评估基于CRISPR （Clustered Regularly Interspaced Short Palindromic Repeats）的结核病（TB）诊断方法、GeneXpert MTB/RIF和innovave DX MTB/RIF检测在不同结核病患者群体中的诊断效果。方法对2023年6月~ 2023年9月住院的疑似肺结核患者进行病例对照研究。研究人群按年龄、性别和合并症状况分层。参与者接受了基于crispr的诊断、GeneXpert MTB/RIF和innovave DX MTB/RIF检测。分枝杆菌培养物作为参考标准。计算各层各测试的灵敏度、特异性、准确性、假阳性率和假阴性率。采用卡方检验比较诊断性能。结果本研究纳入187例患者，其中114例结核检测呈阳性。CRISPR诊断在所有测试中表现出最高的灵敏度（0.660），而GeneXpert MTB/RIF表现出完美的特异性（0.986）。Innowave DX MTB/RIF检测的灵敏度和特异性分别为0.576和0.984。值得注意的是，CRISPR诊断在老年患者中的准确性优于其他测试（0.798），同时在性别和合病组中保持强大的诊断功效。统计学分析显示，各年龄组间敏感性和特异性无显著差异(P >；0.8)，性别或合并症对诊断表现没有显著影响(所有P >；0.7)。结论基于crispr的诊断、GeneXpert MTB/RIF和innovave DX MTB/RIF检测在不同的结核病患者群体中显示出很高的诊断效用。CRISPR诊断显示出良好的敏感性和准确性，表明在结核病诊断方面具有重大潜力。无论年龄、性别或合并症如何，它们的表现都是一致的，支持了广泛的临床适用性。

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

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.