This device is intended to be used for the in vitro quantitative determination of Glycated Haemoglobin (HbA1c) in human whole blood, or peripheral blood. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.
Summary
Glycated hemoglobin refers to the glycosylated hemoglobin in red blood cells. Its content is proportional to the blood glucose concentration. It can reflect the average blood glucose level of the subject in the past 8 to 12 weeks. It is not affected by the timing of the blood draw, fasting, insulin use, and other factors that can cause transient fluctuations in blood glucose levels. And its concentration is relatively stable in the blood, which is often regarded as an important detection indicator for early diagnosis of diabetes and the effect of blood glucose control. It is mainly used in clinical diagnosis of diabetes and monitoring of blood glucose levels, and helps to assess the risk of complications.
The current clinical methods for detecting HbA1c include chemiluminescence, immunochromatography and so on.
TEST INFORMATION
Reference Interval
4.0%~6.0%
Certificate
CE / NMPA
Linearity
3.8%~14%