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A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis

¹ Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California, and Francis J Curry National Tuberculosis Center, San Francisco, California, USA
² County of Sacramento Department of Health and Human Services, Sacramento, California, USA
³ Veterans Affairs Medical Center and Departments of Pathology and Microbiology, New York University School of Medicine, New York, USA
⁴ UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland
⁵ Respiratory Epidemiology and Clinical Research Unit, Montréal Chest Institute and Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Canada
⁶ Statens Serum Institut, Department of Infectious Disease Immunology, Copenhagen S, Denmark

Correspondence to:
Correspondence to:
Dr Madhukar Pai
Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Canada, H3A 1A2;madhukar.pai{at}mcgill.ca

ABSTRACT
Conventional diagnostic tests for tuberculosis have several limitations and are often unhelpful in establishing the diagnosis of extrapulmonary tuberculosis. Although commercial serological antibody based tests are available, their usefulness in the diagnosis of extrapulmonary tuberculosis is unknown. A systematic review was conducted to assess the accuracy of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis. In a comprehensive search, 21 studies that reported data on sensitivity and specificity for extrapulmonary tuberculosis were identified. These studies evaluated seven different commercial tests, with Anda-TB IgG accounting for 48% of the studies. The results showed that (1) all commercial tests provided highly variable estimates of sensitivity (range 0.00–1.00) and specificity (range 0.59–1.00) for all extrapulmonary sites combined; (2) the Anda-TB IgG kit showed highly variable sensitivity (range 0.26–1.00) and specificity (range 0.59–1.00) for all extrapulmonary sites combined; (3) for all tests combined, sensitivity estimates for both lymph node tuberculosis (range 0.23–1.00) and pleural tuberculosis (range 0.26–0.59) were poor and inconsistent; and (4) there were no data to determine the accuracy of the tests in children or in patients with HIV infection, the two groups for which the test would be most useful. At present, commercial antibody detection tests for extrapulmonary tuberculosis have no role in clinical care or case detection.

Abbreviations: AUC, area under the curve; FPR, false positive rate; TPR, true positive rate; ROC, receiver operating characteristic; SROC, summary receiver operating characteristic

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