CLA® Allergen-Specific IgE Assay Package Insert - Hitachi ...

persons may result in anaphylactic reactions of varyingseverity.• When testing for inhalant allergies, false-positive resultsmay lead to improper medication of those persons. Falsenegativetest results may lead to lack of proper medicaltreatment.• If total IgE values are greater or equal to 500 IU/mL, lowlevelallergen-specific IgE response should be interpretedwith caution.• Reliable and reproducible results will be obtained whenthe assay procedure is carried out in complete accordancewith the product's instructions for use and adherence togood quality control procedures.• Bleach contamination has been found to interfere with thetest.Labware that has been decontaminated with bleachsolution should be rinsed thoroughly with distilled ordeionized water.• The use of alcohol-based solutions to disinfect theworkstation will result in cracking of the plastic andpremature failure of the workstation.13Expected ValuesThe CLA Classes were originally determined via scientific studiesto establish calibration curves using serum containing specificIgE antibodies to White Birch. The cutoff threshold betweenpositive and negative results was statistically established as twostandard deviations above the mean value of the normalpopulation. 6It is recommended that each laboratory establish its ownexpected reference range for the population of interest.14 Performance CharacteristicsA. Precision 12Within-Assay: Five replicates of four serum samples wererun in one batch. The average mean coefficient of variationof the responses of all the allergens tested, when calculatedas net LUs, was 11.7%.Between-Assay: Five replicates of four serum sampleswere run on four different days. The mean coefficient ofvariation of the responses of all allergens tested, whencalculated as net LUs, was 11.6%.B. Sensitivity 12The detection limit of the assay is 10 LUs.C. Specificity 12There is