PACKAGE
1 test/pouch,10tests/kit

INTENDED USE

glycosylated hemoglobin is an in vitro diagnostic test for quantitative detection of the concentration of glycosylated hemoglobin in human whole blood . Corollary used with RL-A2000 Portable Quantitative Immunoassay Analyzer .

TEST PRINCIPLE

HbA1C Rapid Test Device is a sandwich immunoassay. when test, samples of HbA1C antigen and HbA1C antibody on the conjugate first occur immune reaction, form immune complex .  Immune complex flow as the sample in the nitrocellulose membrane , And react with the in advance coating HbA1C antibodies ,then be fixed. The more HbA1C in the blood ,the more compound exit in the test line ,  optical density in the test line will be higher accordingly . Meantime , in the test process , internal controled Combination will also chromatography along with the sample in the nitrocellulose membrane, react with the coated antibody ,then fixed .After the reaction, RL-A2000 portable immune quantitative analyzer will analyzed the optical density in control line and test line ,calculating the test result, then get the relative optical density value. Final, Detector begin to calculate and display the results of HbA1C concentration based on the standard curve that up front set in the detector ,showed in %.

MATERIAL PROVIDED

Test kit : HbA1C  Rapid Test Device (Colloidal Gold)

100ul Disposable plastic pipette

5ul Disposable plastic pipette

Centrifuge tube

ID Chip (HbA1C)

Manual

STORAGE & VALID DATE

Store the test device at 2 to 30. Do Not Freeze.

Valid for 18 months

SPECIMEN REQUIRED

1, Whool blood can be used in the testing.

2, With the standard method of clinical laboratory extraction of , treatment process should be fast.

3, The sample should be detected as soon as possible, avoiding prolonged standing at room temperature. If specimen of whole blood cannot be detected immediately. Collected  specimen should be detected immediately .

4, Before the detection of samples must be restored to room temperature, mixed well , then can be used.

5, Blood specimen for transportation, should strictly abide by the state laws and regulations on the transport of blood products.