Diagnostic Performance of Food and Drug Administration-Cleared Serologic Assays for Natural Rubber Latex-Specific IgE Antibody. The Multi-Center Latex Skin Testing Study Task Force

Details

• Personal Author:
  Biagini, Raymond E. ; Hamilton, Robert G. ; Krieg EF
• Description:
  BACKGROUND: In the absence of Food and Drug Administration-approved natural rubber latex skin testing reagents, latex-specific IgE antibody immunoassays are used in the diagnosis of latex allergy. Comparative diagnostic performance of these tests has not been definitively determined. OBJECTIVE: We sought to study the predictive value of available Food and Drug Administration (510K)-cleared latex-specific IgE antibody immunoassays in the diagnosis of latex allergy. METHODS: Subjects (n = 312) were classified as having a positive (n = 117) or a negative (n = 195) latex allergy history (Hx) or having a positive (n = 131) or a negative (n = 181) puncture skin test (PST) response (Greer reagent). The 14 subjects with a negative Hx and a positive PST response had negative responses to glove provocation testing and thus were considered sensitized but asymptomatic. Sera from 22 subjects were split to evaluate intra-assay variation. All 334 coded sera were analyzed for latex-specific IgE antibodies in the Diagnostic Products Corporation microplate AlaSTAT, Hycor HY-TEC EIA System, and Pharmacia-UpJohn CAP System. Variance and diagnostic performance parameters of each test were computed with 95% confidence intervals in relation to the subjects' Hx and PST status. RESULTS: Intra-assay concordance of split sera results was 96.0% for all 3 assays, with coefficients of variation of less than 25% and between-assay coefficients of variation of less than 21%. The diagnostic performance of the CAP and AlaSTAT assays were equivalent in comparison with PST results: sensitivity, CAP 76.3% and ALASTAT 73. 3% and specificity, CAP 96.7% and AlaSTAT 97.2% (P = NS). The HY-TEC assay was more sensitive (91.6%) and less specific (73.3%) than the CAP and AlaSTAT assays (P <.001). From 9% to 25% of the sera were discordant, being positive in at least 1, but not all 3, assays. CONCLUSION: The CAP and AlaSTAT assays produce 24% and 27% of false-negative results, respectively, whereas the HY-TEC produces 27% of false-positive results when compared with the PST. [Description provided by NIOSH]
• Subjects:
  Antibodies Chemistry Chemistry, Analytic Hypersensitivity Laboratories Occupational Health Safety
• Keywords:
  Allergens Allergic-disorders Allergic-reactions Allergies Analytical-chemistry Analytical-methods Antibody-response Chemical-analysis Laboratory-testing Sensitivity-testing Sensitization Statistical-analysis

  More +
• ISSN:
  0091-6749
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  Maryland ; Ohio ; OSHA Region 3 ; OSHA Region 5
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  DBBS - Division of Biomedical and Behavioral Sciences
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  103
• Issue:
  5
• NIOSHTIC Number:
  nn:20028068
• Citation:
  J Allergy Clin Immunol 1999 May; 103(5)(Pt 1):925-930
• Federal Fiscal Year:
  1999
• Peer Reviewed:
  True
• Part Number:
  1
• Source Full Name:
  Journal of Allergy and Clinical Immunology
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:a4ea86cebd9f97a3995193987b6f6db368bc3838a28ee8a1d8e8731cde9bc71d37a9e17af522a559119771d7a9e545fa9c29cf42636b735513238bfcd7bff16f
• Download URL:
  https://stacks.cdc.gov/view/cdc/189759/cdc_189759_DS1.pdf
• File Type:
  [PDF - 65.99 KB ]