Evaluation of Commercial Assays for Single-Point Diagnosis of Pertussis in the US

Details

• Alternative Title:
  J Pediatric Infect Dis Soc
• Personal Author:
  Pawloski, Lucia ; Plikaytis, Brian ; Martin, Monte ; Martin, Stacey ; Prince, Harry ; Lape-Nixon, Mary ; Tondella, M. Lucia
• 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.
  
  
• Subjects:
  Adhesins, Bacterial Antibodies, Bacterial Antigens, Bacterial Bordetella Pertussis Humans Immunoenzyme Techniques Immunoglobulin A Immunoglobulin G Immunoglobulin M Pertussis Toxin Reagent Kits, Diagnostic Sensitivity And Specificity Serologic Tests Virulence Factors, Bordetella Whooping Cough

  More +
• Keywords:
  Diagnostics ELISA Serology
• Source:
  J Pediatric Infect Dis Soc. 6(3):e15-e21
• Pubmed ID:
  27451419
• Pubmed Central ID:
  PMC8574169
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Place as Subject:
  United States
• Volume:
  6
• Issue:
  3
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:f46a0f4ebb7c24b38ca143a012a28abf88133eacf67515f96f997c56602114aaf9b049984ccb0adbf1a389f2a18a986f9a78e59051f778d97b3b32d3a1b55ad0
• Download URL:
  https://stacks.cdc.gov/view/cdc/111472/cdc_111472_DS1.pdf
• File Type:
  [PDF - 936.30 KB ]