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A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis
  1. Karen R Steingart1,
  2. Megan Henry2,
  3. Suman Laal3,
  4. Philip C Hopewell1,
  5. Andrew Ramsay4,
  6. Dick Menzies5,
  7. Jane Cunningham4,
  8. Karin Weldingh6,
  9. Madhukar Pai5
  1. 1Division 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. 2County of Sacramento Department of Health and Human Services, Sacramento, California, USA
  3. 3Veterans Affairs Medical Center and Departments of Pathology and Microbiology, New York University School of Medicine, New York, USA
  4. 4UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland
  5. 5Respiratory Epidemiology and Clinical Research Unit, Montréal Chest Institute and Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Canada
  6. 6Statens Serum Institut, Department of Infectious Disease Immunology, Copenhagen S, Denmark
  1. 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.

  • 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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Footnotes

  • This work was supported by the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR). AR and JC, both with TDR, contributed to the conception and design of the systematic review, and critical revision and decision to publish the manuscript. AR also participated in data interpretation.

  • Competing interests: KW is co-inventor on a number of patents relating to mycobacterial antigens which may be used for serological assays. All rights have been assigned to Statens Serum Institut.

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