Quality Controls in Allergy Diagnosis Alistair Crockard Royal Hospitals Belfast Northern Ireland Quality Controls in Allergy Diagnosis • What do we want? • What can be controlled? • What can be achieved? What do we want? 1. A process that ensures that: the results generated are correct What do we want? 1. A process that ensures that: the results generated are correct QUALITY CONTROL What do we want? 2. A process that ensures: the quality of results is consistent and in line with those determined for recognised reference material (standards) What do we want? 2. A process that ensures: the quality of results is consistent and in line with those determined for recognised reference material (standards) QUALITY ASSESSMENT What do we want? 3. A process that ensures: the correcttest is carried out on the correct sample and the correctresult, with the correctinterpretation, is delivered to the correctperson at the correcttime. What do we want? 3. A process that ensures: the correcttest is carried out on the correct sample and the correctresult, with the correctinterpretation, is delivered to the correctperson at the correcttime. QUALITY ASSURANCE What do we want? 4. Guidelines: CLSI Approved Guidelines I/LA20-4 (1997) “Evaluation methods and analytical performance characteristics of immunology assays for human IgE antibodies of defined specificities” 2nd Edition due late 2008 www.clsi.org What can be controlled? Steps in the Analytical Process
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