Table 1.
Studies Evaluating Commercially Available Assays Detecting Urinary Lipoarabinomannan (LAM) for the Diagnosis of Tuberculosis in Patients With Culture-Confirmed Disease
| Study | ELISA version | Country | Study population | Total subjects (n) | HIV+ subjects with culture+ TB (n) | HIV- subjects with culture+ TB (n) | Culture method | Sensitivity of sputum microscopy % (95%CI) | Sensitivity of LAM ELISA in Culture+ TB % (95%CI) |
Overall Specificity % (95%CI) | ||
| All subjects | HIV+ subjects | HIV- subjects | ||||||||||
| Boehme et al 2005 [93] | MTB ELISA, first prototype (Chemogen Inc) | Tanzania | Out-patient TB suspects | 334 | 85 | 34 | LJ culture | 62 (54–70) | 80 (72–87) | 81 (71–88) | 74 (57–86) | 99 (94–100) |
| Lawn et al 2009 [95] | MTB ELISA, second prototype (Chemogen Inc) | South Africa | Active screening of HIV+ out-patients pre-ART | 235 | 58 | 0 | Automated liquid culture | 14 (7–25) | 33 (22–46) | All: 33 (22–46) CD4>100: 13 (4–33) CD4 50–100: 41 (22–64) CD4<50: 67 (44–84) |
N/A | 100 (98–100) |
| Mutetwa et al 2009 [96] | MTB ELISA, second prototype (Chemogen Inc) | Zimbabwe | Out-patient TB suspects | 397 | 140 | Not stated | LJ culture | 75 (67–81) | 44 (36–52) | 52 (43–62) | 21 (9–37) | 89 (81–94) |
| Reither et al 2009 [97] | MTB ELISA second prototype (Chemogen Inc) | Tanzania | Out-patient TB suspects | 291 | 50 | 19 | LJ and automated liquid culture | 70 (58–79) | 51 (39–62) | 62 (48–74) | 21 (8–44) | 88 (79–94) |
| Daley et al 2009 [98] | MTB ELISA, second prototype (Chemogen Inc) | India | Out-patient TB suspects | 200 | 5 | 40 | LJ and liquid culture | 79a (66–89) | 18 (9–33) | 20 (1–70) | 18 (8–32) | 88 (81–92) |
| Shah et al 2009 [99] | Clearview TB ELISA (Inverness Medical Innovations) | South Africa | In-patient HIV+ TB suspects | 499 | 167 | 14 | Automated liquid culture | 42 (36–50) | 59 (52–66) | All: 67 (59–74) CD4>200: 55 (41–69) CD4150-200: 14 (4–58) CD4150-200: 56 (30–80) CD450-100: 71 (51–87) CD4<50: 85 (73–93) |
14 (3–41) | 96 (91–99) |
| Dheda et al 2010 [100] | Clearview TB ELISA (Inverness Medical Innovations) | South Africa | Out-patient TB suspects | 500 | 44 | 80 | Automated liquid culture | 65 (57–72) | 13 (8–19) | All: 21 (11–35) CD4<200: 37 (19–59) | 6 (3–14) | 99 (97–100) |
Where 95% confidence intervals (CI) were not calculated in the original manuscripts, these have been calculated using the Wald method.
Abbreviations: ART, antiretroviral therapy; CI, confidence intervals; ELISA, enzyme-linked immunosorbent assay; LJ, Lowenstein–Jensen slopes.
a
Of all TB diagnoses, not just culture-confirmed.