Table 2 Minimum test specifications identified during the March 2009 experts' meeting, "Defining Specifications for a TB Point-of-Care Test"
From: New diagnostics for tuberculosis: fulfilling patient needs first
Criteria | Minimum specifications required |
|---|---|
Medical decision | Treatment initiation |
Sensitivity, adults (regardless of HIV status) | Pulmonary TB: Smear positive, culture positive: 95% Smear negative, culture positive: 60-80% (no agreement on a minimum) (detection of extrapulmonary TB preferred, but not required) |
Sensitivity, children (regardless of HIV status) | 80% compared to culture of any specimen and 60% of probable TB (noting the lack of a gold standard) |
Sensitivity, extrapulmonary TB (regardless of HIV status) | 80% compared to culture of any specimen and 60% of probable TB (noting the lack of a gold standard) |
Specificity | Adults: 95% compared with culture Children: 95% compared with culture, 90% for culture negative probable TB (noting the lack of a gold standard) |
Time to results | Maximum 3 hours (patient must obtain same-day results, desirable would be <15 minutes) |