Performance of FDA-approved serologic testing for latex allergy in an at-risk population

Details

• Personal Author:
  Accetta DJ ; Elms N ; Hoffmann RG ; Kelly KJ ; Klancnik M ; Kurup VP ; Wang, Mei Lin
• Description:
  RATIONALE: Due to the lack of a FDA-approved skin testing reagent, diagnosis of latex allergy must rely on patient history and serologic assays. There has not been a recent large-scale study of skin and serologic testing in a low prevalence population to determine the PPV and NPV of serologic testing for latex allergy. METHODS: Health care workers underwent duplicate skin testing with Clone 600 extract and serologic testing for latex specific IgE measured by Pharmacia ImmunoCap. Sensitivity, specificity, PPV and NPV of the serologic assay were determined using skin prick testing as the gold standard for sensitization to latex. RESULTS: There were 792 paired skin and serologic tests. 40 skin tests were positive (5%). The sensitivity of the Pharmacia ImmunoCap assay was 35% and the specificity was 98%. The PPV was 48.3% while the NPV was 96.6%. There were 15 false positive serologic tests (1.9% of individuals tested) and 26 false negative tests (3.3%). CONCLUSIONS: Using an at risk population, with a 5% prevalence of latex allergy, we demonstrate that the performance of the FDA-cleared ImmunoCap serologic test for latex allergy has much lower sensitivity than previously reported. There were high rates of false positive and false negative results in relation to the prevalence of allergy in the population tested. This confirms suspicions that this serologic test should only be used for patients with a history of latex allergy and not used for screening the population with a low prevalence of latex sensitization. [Description provided by NIOSH]
• Subjects:
  Biological Assay Diagnosis Health Personnel Hypersensitivity Occupational Health Quality Control Safety Skin Skin Diseases
• Keywords:
  Allergens Allergic-dermatitis Allergic-reactions Allergies Bioassays Diagnostic-techniques Diagnostic-tests Failure-analysis Health-care-personnel Proteins Quality-control Reagents Sensitivity-testing Sensitization Serological-techniques Serology Skin-exposure Skin-irritants Skin-sensitivity Skin-tests Statistical-analysis Surveillance

  More +
• ISSN:
  0091-6749
• Document Type:
  Text
• Genre:
  Abstract or Summary
• Place as Subject:
  OSHA Region 3 ; OSHA Region 5 ; West Virginia ; Wisconsin
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  DRDS - Division of Respiratory Disease Studies
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  127
• Issue:
  2
• NIOSHTIC Number:
  nn:20038865
• Citation:
  J Allergy Clin Immunol 2011 Feb; 127(2)(Suppl 1):AB69
• Federal Fiscal Year:
  2011
• NORA Priority Area:
  Healthcare and Social Assistance
• Peer Reviewed:
  False
• Source Full Name:
  Journal of Allergy and Clinical Immunology
• Supplement:
  Supplement 1
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:85290b3bc3bcdd8738eaf03d1e8f04649ca8c542898924a21feb89fe09fb04d2342b676617e0a864ae0e476e3f28aa8c3d6e8d74c62a65c60cd2562435e6eb9b
• Download URL:
  https://stacks.cdc.gov/view/cdc/192412/cdc_192412_DS1.pdf
• File Type:
  [PDF - 38.36 KB ]