Diagnostic immunobiochemistry: interpretation and reproducibility of FDA-cleared diagnostic immunoassays for latex allergy.
Biagini RE; Krieg EF; Hamilton RG; Striley CAF; Mackenzie BA; Viers DM; Robertson SK
Abstr Pap - Am Chem Soc 219(Part 1):125-AGRO
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.
Immunochemistry; Immunodiagnosis; Allergens; Analytical-processes
Abstracts of Papers - American Chemical Society