<span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Background: </span></b></span><span><span><span style="font-family:&...<span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Background: </span></b></span><span><span><span style="font-family:""><span style="font-family:Verdana;">Due to the limitations of diagnosis by Xpert MTB/RIF assay, WHO suggests Loop</span><b><span style="font-family:Verdana;">—</span></b><span style="font-family:Verdana;">Mediated Isothermal Amplification (TB-LAMP) instead of sputum-smear microscopy for pulmonary TB diagnosis in patients. Dr. Thongchai Kaewphinit <i></span><i><span style="font-family:Verdana;">et al</span></i><span style="font-family:Verdana;"></i></span><i><span style="font-family:Verdana;">.</span></i><span style="font-family:Verdana;"> invented a fast TB detection kit called TB d-tect (LAMP-LFD assay). There was no clinical trial to estimate the performance of TB d-tect. </span><b><span style="font-family:Verdana;">Objective:</span></b><span style="font-family:Verdana;"> This study was aimed to find the performance of LFD assay and Xpert MTB/RIF ultra for pulmonary TB. </span><b><span style="font-family:Verdana;">Material</span></b> <b><span style="font-family:Verdana;">and</span></b> <b><span style="font-family:Verdana;">methods:</span></b><span style="font-family:Verdana;"> A cross-sectional study was conducted. Suggestive pulmonary TB patients were enrolled from June 2020-28 February 2021.</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">Respiratory specimen</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">s</span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;"> were collected from each patient and sent for AFB smear, LAMP-LFD assay, Xpert MTB/RIF ultra and culture TB. </span><b><span style="font-family:Verdana;">Result:</span></b><span style="font-family:Verdana;"> 139 patients with suspected pulmonary TB were enrolled.</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">51% of patients were diagnosed with pulmonary tuberculosis. Based on culture TB as a gold standard, the sensitivity and specificity of LAMP-LFD assay were 85.4% (95% CI:</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">70.8% - 94.4%) and 87.8% (95% CI:</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">79.6 - 93.5), respectively. The sensitivity and specificity of Xpert MTB/RIF ultra were 95.1% (95% CI: 83.5% - 99.4%) and 74.5% (95% CI: 64.7 - 82.8), respectively. According to ROC curve, it was found that the areas under the curve of LAMP-LFD assay and Xpert MTB/RIF ultra were 0.866 and 0.848, respectively (</span><span style="font-family:Verdana;">p</span><span style="font-family:Verdana;"> = 0.546). </span><b><span style="font-family:Verdana;">Conclusion</span></b><span style="font-family:Verdana;">: The diagnostic sensitivity and specificity of LAMP-LFD assay appeared to be comparable to those of Xpert MTB/RIF ultra. LAMP-LFD assay could be used in resource limiting laboratory.展开更多
文摘<span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Background: </span></b></span><span><span><span style="font-family:""><span style="font-family:Verdana;">Due to the limitations of diagnosis by Xpert MTB/RIF assay, WHO suggests Loop</span><b><span style="font-family:Verdana;">—</span></b><span style="font-family:Verdana;">Mediated Isothermal Amplification (TB-LAMP) instead of sputum-smear microscopy for pulmonary TB diagnosis in patients. Dr. Thongchai Kaewphinit <i></span><i><span style="font-family:Verdana;">et al</span></i><span style="font-family:Verdana;"></i></span><i><span style="font-family:Verdana;">.</span></i><span style="font-family:Verdana;"> invented a fast TB detection kit called TB d-tect (LAMP-LFD assay). There was no clinical trial to estimate the performance of TB d-tect. </span><b><span style="font-family:Verdana;">Objective:</span></b><span style="font-family:Verdana;"> This study was aimed to find the performance of LFD assay and Xpert MTB/RIF ultra for pulmonary TB. </span><b><span style="font-family:Verdana;">Material</span></b> <b><span style="font-family:Verdana;">and</span></b> <b><span style="font-family:Verdana;">methods:</span></b><span style="font-family:Verdana;"> A cross-sectional study was conducted. Suggestive pulmonary TB patients were enrolled from June 2020-28 February 2021.</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">Respiratory specimen</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">s</span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;"> were collected from each patient and sent for AFB smear, LAMP-LFD assay, Xpert MTB/RIF ultra and culture TB. </span><b><span style="font-family:Verdana;">Result:</span></b><span style="font-family:Verdana;"> 139 patients with suspected pulmonary TB were enrolled.</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">51% of patients were diagnosed with pulmonary tuberculosis. Based on culture TB as a gold standard, the sensitivity and specificity of LAMP-LFD assay were 85.4% (95% CI:</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">70.8% - 94.4%) and 87.8% (95% CI:</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">79.6 - 93.5), respectively. The sensitivity and specificity of Xpert MTB/RIF ultra were 95.1% (95% CI: 83.5% - 99.4%) and 74.5% (95% CI: 64.7 - 82.8), respectively. According to ROC curve, it was found that the areas under the curve of LAMP-LFD assay and Xpert MTB/RIF ultra were 0.866 and 0.848, respectively (</span><span style="font-family:Verdana;">p</span><span style="font-family:Verdana;"> = 0.546). </span><b><span style="font-family:Verdana;">Conclusion</span></b><span style="font-family:Verdana;">: The diagnostic sensitivity and specificity of LAMP-LFD assay appeared to be comparable to those of Xpert MTB/RIF ultra. LAMP-LFD assay could be used in resource limiting laboratory.
