Migi (dog) cCRP Canine C-reactive Protein Rapid Quantitative Test

Notice: You need an Immunofluorescence Analyzer to run the tests with this kit

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SPECIFICATION

10 Test/Box

Cat.No.:MG-CA-R001

INTENDED USE

The cCRP test is a fluorescence immunoassay used along with an Immunofluorescence Analyzer for the quantitative determination of cCRP concentration in canine whole blood, serum, or plasma specimens. The test is used as an aid to confirm the presence of underlying inflammation and monitor response to therapy and post-operative effects and recovery.

For in vitro diagnostic use only. For professional use only.

TEST PRINCIPLE

1. This test employs a quantitative double antibody sandwich fluorescence immunoassay technique.

2. The fluorescent signal intensity reflects the amount of cCRP captured. The concentration is expressed as mg/L.

MATERIAL

STORAGE AND STABILITY

1. Store the test kit at 4～30℃ up to the expiration date.
2. The test should operate at 18 ~ 28℃ after the Test Device opening.
3. Once the pouch is opened, the test should be performed within 30 minutes.

SPECIMEN COLLECTION AND PREPARATION

The test can be performed with either serum, plasma, or whole blood (Recommend the use of serum or plasma).

1. Collect the whole blood specimen into a collection tube (EDTA anticoagulant is recommended) by venipuncture. Or Separate serum or plasma from blood within 3 hours after blood collection. If a specimen appears to be severely hemolyzed, another specimen should be obtained and tested.
2. Optimally, the test should be performed immediately after the specimen collection. If the test cannot be performed within 3 hours after blood collection, store the specimen at 2～8℃ for no longer than 72 hours. For long-term storage, specimens shall be kept below -20℃.

Bring all materials to room temperature before use. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. Only clear, non-hemolyzed specimens can be used.

TEST PROCEDURE

Refer to the Immunofluorescence Analyzer Operation Manual for complete instructions for the use of the Test device.

1. Set a Test Device on a clean, level horizontal table.
2. Insert the ID Chip into the meter, and click “Read ID chip”. Make sure that the Test Device lot No. matches with ID Chip No.
3. Pipette 10μl of the prepared sample into cCRP Sample Buffer, and gently mix well. Vigorous agitation and foaming should be avoided.
4. Pipette 100 μl of mixed sample to add into the sample well (S) of the test device. Avoid forming bubbles.
5. Test mode: a or b

a) Standard Test: Click “Standard Test”, insert the Test Device into the device holder of the meter right after adding the sample to the sample well, click “Start Test”.Select Sample type “Whole blood” or “Serum/Plasma”. The meter will start to countdown and read the test result automatically.

b) Quick Test: Click “Quick Test”, and start the timer right after adding the sample mixture to the sample well. Leave the Test Device at room temperature (18 ~ 28℃) for 3 minutes. Then insert the test device immediately into the holder of the meter and click “Start Test”. Select Sample type “Whole blood” or “Serum/Plasma”. The instrument will scan the Test Device automatically and show the test result.

6. Results are displayed on the main screen, print automatically, or be printed by clicking “Print”.

QUALITY CONTROL

Each cCRP Rapid Quantitative Test contains an internal control for routine quality control requirements. This internal quality control is performed each time a patient sample is tested, If an invalid result from the internal control occurs, the meter will display an error message, indicating that another test should be conducted.

INTERPRETATION

Reference range of cCRP in canines either serum, plasma, or whole blood.

1. Detection range: 5~300 mg/L
2. Reference range:

Each laboratory should establish a reference range that is representative of the population to be evaluated.

WARNINGS AND LIMITATIONS OF THE PROCEDURE

1. This kit is for in vitro diagnostic use only.
2. Inspect the packaging and labels before use. Do not use it if the pouch is broken, torn, or not well sealed, or if the vial looks damaged or leaked.
3. Do not use the test device beyond the expiration date.
4. One pipette tip should be used for one specimen only.
5. There is the possibility that factors such as technical or procedural errors, as well as additional substances in blood specimens that are not listed in the text, may interfere with the test and cause erroneous results.