Commercial serodiagnostic tests for diagnosis of tuberculosis

Overview

An antibody detection-based diagnostic test in a user-friendly format could potentially replace microscopy and extend tuberculosis diagnosis to lower levels of health services. Dozens of commercial serological tests for tuberculosis are being marketed in many parts of the world, despite previous systematic reviews having reported variable sensitivity and specificity of these tests.

Since the publication of these reviews, the evidence base has grown, methods for meta-analyses of diagnostic tests have evolved, and the WHO Stop TB Department (STB) has implemented a systematic approach to evidence synthesis for TB diagnostic policy development involving systematic reviews and meta-analyses, assessment of the evidence base by Expert Group review, and implementation of the GRADE process for evidence synthesis.