1001 NW Technology Drive, Lee's Summit, MO 64086 // (800) 305-5198 // (816) 347-0143 Fax // info@viracor-eurofins.com 185022 - Alpha Amylase IgG4 - 3/28/2024 7:45:19 PM Page of Alpha Amylase IgG4 Test Code: 185022 Clinical and Procedure Clinical Utility The clinical utility of food-specific IgG4 tests has not been clearly established. Physicians sometimes use allergen-specific IgG4 to evaluate patients prior to or during immunotherapy. These tests can be used in special clinical situations. This test should only be ordered by physicians who recognize the limitations of the test. Procedure Enzyme immunoassay (FEIA). A standard curve is used to calculate the specific IgG concentrations. The calibrators are referenced to the International Reference Preparation for serum immunoglobulins . This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. Turnaround Time 2-3 business days from receipt of specimen Specimen Information Specimen Type Order Code CPT Code NY Approved Volume Assay Range Serum (1) 185022 86001 No 0.5 mL (min. 150 uL) See Limit of Quantitation Guide Special Instructions - Collect 1-2 mL whole blood in red top tube. - Centrifuge and transfer 0.5 mL serum into a transfer tube. - Ship at ambient or frozen temperature Monday through Friday. - Specimens are stable for 4 weeks refrigerated or ambient; freeze for longer storage.   mcg/mL of IgG4 Lower Limit of Quantitation 0.30 Upper Limit of Quantitation 30.0 Reference ranges vary by allergen. Disclaimer Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material. Error page

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