The HbA1c Test Cassette (whole blood /serum /plasma) is based on Fluorescence immunoassay for the quantitative detection of HbA1c in whole blood.The measure of HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. This test can be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
The human erythrocyte is freely permeable to glucose. Within each erythrocyte a slow, continuous, non-enzymatic process between hemoglobin A and various sugars takes place. The product formed is known as glycated hemoglobin, or glycohemoglobin.
The chronic elevated blood sugar level of persons with diabetes mellitus will over time cause damage to the small vessels of the body. This damage develops slowly over years and is known to cause late complications. Good metabolic control, i.e. lowering the HbA1c concentration, has proven to delay the onset and slow the progression of diabeteslate complications. It is concluded that measurements of HbA1c can be used to diagnose diabetes mellitus. When in agreement with national regulations, FluroLitTM HbA1c Test can be used as an aid in the diagnosis of
diabetes and as an aid in identifying patients who may be at risk for developing diabete.
Refer to Novatrend TM Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be conducted in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test” or “Quick test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3. Whole blood: Transfer 10μL whole blood into the buffer tube with pipette; mix the specimen and the buffer throughly.
4. Add diluted specimen with a Pipette: Pipette 7μL diluted specimen into the sample well of the test cassette. Start the timer at the same time.
5. There are two test modes for Novatrend TM Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Novatrend TM Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 10 minutes after sample application and click "Test", the Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after sample application, click "New test" at the same time, the Analyzer will automatically counting down 10 minutes. After the countdown, the Analyzer will give the result at once.
INTERPRETATION OF RESULTS
Results read by FluroLitTM Fluorescence Immunoassay Analyzer.
The result of tests for HbA1c is calculated by FluroLitTM Fluorescence Immunoassay Analyzer and display the result on the screen. For additional information, please refer to the user manual of Novatrend TM Fluorescence Immunoassay Analyze.
Linearity range of FluroLitTM HbA1c Test is 4~ 14.5%.
||HbA1c Test Cassette