国际标准期刊号: 2471-9315
Neha Sharma, Paras Singh, Monika Malik, Sangeeta Sharma, Khalid U. Khayyam, Ravindra Kumar Dewan, Neeraj Kumar
Tuberculosis (TB) is known to cause the highest number of infection related deaths worldwide. In 2016, WHO approved TB-LAMP (Loop-Mediated Isothermal Amplification) assay as a replacement for smear microscopy for the diagnosis of PTB in adult TB suspects. However, more epidemiological research should be conducted to support the deployment of the TB-LAMP program in peripheral level healthcare settings. This study analyzed the diagnostic efficacy of rapid and inexpensive TB-LAMP assay for the diagnosis of PTB. TB-LAMP assay displayed 1.8-fold (minimum 49.2%) higher positivity rates than the smear microscopy test (maximum 29.6%). In comparison to the composite reference standard, TB-LAMP assay was observed to be 84.3% sensitive and 96.8% specific for the diagnosis of PTB. The positive predictive value and negative predictive value of the TB-LAMP assay were 88.2 (95%CI: 77.3-94.3) and 95.6 (95% CI: 94.2-96.7), respectively. Therefore, TB-LAMP assay should be an essential point of care test for the diagnosis of PTB in adults, especially in resource limited and rural healthcare settings of TB endemic regions.