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Regenerating islet-derived 3-alpha serum

Test Code: 30146

Cpt Code:

83520 (x1)

Clinical Utility

For the quantitative measurement of REG3α. REG3α, an anti-inflammatory/anti-bacterial protein expressed in Paneth cells within the epithelium of the small intestine, has been shown to be elevated in medical conditions where immune dysregulation causes damage to the mucosal epithelial barrier.

Procedure

The assay for quantification of REG3α is a sandwich ELISA performed in a microtiter plate format. Conversion of a chromogenic substrate produces a color, the intensity of which is proportional to the concentration of REG3α in the sample material. A standard curve is used to calculate the concentration of REG3α in each of the test samples. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Specific to human REG3α.

Assay Range

The result is reported in ng/mL. The assay range is approximately 16.0 to 1000.0 ng/mL. The reference range for a healthy population is less than 75.0 ng/mL. However it should be noted that these ranges are obtained from a limited population of apparently healthy adults and are not diagnostic thresholds.

Causes For Rejection

Invalid specimen type, inadequate volume, gross hemolysis or gross lipemia, sample not frozen upon receipt.

Turnaround Time

Test performed M,W,F. TAT 3 - 5 days from receipt of specimen.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Specimen Information

serum

NY approved. Whole blood should be collected in serum tube, allowed to clot for 30 to 60 minutes and centrifuged to isolate the serum. 1 mL of serum should be removed to a sterile tube and frozen immediately (-70°C).

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-IBT's 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-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

Harris AC, Ferrara JLM, Braun TM, et al. Plasma biomarkers of lower gastrointestinal and liver acute GVHD. Blood. 2012 119:2960-2963.

Closa D, Motoo Y, lovanna JL. Pancreatitis-associated protein: From a lectin to an anti-inflammatory cytokine. World J Gastroenterol. 2007 13(2):170-174.

Gironella M, lovanna JL, Sans M, et al. Anti-inflammatory effects of pancreatitis associated protein in inflammatory bowel disease. Gut. 2005 54:1244-1253.

Choi B, Suh Y, Kim W-H, et al. Downregulation of regenerating islet-derived 3 alpha (REG3A) in primary human gastric adenocarcinomas. Exp Mol Med. 2007 39(6):796-804.

Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GvHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8.

 

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