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Clinical and Diagnostic Laboratory Immunology, November 2004, p. 1045-1053, Vol. 11, No. 6
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.6.1045-1053.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Establishment of Diagnostic Cutoff Points for Levels of Serum Antibodies to Pertussis Toxin, Filamentous Hemagglutinin, and Fimbriae in Adolescents and Adults in the United States

Andrew L. Baughman,^1* Kristine M. Bisgard,¹ Kathryn M. Edwards,² Dalya Guris,¹ Michael D. Decker,^3, Kathy Holland,^2, Bruce D. Meade,⁴ and Freyja Lynn⁴

National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia,¹ Department of Pediatrics, Division of Infectious Diseases,² Departments of Preventive Medicine and Medicine (Infectious Diseases), Vanderbilt University School of Medicine, Nashville, Tennessee,³ Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland⁴

Received 14 May 2004/ Returned for modification 16 July 2004/ Accepted 31 August 2004

Numerous reports have documented that serologic methods are much more sensitive than culture for the diagnosis of pertussis in adolescents and adults. However, a standardized serologic test for pertussis is not routinely available to most clinicians, and the serologic test levels or cutoff points correlated with diseases have not been determined. The goal of the present study was to examine the distribution of immunoglobulin G (IgG) levels against three Bordetella pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], and fimbria types 2 and 3 [FIM]) and to determine population-based antibody levels for the purpose of establishing such diagnostic cutoff points. Enzyme-linked immunosorbent assays (ELISAs) were performed with sera from >6,000 U.S. residents aged 6 to 49 years who participated in the Third National Health and Nutrition Examination Survey. Mixture models were developed to identify hypothesized exposure groups and establish diagnostic cutoffs. Quantifiable (>20 ELISA units/ml [EU]) anti-FHA and anti-FIM IgG antibodies were common (65 and 62% of individuals, respectively), but quantifiable anti-PT IgG antibodies were less frequent (16%). Given the distributions of antibody levels, an anti-PT IgG level of 94 EU was proposed as the diagnostic cutoff point. Application of this cutoff point to culture-confirmed illness in a prior study investigating cough illness yielded a high diagnostic sensitivity (80%) and specificity (93%). A standardized ELISA for anti-PT IgG with a single serum sample appears to be useful for the identification of recent B. pertussis infection in adolescents and adults with cough illness. The PT cutoff point will be further evaluated in prospective studies of confirmed B. pertussis infection.

Present address: Scientific & Medical Affairs, Aventis Pasteur, Swiftwater, Pa.

Present address: Clinical Trials Office, Vanderbilt-Ingram Cancer Center, Nashville, Tenn.

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