Diagnostics Evaluation Series No. 2
Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis
Summary
Accurate and prompt tuberculosis (TB) diagnosis is critical to disease control. Simple user-friendly and affordable detection tools could save lives and reduce overall costs borne by patients and health systems. Rapid, accessible serologic tests for tuberculosis are on the market, largely in developing countries, but little reliable information about their content and performance is available. Therefore, TB case detection remains dependent upon sputum smear microscopy, radiography and clinical symptomatology. In recent years, remarkable efforts have been made globally to improve access to, and the quality of, tuberculosis diagnostic services and to identify promising new diagnostic tools. Global case notification rates have increased and more than 15 diagnostic candidates are in the pipeline. However, still less than 20% of TB patients receive a microbiologically confirmed diagnosis. To this end, in cooperation with rapid TB test manufacturers, WHO/TDR sponsored an evaluation of commercially available rapid TB tests to assess their performance, reproducibility and operational characteristics and to identify promising candidates.