Product Name
Glycosylated Hemoglobin(HbA1c)Test Kit (Immunofluorescence Chromatography)
Purpose
To detect the content of HbA1c in human whole blood in vitro quantitatively.For Professional Use only.
Principles of Detection
The HbA1c Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing HbA1c antibody conjugated with fluorescent microspheres and a control antibody (goat anti-chicken IgY antibody) conjugated with fluorescence microspheres, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another HbA1c antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody).
HbA1c concentration in specimen is positively correlated with the fluorescent density of the microspheres, after the measure and calculation of the quantitative fluorescence immunoassay analyzer, then the analyzer would calculate the concentration of HbA1c according to the preset calibration curve in the machine and display the result, detection unit is %units. C line should appear in any cases, which indicates the reaction system is effective.
Storage conditions and shelf life
Store in a sealed aluminum foil bag at 2~30°C. After unpacking the aluminum foil bag under temperature 20~30 ºC , humidity 35~65%, please use it immediately.
Shelf life 18 months.
Applicable instrument
Avid fluorescent immunoanalyzer model: AI-IF 600
Specimen collection and preparation
- Human whole blood samples can be used for this test.
- Specimen collection:Collect blood specimen into a collection tube containing EDTA , evenly mixed before use. Do not use hemolyzed blood for testing.
Whole blood specimens should be stored at 2-8°C for no more than 4 hours if not test immediately. - Do not test patients' samples with severe hemolysis, lipemia and jaundice, all specimens should be treated as infectant.
- Restore the specimen to 20-30°C before the detection, cryopreserved specimen should be completely thawed, rewarmed and evenly mixed before use.
Performance Characteristics
- Linear range
In the range of 4%-14%, the r value should be ≥ 0.990. - Accuracy
Detected with the enterprise internal control accuracy reference (C1, C2), the test results should be within the following ranges.
(1) Detection with the enterprise internal control accuracy reference C1, the instrument measurement range is 6.4% ±15% at 15 minutes.
(2) Detection with the enterprise internal control accuracy reference C2, the instrument measurement range is 8.4% ±15% at 15 minutes.. - Intra-batch precision
Using the enterprise internal control precision reference (C9, C10) each parallel test 10 times, at 15 minutes instrumentation, the concentration value coefficient of variation CV≤15%.
4.Inter-batch precision
For three batches of reagent kits, 10 times of parallel testing with each enterprise internal control precision reference (C9, C10), and the instrument measurement at 15 minutes, the concentration coefficient of variation CV≤15%.
5.Detection limit
Detection with the enterprise internal control of the detection limit reference L1, instrumentation at 15 minutes, the results should be ≤4%.
6.Specificity
Detection with the enterprise internal control specificity reference (C3, C4, C5), the instrument measurement value at 15 minutes should be less than 6%.
