Abstract
According to WHO, the rates of smear-negative and extra-pulmonary pulmonary tuberculosis are increasing in high prevalence HIV epidemic areas. Delays in diagnosis of tuberculosis can lead to large excess of mortality. It is extremely important to provide a strong diagnosis tool of tuberculosis if we want to reduce mortality due particularly to TB co-infection in HIV infected people in low-income countries such as Togo. This study aims to assess the performance of Determine™ TB LAM Antigen, a rapid diagnostic test (RDT) for tuberculosis. It was an evaluation study, conducted at the National Reference Laboratory for Mycobacteria located at the Sylvanus Olympio University Teaching Hospital in Lomé, Togo from 01 July to 15 November 2017. We performed the assessment onto 100 urine specimens collected from 100 subjects (HIV-infected or not). The test allows qualitative detection of the Lipo Arabinno Mannan (LAM) antigen of Mycobacteria in the urine. Bacilloscopy was chosen as gold standard. Overall, the test Determine™ TB LAM presented a sensitivity of 31.25% and a specificity of 95%. In contrast, the sensitivity and specificity of the test were respectively 82.35% and 66.67% in the group of HIV-infected subjects. In HIV non-infected subjects, the sensitivity was 17.46% and the specificity was 100%. Determine™ TB LAM Antigen test can help detect TB in HIV-infected people unable to expectorate in our settings.
Highlights
Tuberculosis is a major health problem worldwide, especially in the current context of HIV infection pandemic [1] [2]
This study aims to assess the performance of DetermineTM TB Lipo Arabinno Mannan (LAM) Antigen, a rapid diagnostic test (RDT) for tuberculosis
This study aims to assess the performance of ALERE DETERMINETM TB LAM Ag a rapid diagnostic test (RDT) for tuberculosis namely by determining its sensitivity, its specificity, its positive predictive value (PPV) and its negative predictive value (NPV)
Summary
Tuberculosis is a major health problem worldwide, especially in the current context of HIV infection pandemic [1] [2]. Tuberculosis control programs currently face some barriers related to the limitations of current diagnostic tools [4]. These include difficulties in obtaining and conditioning samples to be analysed, lack of infrastructures and materials as well as qualified human resources to carry out the test, and the delay of laboratory’s response [4]. The ability of Sputum smear microscopy to identify patients with TB may rely on the patient’s ability to produce “quality sputum”. Studies have shown that HIV infected patients are not able to produce “quality sputum” or produce paucibacillary sputum [6] resulting in possibly false negative microscopy results [7]. This study aims to assess the performance of ALERE DETERMINETM TB LAM Ag a rapid diagnostic test (RDT) for tuberculosis namely by determining its sensitivity, its specificity, its positive predictive value (PPV) and its negative predictive value (NPV)
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