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

General Details:

Name:: PhenX - respiratory - immunoglobulin E - total and specific protocol 090701
Steward:: LOINC
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.
Registration Status:: Qualified

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Designation:: PhenX - respiratory - immunoglobulin E - total and specific protocol 090701
Tags:: Long Common Name

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.
Tags:: Source: Regenstrief LOINC

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Language Code:: en-US
Document:: Williams, P. B., Barnes, J. H., Szeinbach, S. L., & Sullivan, T. J. (2000). Analytic precision and accuracy of commercial immunoassays for specific IgE: establishing a standard. Journal of Allergy and Clinical Immunology, 105(6), 1221-1230.

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Language Code:: en-US
Document:: Dolen, WK. (2003). IgE antibody in the serum--detection and diagnostic significance. Allergy, 58(5), 717-723.

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Code System	Code	Code Text	Code Version
https://www.phenxtoolkit.org	PX090701010000	PX090701_IgE_Concentration		https://www.phenxtoolkit.org	90701	immunoglobulin_e_(total_and_specific)

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Fully-Specified Name

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Component	Property	Time	System	Scale	Method
PhenX - respiratory - immunoglobulin E - total and specific protocol 090701	-	Pt	^Patient	-	PhenX

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Basic Attributes

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Class	Type	First Released	Last Updated	Change Reason
PANEL.PHENX	Clinical	Version 2.36	Version 2.66	Updated the PhenX ID from "PhenX." to "PX" in Survey Question Source field to align with the variable identifier used in the PhenX Toolkit.; Added the PhenX protocol ID to the Component to clearly define the protocol version for which this panel is based upon.