Expected Turnaround Time
8 - 15 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Serum, frozen
Volume
2.5 mL
Minimum Volume
1.0 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
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
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 |
© 2021 Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.
CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, 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