GeneXpert MTB/RIF 检测涂阴疑似结核病患者中 MTB 的诊断性能。
Diagnostic performance of GeneXpert MTB/RIF in detecting MTB in smear-negative presumptive TB patients.
机构信息
Department of Microbiology, Shi-Gan International College of Science and Technology, Kathmandu, Nepal.
Key Laboratory of Fujian-Taiwan Animal Pathogen Biology, College of Animal Sciences, Fujian Agriculture and Forestry University, Fuzhou, China.
出版信息
BMC Infect Dis. 2022 Apr 1;22(1):321. doi: 10.1186/s12879-022-07287-5.
BACKGROUND
Tuberculosis (TB) is a leading cause of morbidity and mortality worldwide. Control of TB is lingering by the lack of diagnostic tests that are simple, rapid, yet accurate. Thus, smear-negative pulmonary TB often misses the diagnosis. The study evaluated the performance of GeneXpert MTB/RIF assay for the detection of Mycobacterium tuberculosis (MTB).
METHODS
The study was carried out from June to December 2016 in Nepal Tuberculosis Center, Bhaktapur, Nepal. A total of 173 sputum samples were collected and processed by microscopy [Auramine-O staining and Ziehl-Neelsen (ZN) staining], followed by GeneXpert MTB/RIF assay and culture in Lowenstein-Jensen (LJ) medium.
RESULTS
Of 173 sputum samples, 162 (93.6%) were smear-negative. Of 162 smear-negative sputum samples, 35 (21.6%) were confirmed to have MTB by culture, and 31 (19.1%) by GeneXpert MTB/RIF assay. Of 31 GeneXpert-positive samples, 25 (80.6%) were susceptible, 4 (12.9%) were resistant, and 2 (6.45%) were intermediate to rifampicin. The sensitivity, specificity, positive predictive value, and negative predictive value of GeneXpert MTB/RIF assay for smear-negative sputum samples were 74.3%, 96.6%, 86.7%, and 92%, respectively. The GeneXpert MTB/RIF has a substantial diagnostic agreement of 90.91% with culture (Cohen's Kappa coefficient = 0.73).
CONCLUSION
The diagnostic performance of GeneXpert MTB/RIF assay was almost on par with culture, and thus can be relied upon for MTB detection in smear-negative sputum samples.
背景
结核病（TB）是全球发病率和死亡率的主要原因。控制结核病的进展受到缺乏简便、快速且准确的诊断测试的阻碍。因此，痰涂片阴性的肺结核经常被漏诊。本研究评估了 GeneXpert MTB/RIF 检测法对结核分枝杆菌（MTB）的检测性能。
方法
该研究于 2016 年 6 月至 12 月在尼泊尔巴克拉普尔的尼泊尔结核病中心进行。共采集了 173 份痰标本，通过显微镜检查（金胺-吖啶橙染色和 Ziehl-Neelsen 染色）、GeneXpert MTB/RIF 检测法和 Lowenstein-Jensen（LJ）培养基培养进行处理。
结果
173 份痰标本中，162 份（93.6%）为痰涂片阴性。在 162 份痰涂片阴性的标本中，35 份（21.6%）通过培养确认存在 MTB，31 份（19.1%）通过 GeneXpert MTB/RIF 检测法确认。在 31 份 GeneXpert 阳性样本中，25 份（80.6%）对利福平敏感，4 份（12.9%）耐药，2 份（6.45%）对利福平中介。GeneXpert MTB/RIF 检测法对痰涂片阴性标本的敏感性、特异性、阳性预测值和阴性预测值分别为 74.3%、96.6%、86.7%和 92%。GeneXpert MTB/RIF 与培养法的诊断一致性较高（90.91%，Cohen's Kappa 系数=0.73）。
结论
GeneXpert MTB/RIF 检测法的诊断性能与培养法相当，因此可依赖该法检测痰涂片阴性的标本中的 MTB。
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