WWHS Whole Range CRP FIA Rapid Quantitative Test Kit POCT IVD 25T Assay

【Product name】

Diagnostic Kit for C-reactive Protein (Immunochromatographic assay)

【Package specification】

25 Tests/kit

【Intended use】

It is used for quantitative detection of C-reactive protein (CRP) in human serum, plasma and whole blood. CRP is mainly used as a non-specific inflammatory index.

【Main components】

The components in different batches of kits cannot be used interchangeably.

【Storage conditions and validity period】

4℃ - 30℃, dry, dark, no freezing, sealed in aluminum foil bag, valid for 18 months. The test card should be returned to room temperature (15-30)℃ before use, and should be used within 15 minutes after unsealing under the environment of temperature (15-30) ℃ and relative humidity (20% - 90%).

The production date, batch number and expiration date are shown in the outer package of the product.

【Test procedure】

1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.

2. Start NIR-1000 dry fluoroimmunoassay analyser according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the ID card. The test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)

3. Remove the test card from the aluminum foil bag and use it within 15 minutes.

4. Place the test card on a clean horizontal table and mark it horizontally.

5. Add 5μL sample to sample diluent (1500μL), mix well and add 100μL diluted sample to the sampling hole.

6. Insert the test card into dry fluoroimmunoassay analyser, press the “timing test” key, automatically time for 3 minutes, automatically judge the test results, and display the quantitative results on the screen. Or insert the test card into the analyzer after 3 minutes, and press the “Instant test” key, and the instrument will automatically interpret the results.

【Performance】

1. Detection limit: No higer than 0.5mg/L.

2. Accuracy: the relative deviation from the target value is not more than±10%.

3. Repeatability: coefficient of variation (CV) should be no more than 10%.

4. Inter batch difference: the relative range (R) between batches should be no more than 15%.

5. Linear range: within the specified linear range of 0.5mg/l-200mg/l, the linear correlation coefficient R ≥ 0.990.The absolute deviation of the linear range in [0.5-5] mg/L is not more than ±5 mg/L, the linear range is (5-200] mg/L, the relative deviation is less than±10%.

【Note】

1. The kit is only used for in vitro diagnosis.

2. The test card is disposable and cannot be reused.

3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15-30) ℃ before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.

4. The test card should be taken out from the aluminum foil bag and tested within 15 minutes to avoid being placed in the air for a long time and causing damp.

5. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.

6. The kit contains products from animals. The qualified information of animal source and health status cannot guarantee the existence of infectious pathogens. Therefore, it is suggested that these products should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.

7. Hematocrit too high or too low may affect the results of whole blood test, it is recommended to use other detection methods for verification.