PhenX - respiratory - immunoglobulin E - total and specific protocol 090701

Resp immunoglobulin E proto

Definition

Blood collection and bioassay for ascertaining levels of Immunoglobulin E. Licensing and guideline requirements for manufacturers and laboratories performing these tests have been set forth by the Food and Drug Administration and the Clinical Laboratory Improvement Amendment of 1988. These measures have assisted in ensuring more consistent results but do not address either accuracy or precision parameters in a comprehensive fashion. In summary, one of the major challenges in the development of consistent allergy testing is the need to identify and accept a well-recognized test standard. An ideal immunoassay for specific IgE antibodies should meet certain analytic performance criteria. These criteria include a slope of unity over the useful measurement range for all allergens, low variation across replicate measurements, statistically determined limits of detection, a practical cut-off point, and defined saturation points. For an assay to be considered as a standard, it would require close approximation to these criteria. There is currently no established standard in this field.

Immune globulin; Immuno; Immunoglob; Immunoglobin; Imunoglbon; Imunoglobn; Pan; Panel; PANEL.PHENX; Panl; Pnl; Point in time; Random; Resp immunoglobulin E proto; Spec; Tot; Totl