Parkview Health Laboratory: Test Directory

Medicare Medical Necessity Restrictions May Apply

Medical Necessity Documentation:

Patient Preparation:

Specimen Requirements:

1.0 mL Serum from a Red Top Tube in a Plastic Vial

Collection Instructions:

Minimum Volume: 0.3 mL Serum

Transport & Storage: Temperature/Stability:

4 weeks Ambient
4 weeks Refrigerated
4 weeks Frozen

Rejection Criteria: Lipemic

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: Radioimmunoassay

Clinical Significance:

Documentation: The test method is a radioimmunoassay (RIA). Allergens are covalently coupled to the cellulose paper discs via the APT method. 125I-labelled anti-IgE is used to quantify the patient's specific IgE.To improve sensitivity, Viracor-IBT Laboratories provides an additional low range calibrator at 0.1 kU/L and 0/1 class. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. - See more at: http://www.viracor.com/Test-Catalog/Detail/Bean-Pinto-Phaseolus-vulgaris-IgE--56310S#sthash.98mhHtQs.dpuf

Custom Panel: No

Turn Around Time: 4 to 7 days

Days Performed: Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday

Sites Performed: Quest - Valencia to ViaCor IBT

PHL Test Code: MSOT

EPIC Test Code: IMO248

Send Out Test Code: 56310S

Alternate Test Names: Allergen, Pinto Bean IgE; Phaseolus vulgaris

Included Tests:

CPT Coding: 86003

Parkview Laboratory: Test Directory

Pinto Bean IgE, Allergen

PRODUCTION SCHEDULE