Performance Characteristics
Detection Limit: 3.00%;
Linear Range: 3.00%-15.00%;
Linear correlation coefficient R ≥ 0.990;
Precision: within batch C.V. is ≤ 10%; between batches C.V. is ≤ 15%;
Accuracy: Test cassettes from same batch were tested with HbA1c control of 5%, 10% and 15%, mean and Bias% were calculated, Bias% was within 10%..
1. Store the detector buffer at 2～30℃. The buffer is stable up to 18 months.
2. Store Aehealth HbA1c Rapid Quantitative Test cassette at 2～30℃, shelf life is up to 18 months.
3. Test cassette should be used within 1 hour after opening the pack.
Glycated hemoglobin (HbA1c) is a glycated form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. It is formed by the attachment of glucose residue in blood to hemoglobin molecule. The level of glucose is proportional to the amount of glycated hemoglobin. As the average amount of plasma glucose increases, the fraction of glycated hemoglobin increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement.