Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

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.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® HbA1c
Format	Cassette	Reaction Time	10min
Linearity	3.8%～14%	Reference Interval	4.0%～6.0%
Sample	WB / FB	Certificate	CE / NMPA

ORDERING
Cat. No.	LMDBHB25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LADBHB25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T