Diabetes Autoimmune Profile

CPT: 86337(x1); 86341(x3)
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Test Details

Use

Diabetes autoantibodies assessment is helpful in identifying and managing patients at risk for development of type 1 diabetes. Published positivity rates for diabetes autoantibodies in new-onset type 1 diabetes patients listed below are based on the combined analysis of GAD-65, ICA 512, insulin antibodies, and ZnT8 antibodies. The combined analysis has a 98% autoimmunity detection rate, with 1.8% diabetic individuals remaining as autoantibody-negative. fewer than 3% of type 2 diabetics have positive antibodies.1

Positive rate in new-onset type 1 diabetes patients:

• GAD-65 antibodies = 68% positive

• ICA 512 antibodies = 72% positive

• Insulin antibodies = 55% positive

• ZnT8 antibodies = 63% positive

An increase in the number of positive antibodies is associated with a higher likelihood of type 1 diabetes.

Methodology

Enzyme-linked immunosorbent assay (ELISA), radioimmunoprecipitation

Specimen Requirements

Specimen

Serum, frozen

Volume

1.5 mL

Minimum Volume

0.5 mL (Note: This volume does not allow for repeat testing.)

Container

Red-top tube or gel-barrier tube

Collection

Transfer specimen to a plastic transport tube before freezing. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested.

Storage Instructions

Freeze. Stable at room temperature or refrigerated for one day. Stable frozen for seven days. Freeze/thaw cycles: stable x3.

Causes for Rejection

Gross hemolysis; lipemic specimen; EDTA plasma

Clinical Information

Footnotes

1. Wenzlau JM, Juhl K, Yu L, et al. The cation efflux transporter ZnT8 (Slc30A8) is a major autoantigen in human type 1 diabetes. Proc Natl Acad Sci U S A. 2007 Oct 23; 104(43):17040-17045. 17942684

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504050 Diabetes Autoimmune Profile 141600 Insulin Antibodies uU/mL 8072-1
504050 Diabetes Autoimmune Profile 500610 Anti GAD 65 Antibodies U/mL 56540-8
504050 Diabetes Autoimmune Profile 141533 IA-2 Autoantibodies U/mL 31209-0
504050 Diabetes Autoimmune Profile 504017 ZNT8 Antibodies U/mL 76651-9
504050 Diabetes Autoimmune Profile 504004 Type 1 Diabetes Interpretation 8251-1
504050 Diabetes Autoimmune Profile 503964 Diabetes Autoimmune Profile N/A

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf