Diabetes Autoimmune Profile (Insulin Ab, GAD 65 Ab, IA-2 Ab, ZNT8 Ab, Interpretation)

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Turnaround Time: 8-15 Days
CPT Code:

86337, 86341(3)

Test Type: 2.5 mL Serum, frozen
Stability Time:

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

Reference Range:

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

Overview:

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.

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. PubMed 17942684

Collection Details:

Collection Instructions:

Red-top tube or gel barrier tube.

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.

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