Overview

Several noncommercial culture and drug-susceptibility testing (DST) methods have been developed specifically for settings with limited access to sophisticated laboratory infrastructure and technical expertise. Several rapid, inexpensive methods have shown initial promise. The most advanced are microscopic observation of drug susceptibility (MODS), colorimetric redox indicator (CRI) methods, thin-layer agar methods, the nitrate reductase assay (NRA) and mycobacteriophage-based assays.

In 2009, the strength of the evidence for these noncommercial methods was assessed by WHO, following standards appropriate for evaluating both the accuracy of new TB diagnostics and their effect on patients and public health. The results showed that the current evidence is insufficient to recommend the use of thin-layer agar or phage-based assays. There was considered to be sufficient evidence for the use of CRI methods, MODS and NRA under clearly defined programme and operational conditions, in reference laboratories and under strict laboratory protocols, and as an interim solution while capacity for genotypic or automated liquid culture and DST is being developed.

Under these conditions, MODS and NRA are recommended for direct testing of sputum specimens. Together with CRI methods, MODS and NRA are also recommended for indirect DST of M. tuberculosis isolates grown in conventional culture. The time to detection of MDR-TB may not necessarily be faster with indirect testing, and none of these methods can detect extensively drug-resistant TB. Conventional culture and DST capacity are therefore still required in all settings.

Contents

• Abbreviations
• Executive summary
• 1. Background
• 2. Evidence for policy formulation
  • 2.1 Synthesis of evidence
  • 2.2 Management of declarations of interest
  • 2.3 Premises for adopting new diagnostic tools and methods
• 3. Summary of results
  • 3.1 Colorimetric redox indicator methods
  • 3.2 Microscopically observed drug susceptibility
  • 3.3 Nitrate reductase assay
• 4. Policy recommendations
• 5. Intended audience
• 6 References
• Annexes
  • Annex 1 Expert Group Members
  • Annex 2 WHO staff members
  • Annex 3 STAG-TB members

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