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.
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.


CONCLUSIONS
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.
D000888:Antibodies, Anti-Idiotypic / Q000097:blood; D000918:Antibody Specificity; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology*; D020315:Latex Hypersensitivity / Q000097:blood* / Q000175:diagnosis*; D008722:Methods; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration