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Table 1 Studies reporting on the diagnostic accuracy of the determine TB-LAM assay

From: Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies

Study Location Patient population No. of Median CD4 Number of Reference Urine testing Overall Sensitivity by Overall Results by
    patients count (IQR) TB cases standard (retrospective sensitivity CD4 count specificity grade 1
    screened   (PTB/EPTB)   or prospective) n/N (%) n/N (%) n/N (%) or grade 2
            cutoff
Lawn et al. (2012) [7] Cape Town, South Africa Active screening of HIV + outpatients pre-ART 516 170 (100–233) PTB = 85 Sputum culture (liquid) Retrospective 24/85 (28.2) <50: 12/18 (66.7) 425/431 (98.6) Grade 1
<100: 15/29 (51.7)
<200: 23/59 (39.0)
≥200: 1/25 (4.0)
Peter et al. (2012) [15] Cape Town, South Africa Inpatient HIV + TB suspects 281 TB suspects +88 non-TB controls 90 (47–197) PTB + EPTB = 116 Sputum and non-sputum culture (liquid) Retrospective Grade 1 cutoff: 77/116 (66) Grade 1 cutoff: Grade 1 cutoff: 79/88 (89.8) Grade 1 and 2 reported
≤200: 58/81 (72) >200: 14/26 (54)
Grade 2 cutoff: 58/116 (50) Grade 2 cutoff: Grade 2 cutoff: 87/88 (98.9)
≤200: 47/81 (58) >200: 7/26 (27)
Dorman et al. (2012) [16] Cape Town, South Africa and Kampala, Uganda Inpatient and outpatient HIV + TB suspects 997 152 (41-337) Total cases = 16 Sputum culture (solid and liquid), + mycobacterial blood culture Prospective 136/367 (37.1) ≤100: 116/196 (59.2) 559/573 (97.6) Grade 2
PTB = 243
PTB + mycobact-eremia = 108
>100: 20/169 (11.8)
Mycobacteremia alone = 16
Van Rie et al. (2013) [17] Johannesburg, South Africa Mostly inpatient HIV + disseminated TB and EPTB suspects who could not produce sputum sample or were sputum smear and sputum Xpert negative (17% of patients NOT HIV+) 219 116 (34–221) EPTB + disseminated = 51 Culture (sputum, blood, lymph node FNA, CSF pleural fluid, ascitic fluid, urine) Not stated Any positive culture- 35/51 (68.8) In HIV-positives: Any positive culture: (91.8) Grade 2
<100: 82.6%
100–199: 63.3%
≥200: 40.0%
In HIV negatives: 0%
Drain et al. (2013) [18] Durban, South Africa Newly diagnosed HIV + out-patients 342 180 (73–311) 60 PTB (positive microbiology) Sputum smear or culture or Positive microbiology + clinical diagnoses Prospective PTB (micro+) only: 17/60 (28.3) PTB (micro+) only: No micro + PTB diagnosis: 254/282 (90.1) Unkown
<100: 12/32 (37.5)
100-199: 3/12 (25.0)
200-349: 1/3 (33.3)
≥350: 1/5 (20.0)
99 including PTB + EPTB + clinical diagnoses All diagnoses: 24/99 (24.2) All diagnoses No TB diagnosis: 222/243 (91.2%)
<100: 14/50 (28.0)
100-199: 4/20 (20.0)
200-349: 2/6 (33.3)
≥ 350: 2/11 (18.2)
Shah et al. (2013) [19] Uganda Inpatient and outpatient HIV + TB suspects 101 TB cases + 105 TB suspects with TB excluded 60 among those with TB 103 PTB + EPTB Sputum culture (solid and liquid), mycobacterial blood culture Retrospective 50/103 (48.5) <50:30/46 (65.2) 102/105 (97.1) Grade 2
51-100: 12/17 (70.6)
101-200: 4/19 (21.1)
>200: 4/21 (19.0)
  1. Specificity reported is for a control group of non-TB suspects to illustrate differences between grade 1 and 2 cut-offs.