Identifying ELISPOT and skin test cut-offs for diagnosis of Mycobacterium tuberculosis infection in The Gambia.

Int J Tuberc Lung Dis

Medical Research Council Labs, Bacterial Diseases Programme, Banjul, The Gambia.

Published: February 2006

AI Article Synopsis

  • The study was conducted in an urban area of The Gambia to determine optimal cut-off values for ELISPOT and PPD skin tests for tuberculosis detection.
  • The results indicated that the ideal cut-off for the ELISPOT tests (for both CFP-10 and ESAT-6 antigens) ranged between 4-8 spots for maximum sensitivity and specificity, with a combined sensitivity of 76.5%.
  • For the PPD skin test, a sensitivity and specificity equivalence was established at an induration cut-off of 9-13 mm.

Article Abstract

Setting: An urban area, The Gambia.

Objective: To identify ELISPOT and PPD skin test cut-offs, targeting sensitivity and specificity equivalence.

Design: Tuberculosis cases >5 years of age and their household contacts underwent ELISPOT, HIV and PPD skin tests. Cases and contacts sleeping in a different house were used to estimate sensitivity and specificity, providing two planes for estimating cut-offs. Specificity was adjusted for infection from previous exposure using a multivariate discrimination algorithm.

Results: The point on the line of intersection of the planes that maximised sensitivity and specificity equivalence occurred at 4 spots (95% confidence interval [CI] 3.5-5, multiplier=0 ) for CFP-10 and 5.5 spots (4.5-8, multiplier=0 for ESAT-6), yielding a sensitivity and specificity of 76% for both antigens. Combining ESAT-6 and CFP-10 using an 'or' statement yielded a maximum equivalence sensitivity and specificity of 76.5% at 6 spots for ESAT-6 and 11.5 spots for CFP-10. For the PPD skin test sensitivity and specificity, an equivalence of 78% occurred at 11 mm induration (9-13 mm).

Conclusion: An ELISPOT cut-off for ESAT-6 or CFP-10 could be set at 4-8 spot forming units (20-40 spots per million), with little benefit from combining the results. A cut-off of 9-13 mm for the PPD skin test is reasonable when comparing with the ELISPOT.

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