Diagnostic Kit for C-reactive Protein (Immunochromatographic assay)

Ⅰ.Test principle

Diagnostic Kit for C-reactive Protein is used the principle of fluorescence immunochromatography. The CRP antigen in the sample first combines with the fluorescent labeled CRP monoclonal antibody conjugate, and then continues to move and combine with another CRP monoclonal antibody fixed on the nitrocellulose membrane to form a double antibody sandwich immune complex at the detection line of nitrocellulose membrane.

Ⅱ.Product Description

Intended use:Diagnostic Kit for C-reactive Protein 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.

Ⅲ.Using the step

1. Before the test, please read the instructions completely. If Diagnostic Kit for C-reactive Protein 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 and correctly select the corresponding sample type on the instrument.

3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.

4. Take out the test card from the aluminum foil bag and use it within 15 minutes.

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

6. Mix 5 µL of sample with 1000µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.

7. At 3 minutes after addition of samples, insert the test card into NIR-1000 dry fluoroimmunoassay analyser and click the “Instant test” button to read the results.

Ⅳ.Sample requirements

1. Serum and EDTA•Na2 anticoagulant plasma and whole blood, EDTA•K2 anticoagulant plasma and whole blood, sodium citrate anticoagulant plasma and whole blood can be used.

2. Venous blood was collected according to routine laboratory methods, and hemolysis was avoided as much as possible in the process of treatment.

3. After clinical samples were collected, the detection was completed within 4 hours at room temperature (15-30) ℃.The whole blood sample can be stored for 24 hours at (2-8)℃ without freezing; Serum and plasma samples can be stored for 7 days at 2-8℃;Serum and plasma samples -20℃ for 30 days.

4. The sample must return to room temperature (15-30)℃ before testing. The frozen samples should be completely thawed, rewarming and mixed evenly before use, and repeated freezing and thawing should be avoided.

5. Do not test samples with severe hemolysis, severe lipidemia and jaundice.

Ⅴ.CRP-hsCRP.pdf