title: Receiver operating characteristics analyses of Food and Drug Administration-cleared serological assays for natural rubber latex-specific immunoglobulin E antibody.
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%.
authors.affiliation: Division of Applied Research and Technology, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Public Health Service, Department of Health and Human Services, Cincinnati, Ohio 45226, USA reb4@cdc.gov.
authors.forename: R E
authors.initials: RE
authors.lastname: Biagini
authors.forename: E F
authors.initials: EF
authors.lastname: Krieg
authors.forename: L E
authors.initials: LE
authors.lastname: Pinkerton
authors.forename: R G
authors.initials: RG
authors.lastname: Hamilton
mesh_terms: D000888:Antibodies, Anti-Idiotypic; D018795:Device Approval; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D007073:Immunoglobulin E / Q000032:analysis / Q000276:immunology*; D020315:Latex Hypersensitivity / Q000175:diagnosis* / Q000276:immunology*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012882:Skin Tests; D014481:United States
chemical_list: D000888:Antibodies, Anti-Idiotypic; C026408:anti-IgE antibodies; D007073:Immunoglobulin E