评估 GeneXpert 在推定肺结核和推定耐药肺结核患者中检测结核分枝杆菌和耐利福平结核病的诊断准确性

IF 2.1 Q3 MICROBIOLOGY

Microbiology Research Pub Date : 2023-12-22 DOI:10.3390/microbiolres15010006

Venkateswari Ramachandra, Usharani Brammacharry, Aaina Muralidhar, Anbazhagi Muthukumar, Revathi Mani, M. Muthaiah, Govindarajan Soundappan, Asha Frederick

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引用次数: 0

摘要

GeneXpert MTB/RIF 是一种快速分子诊断工具，能够同时检测结核分枝杆菌和利福平耐药性。本研究旨在评估 GeneXpert MTB/RIF 检测法在检测肺结核和肺外结核病方面的诊断精确度，并评估其在检测利福平耐药性方面的性能。在 37,695 份样本中，7156 份（18.98%）结核菌阳性，509 份（7.11%）对利福平耐药。GeneXpert MTB/RIF 检测法对肺结核的灵敏度、特异性、阳性预测值、阴性预测值、疾病流行率和准确性分别为 99.87% (95%CI: 99. 75-99.94), 99.75-99.94）、99.92%（95%CI：99.88-99.95）、99.71%（95%CI：99.54-99.82）、99.97%（95%CI：99.93-99.98）、21.38%（95%CI：20.92-21.86）和 99.91%（95%CI：99.87-99.94）。对于肺外结核病，GeneXpert MTB/RIF 检测的敏感性、特异性、PPV、NPV、疾病流行率和准确性分别为 99.45%（95%CI：98.73-99.82）、99.84%（95%CI：99.87-99.94）和 99.91%（95%CI：99.87-99.94）。82）、99.84%（95%CI：99.73-99.92）、98.70%（95%CI：97.73-99.25）、99.93%（95%CI：99.84-99.97）、10.64%（95%CI：9.99-11.31）和 99.80%（95%CI：99.68-99.88）。尽管 GeneXpert MTB/RIF 检测结核病和利福平耐药性的灵敏度很高，但在涂片结果阴性的患者中，20.5% 的病例和 54.9% 的耐多药结核病高危患者的检测结果存在矛盾。在46%的耐氟喹诺酮病例中，16.56%（26/157）为耐多药结核病分离株，4.02%（20/498）为耐异烟肼结核病分离株，这种特征性分布导致约17.2%的耐氟喹诺酮事件和MDR结核病分离株中的相关标记物gyr-A突变。此外，我们的研究还表明，耐利福平和耐异烟肼结核病患者对氟喹诺酮类药物耐药性的增加会危及新批准的 MDR-TB 治疗方案的成功。

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Assess the Diagnostic Accuracy of GeneXpert to Detect Mycobacterium tuberculosis and Rifampicin-Resistant Tuberculosis among Presumptive Tuberculosis and Presumptive Drug Resistant Tuberculosis Patients

GeneXpert MTB/RIF is a rapid molecular diagnostic tool capable of simultaneously detecting Mycobacterium tuberculosis and rifampicin resistance. This study aimed to assess the diagnostic precision of GeneXpert MTB/RIF assay to detect pulmonary and extrapulmonary tuberculosis and evaluate the performance for detecting of rifampicin resistance. Of 37,695 samples, 7156 (18.98%) were tuberculosis-positive, and 509 (7.11%) were rifampicin-resistant. The sensitivity, specificity, positive predictive value, negative predictive value, disease prevalence, and accuracy of the GeneXpert MTB/RIF assay for pulmonary tuberculosis were 99.87% (95%CI: 99.75–99.94), 99.92% (95%CI: 99.88–99.95), 99.71% (95%CI: 99.54–99.82), 99.97% (95%CI: 99.93–99.98), 21.38% (95%CI: 20.92–21.86), and 99.91% (95%CI: 99.87–99.94), respectively. For extrapulmonary tuberculosis, the sensitivity, specificity, PPV, NPV, disease prevalence, and accuracy of GeneXpert MTB/RIF assay accounted for 99.45% (95%CI: 98.73–99.82), 99.84% (95%CI: 99.73–99.92), 98.70% (95%CI: 97.73–99.25), 99.93% (95%CI: 99.84–99.97), 10.64% (95%CI: 9.99–11.31), and 99.80% (95%CI: 99.68–99.88), respectively. Despite its high sensitivity for detecting tuberculosis and rifampicin resistance, GeneXpert MTB/RIF had contradictory results for 20.5% of cases among patients with smear-negative results and 54.9% of cases among patients with a high risk of multidrug-resistant tuberculosis. Of 46% fluoroquinolone-resistant cases, 16.56% (26/157) were multidrug-resistant tuberculosis isolates, and 4.02% (20/498) were isoniazid-resistant, a characteristic distribution leading to about 17.2% of fluoroquinolone-resistance events and relevant marker gyr-A mutations in MDR tuberculosis isolates. Further, our study indicated that increased fluoroquinolone resistance among rifampicin-resistant and isoniazid-resistant tuberculosis endangers the success of newly endorsed MDR-TB regimens.

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来源期刊

Microbiology Research MICROBIOLOGY-

CiteScore

1.90

自引率

6.70%

发文量

审稿时长

10 weeks

期刊介绍： Microbiology Research is an international, online-only, open access peer-reviewed journal which publishes original research, review articles, editorials, perspectives, case reports and brief reports to benefit researchers, microbiologists, physicians, veterinarians. Microbiology Research publishes ‘Clinic’ and ‘Research’ papers divided into two different skill and proficiency levels: ‘Junior’ and ‘Professional’. The aim of this four quadrant grid is to encourage younger researchers, physicians and veterinarians to submit their results even if their studies encompass just a limited set of observations or rely on basic statistical approach, yet upholding the customary sound approach of every scientific article.