Diagnostic Immunobiochemistry: Interpretation and Reproducibility of FDA-Cleared Diagnostic Immunoassays for Latex Allergy

Details

• Personal Author:
  Biagini, Raymond E. ; Hamilton, Robert G. ; Krieg EF ; Mackenzie BA ; Robertson SK ; Striley CAF ; Viers DM
• Description:
  The absence of an FDA-licensed Hevea brasiliensis latex extract in the USA has restricted its use and serological tests have become critically important as diagnostic tools (JACI, 103:925-930, 1999). Three manufacturers (Pharmacia-UpJohn [CAP], Diagnostic Products Corporation [Ala] and HYCOR Biomedical [HY]) currently have FDA clearance for their in vitro latex kits. Paired-comparisons of results from the three assays indicates that they will disagree on the positive or negative status of some individual sera. Reproducibility as evaluated by repeated testing of low latex specific antibody concentration sera showed approximately 35% of results will vacillate between positive and negative results. Receiver operating characteristic (ROC) analyses of the three assays revealed significant differences in areas under the ROC curves. This may explain the wide disparity in reported seroprevalence rates for latex allergy and discordant data for individual sera between commercial assays, as well as the low sensitivity of these assays compared to PST. [Description provided by NIOSH]
• Subjects:
  Hypersensitivity Immune System Occupational Health Safety
• Keywords:
  Allergens Analytical-processes Immunochemistry Immunodiagnosis
• ISSN:
  0065-7727
• Document Type:
  Text
• Genre:
  Abstract or Summary
• Place as Subject:
  Ohio ; 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:
  219
• NIOSHTIC Number:
  nn:20035282
• Citation:
  Abstr Pap - Am Chem Soc 2000 Mar; 219(Pt 1):125-AGRO
• Federal Fiscal Year:
  2000
• Peer Reviewed:
  False
• Part Number:
  1
• Source Full Name:
  Abstracts of Papers - American Chemical Society
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:1d1cd554379782daa5f57c5b0ec4151600fd404f987d1187ecd277a8cd9ce7db43b859f3600cfec61ed1e1a14484ba7ef0d64a869552167ab2f3bd8a9054cc29
• Download URL:
  https://stacks.cdc.gov/view/cdc/187193/cdc_187193_DS1.pdf
• File Type:
  [PDF - 147.28 KB ]