Package size
10 tests/kit, 25 tests/kit, 50tests/kit, 100tests/kit
Intended use
HbA1c is a fluorescence Immunoassay (FIA) for the quantitative determination of HbA1c(Hemoglobin A1c) in human whole blood or peripheral blood. It is useful as an aid in management and monitoring of the longterm glycemic status in patients with diabetes mellitus.
For in vitro diagnostic use only
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 protein is formed post-translationally through the slow,
nonenzymatic reaction between glucose and amino groups on proteins.
HbA1c is a clinically useful index of mean glycemia during the preceding
120 days, the average life span of erythrocytes. Carefully controlled
studies have documented a close relationship between the
concentrations of HbA1c and mean glycemia. HbA1c is considered as a
more reliable parameter in monitoring glycemia over the glycemic
reading with the conventional glucometer.
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 |
FAQ
Q: What about the Applicable Analyzers?
A: LYOFIA® HbA1c Microfluidic Reagent POCT Test kit can be applicable to LYOFIA-I, LYOFIA8, and LYOFIA100,
Q: What is the time of reaction?
A: LYOFIA® HbA1c Microfluidic Reagent POCT Test only takes 10 minutes for reaction.
Q: Peripheral Blood sample is applicable?
A: Yes. Peripheral Blood sample is applicable to our LYOFIA® HbA1c Microfluidic Reagent POCT Test. .
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