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Trinity Biotech's TRIstat HbA1c test:

This article was originally published in Clinica

Executive Summary

Irish diagnostics firm Trinity Biotech has gained US 510k approval of its TRIstat point-of-care HbA1c blood test. The TRIstat platform detects a patient's level of HbA1c, also known as glycated haemoglobin, a measure of their blood sugar control over the previous two to three months. The American Diabetes Association recommends that diabetic patients be tested for HbA1c at least four times a year. The test uses an affinity two-phase optical system, and can give results within minutes, the Dublin-based company claimed. Launch of the TRIstat product is slated for the first quarter of 2008. Trinity has not yet filed for CE-marking in Europe.

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