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Ferritin(Fer)Kit

Ferritin (Fer) Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of Ferritin (Fer) content in human. 
  • Brand:

    Norman
  • Payment:

    T/T
  • Specification:

    1/25 Tests
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  • Product Detail

Intended use
Ferritin (Fer) Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of Ferritin (Fer) content in human. Ferritin is a soluble tissue protein in the body that stores iron, and normal people's blood contains a small amount of ferritin. Ferritin is the storage form of iron, and its content changes can be used as an indicator to determine whether iron is deficient or iron overload is excessive. Ferritin testing is suitable for understanding the state of iron metabolism in the body. The detection of ferritin in the early stage of treatment can reflect the reserves of iron in the body at that time, and the deficiency of iron storage in the woven endothelial system can be detected early. If the ferritin level is high, and the possibility of abnormal iron supply is removed, which reflects the condition of iron overdose in the body. The common detection methods in Clinic are Turbidity method, Immunofluorescence method, colloidal gold method and Chemiluminescence method.


Test principle

The assay is a double-antibody sandwich immunoassay for quantitative determination of Fer 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 ferritin monoclonal antibody I on the conjugated pad. The complex spread forward along the nitrocellulose membrane captured by the ferritin monoclonal Antibody II, which was fixed on the test line. The more ferritin there is in the sample, the more complexes are accumulated on the test line. The intensity of the fluorescent antibody signal reflects the amount of ferritin captured. The concentration of ferritin in the sample can be determined by the Immunofluorescence quantitative analysis instrument produced by the company.


Package

25 Tests /Box


Sample Type

Serum


Materials provided

Contents
25   Cartridges
1     Calibration Card
25   Sample diluents
25   Disposable tips


Accessories required but not provided

Immunofluorescence quantitative analyzer(NRM-FI-1000)
Reagent strip incubator

Fer 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 . 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 serum must be collected by standard tubes or pro-coagulation tube filled inside with separation gel. The sample is advised to be tested immediately. Serum should be stored at 2-8℃; If testing is delayed more than 24 hours, then store the sample at -20℃ or below.
Heat inactivated and hemolysis samples should be abandoned. If there is precipitation in the serum, centrifugation must be done before testing.
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 analyzerNRM-FI-1000and reagent strip incubator
Please read the operator’s manual of the immunofluorescence quantitative analyzer(NRM-FI-1000)and reagent strip incubator carefully before use.


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 30μL of the sample to sample diluent. After gently mixing the sample, add 90μL into the well and incubate it for 15 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.


Caution

Please check the direction of the cartridge before insertion and assure the insertion is correct.


Dilution

If a sample with Fer higher than the limit of the kit of 1000μg/L and a definitive result is required, the sample should be manually diluted with normal saline and then re-assayed according to the test procedure. The maximum valid dilution ratio is 2 times, the detection limit is 2000μg/L.


Result analysis

The analyzer automatically calculates the Fer concentration in each sample by means of a calibration curve. The results are expressed inμg/L. For further information please refer to the operator’s manual of Immunofluorescence quantitative analyzers (NRM-FI-1000).


Explanation of results

The test result is only for reference and it should be considered comprehensively in conjunction with clinical symptoms, health history and other laboratory test, etc. The result cannot serve as a sole factor of clinical diagnostic.

All operation must be in strict accordance with operating procedures to get the correct result. The accuracy of test results may be affected by any changes to operational procedures.


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