Suburban

TB Diagnosis Using GeneXpert and GeneXpert Ultra

Initial diagnostic tests with sample type as recommended by the WHO:(1)

Adults/ChildrenDiseaseRecommended SamplesRecommended Test(s)
Adults/Children

(with or without a history of TB)

Signs and symptoms of PTB/chest radiograph with lung abnormalities
  • Ideal sample: Sputum
  • Alternative samples (only in those who cannot produce sputum):
    • Nasopharyngeal aspirate
    • Gastric aspirate
GeneXpert

MTB/RIF

or

GeneXpert Ultra MTB/RIF

Signs and symptoms of EPTB
  • CSF
  • Lymph node aspirate
  • Lymph node biopsy
  • Pleural fluid
  • Peritoneal fluid
  • Pericardial fluid
  • Synovial fluid
  • Urine

PTB – Pulmonary TB; EPTB – Extrapulmonary TB

GeneXpert and GeneXpert Ultra are the recommended tests for Rapid TB Diagnosis.(1)

In case of a negative result on GeneXpert Ultra, broth-based culture can be done if there still exists a strong clinical suspicion of TB. (1)

Performance of GeneXpert & GeneXpert Ultra MTB/RIF (according to the WHO):(1)

Adults/ChildrenDiseaseSampleGeneXpert

MTB/RIF Sensitivity

GeneXpert Ultra

MTB/RIF Sensitivity

AdultsPTBSputum85%90%
PTB – Smear NegativeSputum67%77%
PTB – HIV +veSputum81%88%
EPTBCSF70%87%
EPTBLymph node aspirate89%78%
EPTBLymph node biopsy82%90% – 100%
EPTBPleural fluid50%71%
EPTBPeritoneal fluid59%Not Available*
EPTBPericardial fluid66%Not Available*
EPTBSynovial fluid97%96%
EPTBUrine85%100%
ChildrenPTBSputum65%73%
PTBGastric aspirate#73%Not Available*
PTBNasopharyngeal aspirate46%46%
PTB – Smear NegativeSputum59%Not Available*
PTB – HIV +veSputum72%Not Available*
PTB – HIV +veGastric aspirate#73%Not Available*
EPTBCSF54%Not Available*

* – Sensitivity not published by the WHO

# –  Gastric aspiration is not used for adults; it can be useful in children who cannot produce sputum.

GeneXpert MTB/RIF Ultra is the new, next generation GeneXpert test for TB:

  • Improved performance
  • 10-fold improvement in the lower limit of TB detection
  • Higher sensitivity, especially in smear negative cases
  • Increased accuracy of rifampicin resistance results

REFERENCES

  1. World Health Organization. WHO consolidated guidelines on tuberculosis: module 3: diagnosis: rapid diagnostics for tuberculosis detection [Internet]. 2021 update. Geneva: World Health Organization; 2021 [cited 2022 Mar 16]. Available from: https://apps.who.int/iris/handle/10665/342331
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