CK-MB Rapid Quantitative Test Kit WWHS FIA POCT Fluorescence Immunoassay

【Product name】

Creatine Kinase Isoenzyme MB (CK-MB) Rapid Quantitative Test (Fluorescence immunoassay)

【Packing specification】

25 Tests/kit

【Components】

The components in different batches of CK-MB Rapid Quantitative Test Kits cannot be used interchangeably.

【Applicable instrument】

Mod:NIR-1000 Dry Fluoroimmunoassay Analyser produced by WWHS Biotech.Inc.

【Sample requirements】

1. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.

2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.

3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃ for 30 days.

4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.

【Reference interval】
   The normal reference value is less than 5ng/mL in this assay. It is strongly recommended that each laboratory should determine its own normal and abnormal values.

【Limitation of rest method】

1. CK-MB Rapid Quantitative Test Kit is only used to detect human plasma/ serum and whole blood samples.

2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.

3. The content of triglyceride in the sample shall not exceed 10mg/mL, the content of hemoglobin shall not exceed 10mg/mL, and the content of bilirubin shall not exceed 0.5mg/mL, and the relative deviation of the test results shall not exceed ±15%.

4. When the concentration of CK-MB in the sample is less than 300.00ng/mL ,there is no hook effect.

5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.

6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±10.0%.

【Precautions】

1. CK-MB Rapid Quantitative Test Kit can be used for in vitro diagnosis only.

2. Test card and buffer solution are single-use and they cannot be reused.

3. Please check the integrity and validity of the CK-MB Rapid Quantitative Test 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. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place CK-MB Rapid Quantitative Test Kit in the air for a long time to avoid dampness.

5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.

6. CK-MB Rapid Quantitative Test Kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.