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Related Experiment Video

Updated: Jul 25, 2026

Isolation of Human Islets from Partially Pancreatectomized Patients

Isolation of Human Islets from Partially Pancreatectomized Patients

Published on: July 30, 2011

The World Health Organization International Collaborative Study for islet cell antibodies.

A R Mire-Sluis¹, R Gaines Das, A Lernmark

¹Division of Immunobiology, National Institute for Biological Standards and Control, Potters Bar, UK.

|November 18, 2000

Summary

A new international standard (97/550) significantly reduces variability in measuring islet cell autoantibodies, GAD65, and IA-2 antibodies. This standard is crucial for accurate Type 1 diabetes diagnostics and research.

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Electrochemiluminescence Assays for Human Islet Autoantibodies

Electrochemiluminescence Assays for Human Islet Autoantibodies

Published on: March 23, 2018

Area of Science:

Immunology
Endocrinology
Biotechnology

Background:

Islet cell autoantibodies are specific markers for Type 1 diabetes.
Standardization of antibody measurements is critical for research and diagnostic assay development.

Purpose of the Study:

To evaluate a candidate serum (97/550) as the international standard for islet cell antibodies.
To assess its suitability as a standard for glutamic acid decarboxylase 65 kDa isoform (GAD65) and islet antigen-2 (IA-2) antibodies.

Main Methods:

A candidate serum (97/550) was lyophilized and distributed to 19 participants in 8 countries.
Participants assessed its suitability as a standard for islet cell, GAD65, and IA-2 antibodies.
Control sera were used to validate assay systems.

Main Results:

The use of 97/550 significantly reduced inter-laboratory variability in measuring islet cell antibodies.
A pronounced reduction in inter-laboratory variability was also observed for GAD65 and IA-2 antibodies.

Conclusions:

Preparation 97/550 was established as the first international standard for islet cell antibodies (20 IU).
It also serves as an international reference reagent for GAD65 antibodies (100 units).
97/550 is a NIBSC reference reagent for IA-2 antibodies, aiding assay evaluation.