WHO-endorsed TB testing

WHO-endorsed tools (2006-2008)

Molecular line Strip test simultaneously detects TB bacteria and genetic mutations that indicate GenoType® MTBDR and Moderate (3 days) to High High probe assay isoniazid and/or rifampicin resistance.

MTBDR plus; INNO-LiPA Rif.

next day delivery from Genprice

Other test catridges avanilailable are
  • Capilia TB-Neo
  • Capilia mac
  • Capilia Flu Neo
  • Capilia Adeno Neo
  • Capilia RSV Neo
  • Capilia hMPV
  • Capilia Mycoplasma
  • Capilia mac

Tools in late-stage development/evaluation

Colorimetric redox indicators

Interferon gamma release assay LED fluorescence microscopy
Technique detects isoniazid and rifampicin resistance in culture samples after incubation with redox dyes.

Blood test detects specific cellular immune responses indicating TB infection.

Robust fluorescence microscopy (FM) systems based on light-emitting diodes (LEDs) that could allow the advantages of FM at levels of the health
Non-commercial method (Resazurin)

QuantiFERON®-TB Gold In Tube; T-SPOT.TB® Fraen
Extensive

system where conventional FM would be impractical. LW Scientific Zeiss
Moderate Medium Low Moderate Medium Low

Microscopic Observation Drug Susceptibility (MODS)

Manual liquid culture technique uses basic laboratory equipment (incl. an inverted light microscope) and microscopy skills to detect TB bacteria.

  • Non-commercial method
  • Extensive to Medium
  • Medium
  • Tools in early phase of development
  • 2Key Description

Basic laboratory4; no specialized biosafety equipment. Biosafety level 2. Specialized biosafety equipment required, such as biosafety cabinet. Biosafety level 3. Biosafety cabinet and other primary safety equipment required. Controlled ventilation system that maintains a directional airflow into the laboratory required.


1Estimates assume that technicians are already trained in existing TB diagnostic techniques (such as smear microscopy and culturing) and the necessary laboratory safety precautions. 3Product prices may vary depending on geographical location and terms of supply. Ranges are indicative only: Low (minimum-2000 US$); Medium (2001-7000 US$); high (7001+ US$). 4Detailed information available in the WHO Laboratory Biosafety Manual: http://www.who.int/csr/delibepidemics/WHO_CDS_CSR_LYO_2004_11/en/.
New solid culture Solid culture technique measures nitrate reduction to indicate isoniazid and methods rifampicin resistance. Solid culture technique simultaneously detects TB bacteria and indicate isoniazid and rifampicin resistance.
Non-commercial method (Nitrate reductase assay) Non-commercial method (Thin layer agar culture)

Breathalyser screening test Community or point-of-care First-generation loop-mediated isothermal amplification technology platform (LAMP) Peripheral laboratory Lipoarabinomannan (LAM) detection in urine Peripheral laboratory Phage-based tests Reference laboratory
Sodium hypochlorite (bleach) microscopy Sputum filtration TB Patch Test Vital fluorescent staining of sputum smears
Peripheral laboratory Peripheral laboratory Health post Peripheral laboratory Level of health system Tool Level of health system Too

Strip speciation Strip speciation test detects a TB-specific antigen from positive liquid or solid cultures to confirm the presence of TB bacteria in culture samples.

What is the best system for Tuberculosis testing?


=> Capilia TB Rapid Diagnostic Test
Minimal (1 day) training and Low Medium cost


Liquid culture Commercial broth-based culture systems detect TB bacteria (manual and automated systems are available); can be configured for DST.
BacT/ALERT 3D; MGIT Extensive (3 weeks) High High
Automated detection Device allows automated sample processing, DNA amplification and detection and MDR screening of M. tuberculosis and screening for rifampicin resistance.


Cepheid GeneXpert device and Xpert MTB cartridge