【Intended use】

D-Dimer Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of D-Dimer in human plasma. D-Dimer is a good index of active cellulose dissolution. It is of diagnosis value in diseases caused by thrombosis such as disseminated intravascular coagulation (DIC), deep vein thrombosis, pulmonary embolism, cerebrovascular disease, liver disease, acute myocardial infarction after the surgery, gynecology, pediatrics and other diseases. At the same time, D-Dimer detection can also be used as an index in the treatment of thrombolytic drug.

【Test principle】

The assay is a double-antibody sandwich immunoassay for quantitative determination of D-Dimer concentration based on immunofluorescence technology. Add the sample to the sample well of the cartridge. Through chromatography, the sample reacts with the fluorescent latex particles coated with D-Dimer monoclonal antibody Ⅰ on the conjugate pad. The complex spreads ahead along the nitrocellulose membrane captured by D-Dimer monoclonal antibody Ⅱ on the test line. The more D-Dimer the sample contains, the more complexes the test line accumulates. The intensity of fluorescent antibody signal reflects the amount of captured D-Dimer. The immunofluorescence quantitative analyzer produced by our company can detect the concentration of D-Dimer in the sample.

【Package】

25 Tests /Box

【Materials provided】

25 D-Dimer sample diluent

One cartridge contains:

Diluent:

Phosphate buffer (10mmol/L), etc. pH=7.4±0.2.

【Accessories required but not provided】

     Immunofluorescence quantitative analyzer（NRM-FI-1000）

     Reagent strip incubator

     Pipette

    D-Dimer Control

【Storage and stability】

Sealed: The kit must be stored at 10-30℃, valid for 18 months. The sample diluent 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. The sample diluent is valid for 1 month once it is opened.

【Warnings and precautions】

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 reagents, 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 reagent kits and samples.

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

【Specimen collection and preparation】

Plasma sample is advised to use 1:9 citrate tubes to collect and the sample is advised to be tested within 4 hours. If not, store the sample 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 plasma, 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 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 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 90μL of plasma sample to D-Dimer sample diluent. After gently mixing the sample, add 90μL of diluted sample into the sample well and incubate it for 10 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 D-Dimer higher than the limit of the kit of 10mg/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 20mg/L.

Result analysis

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