Point-of-care detection of lipoarabinomannan (LAM) in urine for diagnosis of HIV-associated tuberculosis: a state of the art review

Lawn, Stephen D

doi:10.1186/1471-2334-12-103

Table 1 Studies evaluating commercially available assays detecting urinary lipoarabinomannan (LAM) for diagnosis of tuberculosis (TB) in patients with culture-confirmed disease

From: Point-of-care detection of lipoarabinomannan (LAM) in urine for diagnosis of HIV-associated tuberculosis: a state of the art review

Study	LAM assay	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 assays for culture+ TB % (95%CI)		Overall specificity % (95%CI)	LAM results and non-tuberculous mycobacteria
									HIV+ subjects	HIV- subjects		% subjects with NTM who tested LAM+	% false- positive LAM with NTM cultured
Boehme et al. 2005 [30]	MTB ELISA, first prototype (Chemogen Inc)	Tanzania	Out-patient TB suspects	334	85	34	LJ culture	62 (54-70)	81 (71-88)	74 (57-86)	99 (94-100)	NS	NS
Lawn et al. 2009 [31]	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)	All: 33 (22-46)	N/A	100 (98-100)	None	None
									CD4>100: 13 (4-33)
									CD4 50-100: 41 (22-64)
									CD4<50: 67 (44-84)
Mutetwa et al. 2009 [32]	MTB ELISA, second prototype (Chemogen Inc)	Zimbabwe	Out-patient TB suspects	397	140	Not stated	LJ culture	75 (67-81)	52 (43-62)	21 (9-37)	89 (81-94)	NS	NS
Reither et al. 2009 [23]	MTB ELISA second prototype (Chemogen Inc)	Tanzania	Out-patient TB suspects	291	50	19	LJ and automated liquid culture	70 (58-79)	62 (48-74)	21 (8-44)	88 (79-94)	4/45 (8.9%)	4/14 (29%)
Daley et al. 2009 [33]	MTB ELISA, second prototype (Chemogen Inc)	India	Out-patient TB suspects	200	5	40	LJ and liquid culture	79* (66-89)	20 (1-70)	18 (8-32)	88 (81-92)	NS	NS
Shah et al. 2009 [34]	Clearview TB ELISA (Inverness Medical Innovations)	South Africa	In-patient HIV+ TB suspects	499	167	14	Automated liquid culture	42 (36-50)	All: 67 (59-74)	14 (3-41)	96 (91-99)	NS	NS
									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)
Dheda et al. 2010 [24]	Clearview TB ELISA (Inverness Medical Innovations)	South Africa	Out-patient TB suspects	500	44	80	Automated liquid culture	65 (57-72)	All: 21 (11-35)	6 (3-14)	99 (97-100)	NS	NS
									CD4<200: 37 (19-59)
Gounder et al 2011 [35]	Clearview TB ELISA (Inverness Medical Innovations)	South Africa	Active screening of HIV+ out-patients pre-ART or on ART	422	30	0	Automated liquid culture	27 (12-48)	All: 32 (16-52)	N/A	98 (96-99)	4/7 (57%)	4/8 (50%)
									CD4200-350: 10 (1-72)
									CD4<200: 35 (16-57)
									CD4<50: 56 (21-86)
Lawn et al. 2011 [12]	Clearview TB ELISA (Alere Inc.)	South Africa	Active screening of HIV+ out-patients pre-ART	516	85	0	Automated liquid culture	28 (19-39)	All: 27 (18-38)	N/A	98 (96-99)	2/8 (25%)	2/8 (25%)
									CD4>200: 8 (1-26
									CD4<200: 36 (24-49)
									CD4<150: 44 (29-59)
									CD4<100: 48 (29-68)
									CD4<50 61 (36-83)
Lawn et al 2012 [12]	Determine TB-LAM Ag point-of-care test	South Africa	Active screening of HIV+ out-patients pre-ART	516	85	0	Automated liquid culture	28 (19-39)	All: 28 (19-39)	N/A	99 (97-100)	2/8 (25%)	2/6 (33%)
									CD4>200: 4 (0-20)
									CD4<200: 39 (27-53)
									CD4<150: 46 (31-61)
									CD4<100: 52(33-71)
									CD4<50: 67 (41-87)
Peter et ak. 2012 [13]	Determine TB-LAM Ag point-of-care test	South Africa	In-patient HIV+ TB suspects	281 TB suspects + 88 non-TB controls	116	0	Automated liquid culture	56 (45-66)	Multiple different analyses using different gold standards and different assay cut-offs: see text for summary	N/A	See text	NS	NS

*of all TB diagnoses, not just culture-confirmed. 95%CI = 95% confidence intervals. Where 95%CI were not calculated in the original manuscripts, these have been calculated using the Wald method.
LJ = Lowenstein Jensen slopes. ELISA = enzyme-linked immunosorbent assay. ART = antiretroviral therapy. NS: not stated.

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