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Table 3 Diagnostic performance of CFP-10pep assay for TB

From: Evaluation of a serum-based antigen test for tuberculosis in HIV-exposed infants: a diagnostic accuracy study

 

Confirmed TBα

Unconfirmed TBβ

Unlikely TBγ

MTB infectiona

No MTB infectionb

Total

MTB infection

No MTB infectionc

Total

All participants (N = 471)

 CFP-10pep +, no. (%)

6 (100.0)

34 (79.1)

17 (85.0)

51 (81.0)

6 (11.3)

16 (4.6)

22 (5.5)

 CFP-10pep −, no. (%)

9 (20.9)

3 (15.0)

12 (19.0)

47 (88.7)

333 (95.4)

380 (94.5)

 Sensitivity—% (95% CI)

100 (54.1–100.0)

79.1 (64.0–90.0)

85.0 (62.1–96.8)

81.0 (69.1–89.8)

 Specificity—% (95% CI)

88.7 (77.0–95.7)

95.4 (92.7–97.4)

94.5 (91.8–96.5)

HIV-infected participants (N = 266)

 CFP-10pep +, no. (%)

5 (100.0)

24 (80.0)

12 (92.3)

36 (83.7)

3 (9.4)

12 (6.4)

15 (7.7)

 CFP-10pep −, no. (%)

6 (20.0)

1 (7.7)

7 (16.3)

29 (90.6)

174 (93.6)

203 (92.3)

 Sensitivity—% (95% CI)

100 (47.8–100.0)

80.0 (61.4–92.3)

92.3 (64.0–99.8)

83.7 (69.3–93.2)

 Specificity—% (95% CI)

90.6 (75.0–98.0)

93.6 (89.0–96.6)

93.1 (88.9–96.1)

HIV-uninfected participants (N = 205)

 CFP-10pep +, no. (%)

1 (100.0)

10 (76.9)

5 (71.4)

15 (75.0)

3 (14.3)

4 (2.4)

7 (4.3)

 CFP-10pep −, no. (%)

3 (23.1)

2 (28.6)

5 (25.0)

18 (85.7)

159 (97.6)

177 (96.2)

 Sensitivity—% (95% CI)

100 (2.5–100.0)

76.9 (46.2–95.0)

71.4 (29.0–96.3)

75.0 (50.9–91.3)

 Specificity—% (95% CI)

85.7 (63.7–97.0)

97.6 (93.8–99.3)

96.2 (92.3–98.5)

  1. CI confidence interval
  2. αConfirmed TB: Mtb culture-positive
  3. βUnconfirmed TB: ≥ 2 types of non-bacteriological TB evidence within 12 weeks
  4. γUnlikely TB: no or insufficient evidence of TB or a confirmed alternative diagnosis (did not have active TB)
  5. aTST positive (induration of ≥ 5 mm for HIV-infected children and ≥ 10 mm for HIV-uninfected children)
  6. bTST negative (induration of < 5 mm for HIV-infected children and < 10 mm for HIV-uninfected children)
  7. cTST-negative or no TST result available for children not suspected of TB who did not reach a protocol-designated visit for TST performance (parent study weeks 96, 144, 196)
  8. CFP-10pep diagnostic sensitivity was calculated using the sample drawn closest (± 24 weeks; ± 1 study visit for the HIV-uninfected cohort following INH/placebo treatment) to the time of their retrospective diagnosis by 2015 NIH criteria