Table 1.
Studies evaluating accuracy of commercially available serodiagnostic tests for TB in childrena
| Antigen (assay) | Isotype | Age (yr) | Subject group (no. of subjects) | Sensitivity | Specificity | Comments | Reference |
|---|---|---|---|---|---|---|---|
| A60 (Anda-TB) | IgG, IgM | 0–11 | TB (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 groups | 22 |
| A60 (Anda-TB) | IgG, IgM | 2–12 | TB (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 mycobacteria | No information on M. tuberculosis culture results | 67 |
| A60 (Anda-TB) | IgG, IgM, IgA | 1–12 | TB (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 A60 | 29 |
| A60, 38 kDa (Anda-TB and Pathozyme-TB Complex) | A60, IgG and IgM; 38 kDa, IgG | 1–12 | TB (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 groups | 66 |
| PPD, HSP60, 38 kDa, 16 kDa (in-house ELISA, Pathozyme-Myco G, TB Complex Plus) | IgG, IgA, IgE | 0–15 | TB (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 addressed | 3 |
| A60, 38 kDa, 16 kDa, LAM (5 commercial tests)b | IgG, IgA, IgM | 0–18 | TB (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 yrs | Low specificity for all 5 assays tested; no clear value given | Mixtures of antigens tested in commercial kits; all subjects previously BCG vaccinated | 24 |
| 16 kDa, 38 kDa (Pathozyme-TB Complex Plus) | IgG | 0–15 | TB (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 distribution | 52 |
| TBLG (TBGL-Ab ELISA kit) | IgG, IgA | ≤12 | TB (23) (all culture+), healthy (24) | Low IgG and IgA responses in cases and controls, with no significant differences | No values given | Low sample numbers; no information on age distribution | 54 |
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.
Study evaluated Immunozyme Mycobacterium (IgG against A60; Assay Designs, Ann Arbor, MI).