Isocyanate HDI IgE, Allergen

Last Modified: 3/27/2019 4:28:16 PM


  Medicare Medical Necessity Restrictions May Apply
Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements: 1.0 mL Serum from a SST Gold Top Tube
 
Collection Instructions:  
Minimum Volume: 0.3 mL Serum
Transport & Storage: Temperature/Stability:

7 days Ambient
14 days Refrigerated
30 days Frozen

Reference Range:

Specific                                                 Level of Allergen
IgE Class               kU/L                       Specific IGE Antibody
---------                    ------------                ---------------------

0                              <0.10                      Absent/Undetectable
0/1                          0.10 - 0.34             Very Low Level
1                              0.35 - 0.69             Low Level
2                              0.70 - 3.49             Moderate Level
3                              3.50 - 17.4             High Level
4                              17.5 - 49.9             Very High Level
5                              50 – 100                Very High Level
6                              >100                       Very High Level
 
The clinical relevance of allergen results of 0.10 - 0.34 kU/L are undetermined and intended for specialist use. Allergens denoted with a ** include results using one or more analyte specific reagents. In those cases, the test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Critical Ranges:  
Test Comments:  
Methodology: Immunocap
Clinical Significance:  
Documentation:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 4 to 7 days
Days Performed: Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Quest - Valencia
PHL Test Code: AG142
EPIC Test Code: IMO153
Send Out Test Code: 37917
Alternate Test Names: Allergen, Isocyanate HDI IgE; K77
Included Tests:  
CPT Coding: 86003

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