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CRP Quantitative test Kit
● Instrumentation:
MKF-101 fluorescent immunoanalyzer
MKF-201 Portable dry fluorescence immunoassay analyzer
MKF-202 fluorescent immunoanalyzer
● Detection time: 5 minutes
● Storage: Room temperature (4-30°C)
● Shelf life: 24 months
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INTENDED USE
This Kit is intended for the in vitro quantitative determination of Hypersensitive C-reactive protein (hs-CRP) and conventional C-reactive protein (conventional CRP) in human whole blood/plasma.
C-reactive protein is a kind of acute phase reaction protein, which is very low in the concentration of healthy people, and rises sharply when the body is infected and tissue is damaged. C-reactive protein is a marker of inflammation and tissue damage, and its elevation is related to the degree of infection. It can be used for the detection of routine inflammation and cardiovascular inflammation, providing information on the diagnosis, treatment and monitoring of inflammatory diseases.
PRINCIPLE
CRP Quantitative test Kit uses a immunofluorescence double antibody sandwich method to detect concentration of C-reactive protein.
When the appropriate amount of test samples treated with dilution buffer is added to the sample well of the test cassette, the sample will move forward along the test strip by capillary action. If the sample contains C-reactive protein, and the concentration is higher than the limit of detection, the C-reactive protein will form immune complexes with corresponding CRP monoclonal antibody I labeled with latex fluorescence, The reaction compound spreads forward along the nitrocellulose membrane and is captured by CRP monoclonal antibody II coated on the nitrocellulose membrane test line.
The more CRP in the sample, the more complex accumulated on the test line. Signal intensity of fluorescence on detector antibody reflects the amount of CRP captured. The concentration of CRP in sample can be detected by analyzer.
MAIN COMPONENTS
The kit contains the corresponding number of test cassettes for each package specification: the test cassette consists of a test strip shell and a test strip, which consists of a binding pad containing fluorescent microsphere-labelled anti-CRP antibody and chicken IgY, a nitrocellulose membrane with a C-wire encapsulated quality control antibody and another anti-CRP antibody, a sample pad, absorbent paper and a PVC plate.
Diluent solution: composed of phosphate, preservative, surfactant, pH=7.4±0.2
Note: Components in kits of different lot numbers are not interchangeable.
INTERPRETATION OF RESULTS
1. Valid results
The instrument normally displays the value of the concentration of C-reactive protein in the sample;
In the absence of inflammation, hsCRP was used as a risk index assessment for cardiovascular disease:
2. Invalid result
The instrument interface displays C Line Error , indicating that the result is invalid. The test
cassette is invalid and the sample should be retested with a new card.
The test result can only indicate the level of C-reactive protein in whole blood, serum, plasma or peripheral blood, and cannot be used as the sole criterion for clinical diagnosis.
LIMITATIONS
1. This kit is designed for the detection of human whole blood, plasma, other body fluids and samples may get inaccurate results.
2. Triglycerides and total bilirubin in the samples will interfere with the results, and the maximum allow able concentrations are 20mM for triglycerides, 342μmol/L for total bilirubin, and 10g/L for hemoglobin, 100IU/mL Rheumatoid Factor (RF), 100ng/mL Human Anti-mouse Antibody (HAMA), 50U/L Antinuclear Antibody(ANA), respectively. High hook effect was not detected at CRP concentrations up to 500mg/L.
3. Possible reasons for false-positive results: cross-reactivity of similar antibody components in the blood; capture of fluorescently labelled antibodies by certain non-specific components of the blood with similar antigenic determinants.
4. Possible reasons for false-negative results: some unknown components shield the antigenic determinants from binding to the antibody; C-reactive protein degrades with time and temperature and cannot be recognised by the antibody; unreasonable sample collection, transport and handling, low concentration of the substance to be measured in the sample.
5. The operation must be carried out in strict accordance with the operating procedures and with great care in order to obtain the correct results, and any modification of the operating procedures may affect the results.
MATERIAL REQUIRED BUT NOT PROVIDED
Timer, centrifugal tube, pipette and disposable gun head.
APPLICABLE INSTUMENT
1.MKF-101 fluorescent immunoanalyzer
2.MKF-201 Portable dry fluorescence immunoassay analyzer
3.MKF-202 fluorescent immunoanalyzer
关键词:
CRP
Test kit
Quantitative test Kit
Hypersensitive C-reactive protein
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