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Receiver operating characteristics analyses of food and drug administration-cleared serological assays for natural rubber latex-specific immunoglobulin E antibody.

Authors
Biagini-R; Krieg-E; Pinkerton-L; Hamilton-R
Source
Clin Diagn Lab Immunol 2001 Nov; 8(6):1145-1149
NIOSHTIC No.
20021673
Abstract
Receiver operating characteristics (ROC) analyses to evaluate and compare the diagnostic accuracy of Food and Drug Administration (510K)-cleared natural rubber latex (NRL)-specific immunoglobulin E (IgE) antibody immunoassays have not been performed using well-characterized skin-testing reagents. Sera were collected from 311 subjects (131 latex puncture skin test [PST] positive and 180 PST negative). All masked, coded sera were analyzed for latex-specific IgE antibodies in the Diagnostic Products Corporation microplate AlaSTAT, HYCOR HY-TEC RAST, and Pharmacia-Upjohn CAP System RAST FEIA (CAP). Diagnostic accuracy was evaluated using GraphRoc for Windows software to construct and analyze ROC curves in relation to the subjects' PST status and the results of the immunoassays. The ROC areas under the curve (AUCs) +/- standard error based on PST for the three diagnostic tests were 0.858 +/- 0.024, 0.869 +/- 0.024, and 0.924 +/- 0.017, respectively, for AlaSTAT, CAP, and HY-TEC. The HY-TEC system had a significantly greater AUC based on PST than those observed for AlaSTAT (P < 0.05) and CAP (P < 0.05) analyses. When the diagnostic tests were probed as to the cutoffs giving maximal diagnostic efficiency compared to PST, CAP and AlaSTAT yielded values of <0.35 kU of allergen IgE (kU(A))/liter and <0.35 kU/liter while the HY-TEC assay yielded 0.11 kU/liter. The diagnostic efficiencies based on PST in our cohort at these cutoffs were 87.1, 88.1, and 88.7%, respectively. The HY-TEC assay had a significantly greater AUC than CAP and AlaSTAT using PST as a diagnostic discriminator in our cohort. When the HY-TEC system was probed at its maximally efficient cutoff (0.11 kU/liter) versus HYCOR's recommended cutoff of 0.05 kU/liter, a loss of sensitivity of 8.4% was observed with a gain in specificity of 19.5%.
Keywords
Serology; Serological-techniques; Immunoglobulins; Skin-tests; Antibody-response; Humans
Contact
Division of Applied Research and Technology, National Institute for Occupational Safety and Health, MS-C26, 4676 Columbia Parkway, Cincinnati, OH 45226
CODEN
CDIMEN
Publication Date
20011101
Document Type
Journal Article
Email Address
reb4@cdc.gov
Fiscal Year
2002
NTIS Accession No.
NTIS Price
Issue of Publication
6
ISSN
1071-4138
NIOSH Division
DART
Source Name
Clinical and Diagnostic Laboratory Immunology
State
OH; MD
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