HbA1c testing
FDA Clears Sekisui Dx's HbA1c Assay
Seksui's test is used in clinical labs to measure the percent concentration of HbA1c or the HbA1c fraction mmol/mol in human venous whole-blood and hemolysate.
The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.
Abbott HbA1c Test FDA Cleared to Diagnose Diabetes
The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.
The study found that for some patients the standard practice of performing a second confirmatory blood test is not necessary, which could streamline care.