Patient specific Performance testing standards

Taking the history of the patient and noting the clinical symptoms and localization of the lesions are critical. Allergen identification for a patient with a possible contact allergy to cosmetics is performed by means of patch testing with the standard series, specific cosmetic-test series, the product itself, and all of its ingredients. We can only find the allergens we look for. For skin tests with cosmetic products... 

All patients and control subjects were first routinely tested as follows SPT was performed with a standard panel of aeroallergens (including 5 molds) and blood samples were taken for total and specific IgE determination. RAST for IgE antibodies to A. altemata (Pharmacia, Uppsala, Sweden) was performed by using the allergen-specific CAP system with results converted into RAST classes from 0 to 4 according to the manufacturer s instructions. No antihistamine medication was used by any subject. Six of the 7 patients (but no control subjects) were RAST positive with a RAST class greater than 2. One patient was negative, but this person still showed a positive skin reaction to mf A. altemata enolase (see below). 

Initial Test of Matrix Effects Assay matrices are typically the most troublesome component in LBA. There should be careful consideration of this variable during method validation. Two types of tests are used to address the two major concerns surrounding matrix effects. These are performed in consideration of (1) whether there is a matrix difference between the standards and anticipated study samples that impacts the relative accuracy of an assay and (2) whether there are inter-individual or disease-specific differences in matrix in the target patient population. Two types of tests are used to evaluate such matrix effects spike recovery, where known amounts of analyte are mixed ( spiked ) into characterized matrix, and parallelism in patient samples. However, limited availability of patient samples may prevent the latter testing during the method feasibility phase. 

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