Test specification	Minimum required value
Medical decision	Treatment initiation
Sensitivity: adults (for pulmonary tuberculosis only; regardless of HIV status)	Pulmonary tuberculosis 95% for smear positive, culture positive 60% to 80% for smear negative, culture positive (detection of extrapulmonary tuberculosis being a preferred but not minimal requirement)
Sensitivity: children (including extrapulmonary tuberculosis; regardless of HIV status)	80% compared to culture of any specimen and 60% of probable tuberculosis (noting problem of lack of a gold standard)
Specificity: adults	95% compared to culture
Specificity: children	90% for culture‐negative probable tuberculosis (noting problem of lack of a gold standard) 95% compared to culture
Time to results	3 hours maximum (patient must receive results the same day) (desirable would be < 15 minutes)
Throughput	20 tests/day minimum, by one laboratory technician
Specimen type	Adults: urine, oral, breath, venous blood, sputum (desired: non sputum‐based sample type and use of finger prick instead of venous blood) Children: urine, oral, capillary blood (finger or heel prick)
Sample preparation	3 steps maximum Safe: biosafety level 1 Ability to use approximate volumes (that is, no need for precise pipetting) Preparation that is not highly time sensitive
Number of samples	1 sample per test
Readout	Easy‐to‐read, unambiguous, simple "yes", "no", or "invalid" answer Readable for at least one hour
Waste disposal	Simple burning or sharps disposal; no glass component Environmentally acceptable disposal
Controls	Positive control included in test kit Quality control simpler and easier than with sputum smear microscopy
Reagents	All reagents in self‐contained kit Kit contains sample collection device and water (if needed)
Storage/stability required	Shelf life of 24 months, including reagents Stable at 30°C, and at higher temperatures for shorter time periods Stable in high humidity environments
Instrumentation	If instrument needed, no maintenance required Instrument works in tropical conditions Acceptable replacement cost Fits in backpack Shock resistant
Power requirement	Can work on battery
Training	1 day maximum training time Can be performed by any health worker < USD 10 per test after scale‐up
Cost