Table 1 Studies reporting on the diagnostic accuracy of the determine TB-LAM assay
Study | Location | Patient population | No. of | Median CD4 | Number of | Reference | Urine testing | Overall | Sensitivity by | Overall | Results by |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Â | Â | Â | patients | count (IQR) | TB cases | standard | (retrospective | sensitivity | CD4 count | specificity | grade 1 |
| Â | Â | Â | screened | Â | (PTB/EPTB) | Â | or prospective) | n/N (%) | n/N (%) | n/N (%) | or grade 2 |
| Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | 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) |