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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. 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. 2
    County of Sacramento Department of Health and Human Services, Sacramento, California, USA
  3. 3
    Veterans Affairs Medical Center and Departments of Pathology and Microbiology, New York University School of Medicine, New York, USA
  4. 4
    UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland
  5. 5
    Respiratory Epidemiology and Clinical Research Unit, Montral Chest Institute and Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montral, Canada
  6. 6
    Statens Serum Institut, Department of Infectious Disease Immunology, Copenhagen S, Denmark
  1. Dr Madhukar Pai, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montral, 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 0.001.00 and specificity range 0.591.00 for all extrapulmonary sites combined; 2 the Anda-TB IgG kit showed highly variable sensitivity range 0.261.00 and specificity range 0.591.00 for all extrapulmonary sites combined; 3 for all tests combined, sensitivity estimates for both lymph node tuberculosis range 0.231.00 and pleural tuberculosis range 0.260.59 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.

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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.

  • This is a reprint of a paper that appeared in Thorax, October 2007, Volume 62, pages 9118. Reprinted with kind permission of the authors and publisher.

  • 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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