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Table 1 TB diagnostic criteria

From: Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial

Symptom and x-ray result

Investigation results

Definition

Symptom positive and typical TB on x-ray

Sputum culture or Xpert positive

Definite TB

Sputum smear positive, culture negative/not available and Xpert negative/not available

Probable TB

Sputum smear negative, culture negative/not available and Xpert negative/not available

Possible TB

Symptom positive, possible TB on x-ray (including extra-pulmonary findings)

Sputum culture or Xpert positive

Definite TB

Sputum smear positive, culture negative/not available and Xpert negative/not available

Probable TB

Sputum smear negative, culture negative/not available and Xpert negative/not available

Possible TB

Histopathology positive, culture negative/not available and Xpert negative/not available

Probable TB

Other sample culture or Xpert positive

Definite TB

Symptom negative, typical TB on x-ray

Sputum culture or Xpert positive

Definite TB

Sputum smear positive, culture negative/not available and Xpert negative/not available

Probable TB

Sputum smear negative, culture and/or Xpert negative

Possible TB

Symptom positive, normal x-ray

Sputum culture positive

Definite TB

Sputum smear positive, culture negative/not available and Xpert negative/not available

Possible TB

Sputum smear negative, culture negative/not available and Xpert negative/ not available

Not TB

Histopathology positive, culture negative/not available and Xpert negative/ not available

Probable TB

Other sample culture or Xpert positive

Definite TB

Symptom negative, possible TB on x-ray (including extra-pulmonary findings)

Sputum culture or Xpert positive

Definite TB

Sputum smear positive, culture negative/not available and Xpert negative/not available

Possible TB

Sputum smear negative, culture negative/not available and Xpert negative/not available

Possible TB

Histopathology positive, culture negative/not available and Xpert negative/ not available

Probable TB

Other sample culture or Xpert positive

Definite TB

  1. 1A positive GeneXpert is regarded as having the same status as a positive culture result
  2. 2Symptoms include the clinical sign of adenopathy. ‘Histopathology’ includes microscopy/cell counts of fluid. These definitions regard the initial evaluation. Some patients with possible TB will be put on treatment. A clearcut response to treatment (e.g. improved symptoms and resolution of a pleural effusion) may be considered enough evidence to change a ‘possible’ to a ‘probable’ case
  3. 3For patients who die without recent TB evaluations, a verbal autopsy will be carried out wherever possible. An endpoint committee will review available data and categorise patients as definite, probable or possible TB; no evidence of TB at death; or unknown TB status at death