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Table 1 Baseline demographics and clinical characteristics of study participants by HIV and TB status

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

  HIV-infecteda HIV-uninfected
Total (N = 284) TBb (N = 66) Unlikely TBc (N = 218) Total (N = 235) TBb (N = 51) Unlikely TBc (N = 184)
Age—days
 Median 95 96 95 93# 93 93#
 Range 91 to 120 91 to 120 91 to 120 91 to 120 91 to 119 91 to 120
WHO weight-for-age z score
 Median − 1.35 − 1.39 − 1.10 − 0.33# − 0.46# − 0.30#
 Range − 5.84 to 3.48 − 5.84 to 2.17 − 5.84 to 3.48 − 4.96 to 1.98 − 4.96 to 1.87 − 3.34 to 1.98
 Male sex—no. (%) 116 (40.8) 29 (42.4) 87 (39.9) 126 (53.6)# 27 (52.9)# 99 (53.8)#
Race or ethnic group—no. (%)
 Indigenous African 283 (99.6) 66 (100.0) 217 (99.5) 234 (99.6) 51 (100.0) 183 (99.5)
 Mixed ancestry or other 1 (0.4) 0 (0.0) 1 (0.5) 1 (0.4) 0 (0.0) 1 (0.5)
Breast-feeding—no. (%)
 Ever breast-fed 42 (14.8) 6 (9.1) 36 (16.5) 19 (8.1)# 2 (4.0) 17 (9.2)#
 Breast-fed at baseline 22 (7.7) 4 (6.1) 18 (8.3) 3 (1.3)# 0 (0.0) 3 (1.6)#
Parent study arm—no. (%)d
 Isoniazid 150 (52.8) 33 (50.0) 117 (53.7) 113 (48.1) 23 (45.1) 90 (48.9)
 Placebo 134 (47.2) 33 (50.0) 101 (46.3) 122 (51.9) 28 (54.9) 94 (51.1)
Maternal history of tuberculosis—no. (%) 13 (4.6) 5 (7.6) 8 (3.7) 15 (6.8) 3 (5.9) 12 (6.5)
 During index pregnancy 1 (0.4) 1 (1.5) 0 1(0.4) 0 1 (0.5)
 Before index pregnancy 12 (4.2) 4 (6.1) 8 (3.7) 14 (6.4) 3 (5.9) 11 (6.0)
CDC clinical HIV category—no. (%)e
 N (asymptomatic) 223 (79.6) 53 (81.5) 170 (79.1)
 A (mildly symptomatic) 43 (15.4) 9 (13.9) 34 (15.8)
 B (B moderately symptomatic) 14 (5.0) 3 (4.6) 11 (5.1)
CD4+ percentage—%
 Median 30 25 30ǂ
 Range 6 to 58 9 to 48 6 to 58
CD4+ percentage category—no. (%)f
 < 20% 52 (19.7) 14 (23.7) 38 (17.7)
 20–24% 33 (12.5) 14 (23.7) 29 (13.5)
 25–34% 104 (39.4) 21 (35.6) 83 (38.6)
 ≥ 35% 75 (28.4) 10 (16.9) 65 (30.2)
Plasma HIV-1 RNA at entry—copies/ml
 Median 527,000 750,000 386,000ǂ
 Range ≤ 400 to > 750,000 ≤ 400 to > 750,000 ≤ 400 to > 750,000
TB related parameters—n/N (%)g
 MTB culture 5/111 (4.5) 5/61 (8.2) 0/50 (0.0) 5/68 (7.4) i 5/42 (11.9) 0/26 (0.0)
 AFB smear 14/114 (12.3) 9/64 (14.1) 5/50 (10.0) 9/70 (12.9) 6/44 (13.6) 3/26 (11.5)
 TST 78/202 (38.6) 46/66 (69.7) 32/136 (23.5)ǂ 51/226 (22.6)# 30/51 (58.8) 21/175 (12.0)
 TB contact exposure 39/41 (95.1) 27/28 (96.4) 12/13 (92.3) 34/38 (89.5) 21/24 (87.5) 13/14 (92.9)
 Chest X-ray 75/134 (56.0) 58/66 (87.9) 17/68 (25.0)ǂ 61/98 (62.2) 49/51 (96.1) 12/47 (25.5)ǂ
 Signs/symptoms consistent with TB 13/284 (4.6) 10/66 (15.2) 3/218 (1.4)ǂ 11/235 (4.7) 6/51 (11.8) 5/184 (2.7)ǂ
 Positive response to anti-TB therapyh 38/77 (49.4) 37/60 (61.7) 1/17 (5.9)ǂ 33/61 (54.1) 32/46 (69.6) 1/15 (6.7)ǂ
  1. HIV status was determined following enrollment; TB status was retroactively applied to the study population using the 2015 NIH criteria
  2. Symbols denote p values < 0.05 for differences between the TB and unlikely TB groups (ǂ) and the HIV-infected and HIV-uninfected groups (#)
  3. aTwo participants were HIV-uninfected at entry but tested HIV-infected approximately 24 weeks after enrollment and therefore classified as HIV-infected
  4. bParticipants with confirmed TB (Mtb culture-positive) and unconfirmed TB (≥ 2 types of non-bacteriological evidence of TB) evaluated as a group since the size of the confirmed TB group (N = 8; see Fig. 1) prevent meaningful comparisons with other groups
  5. cUnlikely TB: children never suspected of TB or suspected of TB but with no, or insufficient, evidence for TB diagnosis, or with a confirmed alternative diagnosis
  6. dChildren enrolled in the P1041 parent study received INH prophylaxis for up to 96 weeks or until achieving a primary endpoint (first occurrence of TB disease or Mtb infection, or death from any cause) to evaluate whether primary INH prophylaxis improved TB disease-free survival among HIV-infected children or Mtb infection-free survival among HIV-uninfected children in a population immunized with the BCG vaccine
  7. eFour participants with missing data and HIV-uninfected participants at entry were not included from the percentages
  8. f20 participants with missing data and HIV-uninfected participants at entry were not included from the percentages
  9. gn/N (%) indicate the number of children with positive results per the total number of children with this information and the percent of children with a positive result
  10. hChildren classified as TB cases (definite, probable, and possible TB) according to the P1041 protocol or as having “non-algorithm TB” by clinical experts were started on anti-TB treatment. The majority of children identified as TB cases in the P1041 study were also categorized as TB cases by the 2015 NIH criteria (Table S10)
  11. iTwo TB patients with culture positive results were first diagnosed as unconfirmed TB