Published online December 29, 2008
PEDIATRICS Vol. 123 No. 1 January 2009, pp. 38-43 (doi:10.1542/peds.2008-0611)
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ARTICLE

Comparison of T-SPOT.TB Assay and Tuberculin Skin Test for the Evaluation of Young Children at High Risk for Tuberculosis in a Community Setting

Mark P. Nicol, FCPath, PhDa,b,c, Mary-Ann Davies, MBChBa,d, Kathryn Wood, Nat Dipa, Mark Hatherill, MD, FCPaeda,b, Lesley Workman, RNa,b, Anthony Hawkridge, MBChB, FCPHMa,b, Brian Eley, MBChB, FCPaeda, Katalin A. Wilkinson, PhDc,e, Robert J. Wilkinson, FRCP, PhDc,e,f, Willem A. Hanekom, MBChB, FCPaeda,b,c, David Beatty, FCPaed, PhDa and Gregory Hussey, FCPaed, PhDa,b,c

a School of Child and Adolescent Health
d School of Public Health and Family Medicine
c Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa
b South African Tuberculosis Vaccine Initiative, Cape Town, South Africa
e National Institute for Medical Research, London, England
f Division of Medicine, Wright Fleming Institute, Imperial College, London, England

OBJECTIVE. We wished to compare the sensitivity of an enzyme-linked immunospot assay (T-SPOT.TB; Oxford Immunotec, Oxford, United Kingdom) and the tuberculin skin test for the detection of tuberculosis infection in very young children being evaluated for active tuberculosis in a rural community setting.

METHODS. Children with a history of exposure to tuberculosis and children presenting to a local clinic or hospital with symptoms suggesting tuberculosis were admitted to a dedicated case verification ward. T-SPOT.TB testing was performed, and children were evaluated with a clinical examination, a tuberculin skin test, chest radiographs, and cultures of induced sputum and gastric lavage specimens. The diagnosis was determined by using a clinical algorithm.

RESULTS. A total of 243 children (median age: 18 months) were recruited, of whom 214 (88%) had interpretable T-SPOT.TB results. Children ≥12 months of age were more likely than younger children to have positive T-SPOT.TB results, whereas tuberculin skin test results were unaffected by age. The sensitivity of the T-SPOT.TB was no better than that of the tuberculin skin test for culture-confirmed tuberculosis (50% and 80%, respectively) and was poorer for the combined group of culture-confirmed and clinically probable tuberculosis (40% and 52%, respectively). For the 50 children clinically categorized as not having tuberculosis, the specificity of both the T-SPOT.TB and the tuberculin skin test was 84%.

CONCLUSIONS. For young children presenting in a community setting after exposure to tuberculosis or with symptoms suggesting tuberculosis, T-SPOT.TB cannot be used to exclude active disease. The sensitivity of this assay may be impaired for very young children.

Key Words: tuberculosis • T-SPOT.TB • children • enzyme-linked immunospot assay • Mantoux test

Abbreviations: ELISpot—enzyme-linked immunospot assay • ESAT-6—early secreted antigenic target-6 • TST—tuberculin skin test • ELISA—enzyme-linked immunosorbent assay • OR—odds ratio • CI—confidence interval

Accepted Apr 10, 2008.


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