Table 2 Accuracy of the RISK6 signature benchmarked against the WHO target product profile for prediction of incident TB within 12 months of sample collection.

From: RISK6, a 6-gene transcriptomic signature of TB disease risk, diagnosis and treatment response

Cohort

RISK6 threshold at sensitivity set to ≥75%#

Specificity at sensitivity set to ≥75%#

RISK6 threshold at specificity set to ≥75%$

Sensitivity at specificity set to ≥75%$

Case samples

Control samples

AUC

AUC 95%CI

ACS (discovery)*

0.53

82.8%

0.46

82.8%

46

284

87.6%

82.8–92.4%

GC6–74*

0.35

50.0%

0.48

56.0%

50

372

70.6%

61.6–79.5%

  1. *Samples collected within 1 year of TB diagnosis. For GC6-74 participants from all three countries were combined.
  2. #Specificity and the RISK6 threshold are reported at a sensitivity of 75%, which is the minimum criterion specified in the TPP for an incipient TB test4. At a sensitivity of 75%, the minimum specificity as set out in this TPP should be ≥75%.
  3. $Sensitivity and the RISK6 threshold are reported at a specificity of 75%, which is the minimum criterion specified in the TPP for an incipient TB test4. At a specificity of 75%, the minimum sensitivity as set out in this TPP should be ≥75%.
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