Evaluation of Loopamp™MTBC detection kit for diagnosis of pulmonary tuberculosis at a peripheral laboratory in a high burden setting

Publication date: Available online 21 November 2017
Source:Diagnostic Microbiology and Infectious Disease
Author(s): Van Anh Thi Nguyen, Hung Van Nguyen, Thuong Van Dinh, Ha Hoang Du, Chinh Nhu Do, Guy B. Marks, Nhung Viet Nguyen
The Loopamp™MTBC detection kit (TB-LAMP) was designed to replace the sputum smear microscopy for the diagnosis of pulmonary tuberculosis. We evaluated its performance at a peripheral laboratory in Vietnam. The sensitivity of TB-LAMP was 45.5% [28.1% - 63.6%], which was equal to three-sputum smear microscopy but lower than that of Xpert MTB/RIF (87.8% [71.8% - 96.6%]). In patients with culture-confirmed TB, sensitivity was 80% [51.9% - 95.7%] in smear-positive and 16.7% [3.5% - 41.4%] in smear-negative cases. The specificity of TB-LAMP was 95.1% (92.7% - 96.9%), which was lower than that of smear microscopy (98.9% [97.5% - 99.7%]) and Xpert MTB/RIF (99.3% [98.1% - 99.9%]) (p<0.05). The probability of TB detection by TB-LAMP was more influenced by sample quality and viscosity than were smear microscopy, Xpert MTB/RIF and culture. The present data do not support the use of TB-LAMP as a replacement test for smear microscopy in peripheral laboratories.



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