Diabetic Point of Care Testing Approved
The TRIstat HbA1c system, developed and manufactured by Trinity Biotech plc, was cleared by the FDA for marketing. The rapid, point of care test is used to monitor patients with diabetes. The approval was published by Reuters.
The newly approved test measures patient’s levels of glycolated hemoglobin. This value is an indicator of a patient’s diabetic control during the two or three months prior to measurement.
The TRIstat system incorporates Trinity’s Affinty Two-Phase Optical system along with a fully automated and simplistic design. This solution design provides HgbA1c results quickly and accurately while requiring minimal from effort from staff members completing the testing. The company argues that this system requires less work than other point-of-care systems that are currently available for monitoring HgbA1c.
This test can provide clinicians with information at the time of the patient encounter describing how well a patient is managing their sugar. Test results are available within ten minutes of running the patient specimen on the machine. Immediate test results allow clinicians to make necessary modifications, as needed, at the time of the patient’s office visit rather than requiring a second visit after test results become available.
Trinity already has two products available on the market for patients with diabetes that are used at the point of care, the PDQ and Ultra2.
Bio-Tech launched a similar product earlier this year, the in2it analyzer. As described on Hospital Buyer, that system also measures glycolated hemoglobin.
December 21, 2007 Related topics: Laboratory, Product Approval & Certification, Laboratory Equipment, Diagnostic