Table 1

Studies evaluating accuracy of commercially available serodiagnostic tests for TB in childrena

Antigen (assay)IsotypeAge (yr)Subject group (no. of subjects)SensitivitySpecificityCommentsReference
A60 (Anda-TB)IgG, IgM0–11TB (31) (14 culture+), healthy/TST+ (16), other diseases (198)IgG, 71% for culture+ TB and 65% for culture− TB; IgM, 19%IgG, 100%; IgM, 100%Small subgroups of TB cases when categorized by more-narrow age groups22
A60 (Anda-TB)IgG, IgM2–12TB (29) (no culture info), healthy/TST− (28), other diseases/TST− (53), healthy/BCG vaccinated (9), healthy/recent TST+ (35), old TB (23), adenitis due to other mycobacteria (11)IgG, 14%; IgM, 24%IgG and IgM, 94–100%; 74% in old TB; 91% in adenitis due to other mycobacteriaNo information on M. tuberculosis culture results67
A60 (Anda-TB)IgG, IgM, IgA1–12TB (208) (culture or clinically confirmed), probable TB (244), healthy (93), healthy TB contacts (15), other diseases (53)IgG, 32–48% depending on cutoff value; IgA, 36–38%; IgM, 55–57%; IgM and/or IgA, 82%IgG, 87–97% depending on cutoff value; IgM and/or IgA, 92%No categorization and comparison of results according to more-narrow age ranges; much higher IgM responses than in other studies with A6029
A60, 38 kDa (Anda-TB and Pathozyme-TB Complex)A60, IgG and IgM; 38 kDa, IgG1–12TB (42) (35 pulmonary, 7 lymphadenitis), healthy (22)IgG (A60), 29%; IgM (A60), 71%; IgG (38 kDa), 45%IgG (A60), 86%; IgM (A60), 50%; IgG (38 kDa), 73%No comment on how TB cases were diagnosed and no culture results given; no analysis according to more-narrow age groups66
PPD, HSP60, 38 kDa, 16 kDa (in-house ELISA, Pathozyme-Myco G, TB Complex Plus)IgG, IgA, IgE0–15TB (34) (poorly defined), healthy (46) (32 TST+, 14 TST−)IgG (PPD), 38%; IgA (PPD), 27%; IgE (PPD), 32%; IgG (HSP60), 38%; IgG (38 kDa and LAM), 20%; IgG (38 kDa and 16 kDa), 20%IgG (PPD), 96%; IgA (PPD), 93%; IgE (PPD), 77%; IgG (HSP60), 96%; IgG (38 kDa and LAM), 100%; IgG (38 kDa and 16 kDa), 100%Unclear how cutoff values were defined; rationale for testing IgE not addressed3
A60, 38 kDa, 16 kDa, LAM (5 commercial tests)bIgG, IgA, IgM0–18TB (81) (25 culture+, 31 pulmonary, 41 lymphadenitis, 40 other extrapulmonary); TST+ (30); healthy and other diseases (82)IgG (38 kDa), 0% for <10 yrs and 42% for >10 yrs; IgG (38 kDa and 16 kDa), 14% for <10 yrs and 36% for >10 yrs; IgG (38 kDa and LAM), 13% for <10 yrs and 27% for >10 yrs; IgA (38 kDa and LAM): 3% for <10 yrs and 15% for >10 yrs; IgM (38 kDa and LAM), 24% for <10 yrs and 50% for >10 yrs; IgG (A60), 0% for <10 yrs and 25% for >10 yrsLow specificity for all 5 assays tested; no clear value givenMixtures of antigens tested in commercial kits; all subjects previously BCG vaccinated24
16 kDa, 38 kDa (Pathozyme-TB Complex Plus)IgG0–15TB (32) (poorly defined; 24 pulmonary, 8 extrapulmonary), healthy (20), other diseases (20)25% (60% in culture+ TB, 18% in culture− TB])90%TB cases poorly defined; no information on age distribution52
TBLG (TBGL-Ab ELISA kit)IgG, IgA≤12TB (23) (all culture+), healthy (24)Low IgG and IgA responses in cases and controls, with no significant differencesNo values givenLow sample numbers; no information on age distribution54
  • a A60, antigen 60, complex consisting of various proteins and the glycolipid lipoarabinomannan; 38 kDa, 38-kDa culture filtrate protein, also known as antigen 5; PPD, purified protein derivative; HSP60, 60-kDa heat shock protein; 16 kDa, 16-kDa heat shock protein; LAM, the glycolipid lipoarabinomannan; TBLG, glycolipid trehalose-6-6-dimycolate; Anda-TB Kit, IgG, IgA, and/or IgM against antigen 60; Pathozyme-TB Complex, IgG against the 38-kDa protein; Pathozyme-TB Complex Plus, IgG against the 38-kDa and 16-kDa proteins (Omega Diagnostics, Alloa, Scotland); Pathozyme MycoG, MycoA, and MycoM, IgG, IgA, and IgM against the 38-kDa protein and LAM (Omega Diagnostics, Scotland); TBGL-Ab ELISA kit, IgG and IgA against TBLG (Kyowa Medex, Tokyo, Japan); TST, tuberculin skin test; TST+, positive TST; TST−, negative TST.

  • b Study evaluated Immunozyme Mycobacterium (IgG against A60; Assay Designs, Ann Arbor, MI).