【Intended use】

Hemoglobin A1c (HbA1c) Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of Hemoglobin A1c (HbA1c) content in human blood. Hemoglobin A1c (HbA1c) is a combination of hemoglobin and blood sugar in human blood, and is positively related to blood sugar concentration. The combination is irreversible. HbA1c disappears with the death of red blood cells (the life span of red blood cell is around 120 days), and therefore, it can reflect the average blood sugar levels in the first 2-3 months of blood collection. The increase of  HbA1c can change the affinity of erythrocyte to oxygen, making tissues and cells anoxia, accelerating the formation of cardiovascular complications; can cause the thickening of glomerular basal membrane, inducing diabetic nephropathy (DN); can cause the increase of blood lipids and blood viscosity, and is an important factor in the occurrence of cardiovascular disease. It can also significantly reduce the compliance of red blood cells (that is, the ability to deform), making it difficult for red blood cells to penetrate the walls of blood vessels and bring oxygen into the tissue. Therefore, it is of great significance to monitor HbA1c for disease control in diabetic patients, the prediction of complications, and the screening of diabetic patients. The common detection methods in Clinic are Turbidity method, immunofluorescence method, enzymatic method and high performance liquid chromatography (HPLC) method.

【Test principle】

The assay is a double-antibody sandwich immunoassay for quantitative determination of HbA1c concentration based on immunofluorescence technology. The sample droplets to be measured were added to the sample well of the detection card. Through chromatography, the sample reacts with the fluorescent latex coated with hemoglobin monoclonal antibody I on the conjugated pad. The complex spread forward along the nitrocellulose membrane captured by the HbA1c monoclonal antibody and hemoglobin monoclonal antibody II, which was fixed on the test line. The more HbA1c in the sample, the more complexes accumulated on the test line. The intensity of the fluorescent antibody signal reflected the amount of HbA1c and hemoglobin captured. The concentration of HbA1c in the sample can be determined by the Immunofluorescence quantitative analysis instrument produced by Norman Biological.

【Package】

25 Tests /Box

【Sample Type】

Whole blood

【Materials provided】

Contents

25       Cartridges

1         Calibration Card

25        Sample diluents

25        Disposable tips

【Accessories required but not provided】

²  Immunofluorescence quantitative analyzer（NRM-FI-1000）

²  Reagent strip incubator

²  HbA1c Control

【Storage and stability】

Sealed: The kit must be stored at 10-30℃, valid for 18 months.

Opened: The cartridge must be used within 1 hour once its foil pouch is opened.

【Warnings and precautions】

For in vitro diagnostic use.

The package insert must be carefully followed. Reliability of the test results cannot be guaranteed if there are any deviations from the package insert.

Safety precautions

CAUTION: This product requires the handling of human samples. It is recommended that all human sourced materials are considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 211 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents.

Appropriate protective measures should be taken in the collection, processing, storage, mixing of the sample and testing process; once the sample and the reagent contact skin, wash with plenty of water; if skin irritation or rash occurs, get medical advice/attention.

Samples, used cartridge and disposable tips may be potentially infectious. Proper handling and disposal methods should be established by the laboratory in accordance with local regulations.

Handling precautions

Do not use the kit beyond the expiration date. The production date and expiration date are on the label.

Different batches of sample diluent, calibration cards and cartridges cannot be mixed.

The cartridge is disposable and cannot be reused.

Please do not use obviously damaged kit or cartridge.

Do not insert the cartridge wetted by other liquids into the analyzer, in order not to damage and pollute the instrument.

Please avoid high temperature in the lab.

The calibration card and immunofluorescence quantitative analyzer should keep away from vibratile and electromagnetic environment when used. Slight vibration of the instrument is normal. Do not pull out the cartridge during testing.

To avoid contamination, wear clean gloves when operating with kits and samples.

For a detailed discussion of handling precautions during system operation, refer to the NORMAN service information.

【Specimen collection and preparation】

The whole blood are advised to use EDTA anticoagulant tube, and the sample is advised to be tested immediately. If not, store the whole blood sample at 2-8℃, and complete the test within 24 hours. Heat inactivated and hemolysis samples should be abandoned.

The samples must reach room temperature(10-30℃) before the test. The cryopreserved sample can only be used after complete melting, rewarming and mixing. Avoid repeating freezing and thawing samples.

【Procedure】

Preparation

Installation of the immunofluorescence quantitative analyzer（NRM-FI-1000）and reagent strip incubator

Please read the operator’s manual of the immunofluorescence quantitative analyzer（NRM-FI-1000）and reagent strip incubator carefully before us

Calibration Card installation

Each box contains a lot-specific Calibration Card to correct for lot-to-lot deviation.

Turn on the power switch, according to the system self-test prompt, waiting for the instrument to display the main interface.

Press “Assay Management”.

Insert the Calibration Card into the card slot following the direction of the arrow, then press “Read". Confirm the lot number of the Calibration Card with the reagent relevant information, then press "Ok".

Press “Return” to the main interface.

Cartridge

Cartridge needs to reach room temperature before opened.

Test procedure

Remove the cartridge (after reaching room temperature), draw in 10μL of the sample to sample diluent. After gently mixing the sample, add 90μL into the well and incubate it for 5 minutes in the reagent strip incubator.

After incubation insert the cartridge into the immunofluorescence quantitative analyzer（NRM-FI-1000） using the cartridge arrows as a guide, and click start, then the instrument will scan the cartridge automatically.