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news.Trinity Biotech, a developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, has started the Clinical Laboratory Improvement Amendments trials for its TRI-stat point-of-care HbA1c product.
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According to Trinity, TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient’s average blood sugar control over the last two to three months. The availability of TRI-stat will reportedly improve overall efficiency of diabetes care by delivering HbA1c values during the patients’ visit to the doctor’s office.
Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products, the company said.
Ronan Caoimh, CEO of Trinity Biotech, said: “We are pleased to meet this important milestone event. TRI-stat has successfully passed internal and external research trials and we are confident of a successful outcome in the Clinical Laboratory Improvement Amendments (CLIA) trials.
“These trials are commencing this week and will take approximately four to six weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.”