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Evaluation of Commercial Assays for Single-point Diagnosis of Pertussis in the US
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9 01 2017
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Source: J Pediatric Infect Dis Soc. 6(3):e15-e21
[PDF-936.30 KB]
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Alternative Title:J Pediatric Infect Dis Soc
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Description:Background:
Pertussis serodiagnosis is increasingly being used in the US despite the lack of an FDA approved, commercially-available assay. To better understand the utility of these assays in diagnosing pertussis, serology assays were evaluated for analytical parameters and clinical accuracy.
Methods:
Forty-three antigen-antibody combinations were evaluated for single-point diagnosis of pertussis. Serum panels included sera from laboratory-confirmed cases, an international reference standard, and healthy donors. Phase I panel (n=20) of sera was used to assess precision, linearity, and accuracy; phase II panel (n=226) followed with positive (PPA) and negative percent agreement (NPA) estimates. Analytical analyses included coefficients of variation (CV) and concordance correlation coefficients (rc).
Results:
Intra-analyst variability was found to be relatively low among samples per assay, with only 6% (78/1240) having CV > 20%, primarily with the highly concentrated IgG anti-pertussis toxin (PT) specimens and IgM assays. rc measurements to assess linearity ranged between 0.282–0.994, 0.332–0.999, and −0.056–0.482 for IgA, IgG, and IgM, respectively. Analytical accuracy for calibrated IgG anti-PT assays was 86–115%. PPA and NPA varied greatly for all assays; PPA/NPA ranges for IgA, IgG, and IgM assays, with culture and/or PCR-positivity as control, were 29–90/13–100, 26–96/27–100, and 0–73/42–100, respectively. In IgG assays, mixing filamentous hemagglutinin (FHA) antigen with PT increased PPA, but decreased NPA.
Conclusions:
Seroassays varied substantially under both analytical and clinical parameters; however, those that were calibrated to a reference standard were highly accurate. Our findings support incorporation of calibrated pertussis seroassays to the pertussis case definition for improved diagnosis and surveillance.
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Pubmed ID:27451419
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Pubmed Central ID:PMC8574169
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