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Journal of Clinical Microbiology, May 2008, p. 1672-1677, Vol. 46, No. 5
0095-1137/08/$08.00+0     doi:10.1128/JCM.02187-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Comparison of Serological and Real-Time PCR Assays To Diagnose Bordetella pertussis Infection in 2007

Sanofi Pasteur, 2 Avenue Pont Pasteur, 69367 Lyon Cedex 07, France,¹ Institut Pasteur, Unité Prévention et Thérapie Moléculaires des Maladies Humaines, URA-CNRS 3012, 25 rue du Dr Roux, 75015 Paris, France,² Department of Epidemiology, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina³

Received 13 November 2007/ Returned for modification 17 December 2007/ Accepted 18 March 2008

Bacterial culture for diagnosing pertussis infection has high specificity but poor sensitivity and is slow. Highly sensitive real-time PCR assays and single-serum pertussis serology have been developed to overcome these limitations, but there are few data available on the relative sensitivities and specificities of such assays for pertussis diagnosis. Using data on 195 participants (7 years old) from an epidemiological study, we assessed the sensitivity, specificity, and performance (Youden index) for pertussis diagnosis of the pertussis toxin enzyme-linked immunosorbent assay (using single and paired serology) and of real-time PCR assays (using the IS481 and ptxA-Pr targets). All available diagnostic information (clinical and laboratory) was pooled to serve as the gold standard. Single serology was the most efficient diagnostic test (Youden index, 0.57 to 0.58), with relatively high sensitivity (>64%) and high specificity (>90%), independent of the cutoff level. IS481 PCR performance was superior to that of ptxA-Pr PCR, and it was the second-most-efficient tool (Youden index, 0.30). Performing both ptxA-Pr and IS481 PCRs did not improve diagnostic performance. The greatest test efficiency (Youden index, 0.69 to 0.74) was achieved when single-serum serology was used in combination with IS481 or ptxA-Pr PCR or paired serology. Combining single serology with one PCR or paired serology increased the sensitivity with an associated limited decrease in specificity. The most specific tests for diagnosis of pertussis were single serology and ptxA-Pr PCR, and the most sensitive diagnostic tool was the combination of IS481 PCR with single serology.

Published ahead of print on 26 March 2008.

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