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C Reactive Protein /Serum amyloid A (SAA)Determination 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
For the quantitative detection of C-Reactive Protein/Serum Amyloid A (CRP/SAA) in human serum, plasma or whole blood. They are for professional use only.
PRINCIPLE
After the diluted sample is added dropwise to the sample wells of the detection reagent, serum amyloid A and C-reactive protein in the sample combine with fluorescently labelled anti-serum amyloid A（SAA）monoclonal antibody I and C-reactive protein（CRP） monoclonal antibody I to form an immune-reactive complex, which moves forward along the nitrocellulose membrane and is captured by anti-serum amyloid A （SAA）monoclonal antibody II and anti-C-reactive protein monoclonal antibody（CRP） II, which are in the detection area of the nitrocellulose membrane, respectively, forming a detection signal. II and anti-C-reactive protein （CRP） monoclonal antibody II, respectively, captured, forming a detection signal, the formation of the detection signal in the sample of the more substances to be measured, the more complexes accumulated on the detection line, the intensity of the fluorescent signal reflects the content of the captured substances to be measured. At the end of the reaction, the amount of the substance to be measured in the sample can be measured by the dry fluorescence immunoassay analyser. Fluorescently labelled antibodies not captured in the detection zone move forward along the nitrocellulose membrane and bind to the quality control antibody in the quality control area to form a quality control signal.
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-serum amyloid A monoclonal antibody, anti-C-reactive protein monoclonal antibody, and chicken IgY), a nitrocellulose membrane (C-wire wrapped with the quality control antibody, anti-serum amyloid A antibody, and anti-C-reactive protein antibody), a sample pad, an absorbent paper and PVC plates. Diluent solution: composed of phosphate, preservative, etc., pH=7.4.
REFERENCE VALUE
C-reactive protein reference interval range: ≤10mg/L;
Serum amyloid A reference interval range: ≤10mg/L.
Note: Due to differences in geography, ethnicity, gender, and age and diet, it is recommended that each laboratory establish its own reference interval.
LIMITATIONS
1. This kit is intended for the detection of human whole blood, serum and plasma only, other body fluids and samples may give inaccurate results.
2. The results of this test are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases.
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 in the blood with similar antigenic determinants.
4. Possible reasons for false-negative results: some unknown components shield the antigenic determinants so that they cannot bind to the antibody; serum amyloid A and C-reactive protein antigens are gradually degraded and cannot be recognised by the antibody with the prolongation of the sample's storage time and the rise of external temperature; unreasonable sample collection, transfer and processing, and too low a concentration of the substance to be measured in the sample may all lead to false-negative results.
5. The operation must be carried out in strict accordance with the operating procedures and with great care in order to obtain correct results, and any modification of the operating procedures may affect the results.
APPLICABLE INSTUMENT
1.MKF-101 fluorescent immunoanalyzer
2.MKF-201 Portable dry fluorescence immunoassay analyzer
3.MKF-202 fluorescent immunoanalyzer
关键词:
CRP
SAA
TEST KIT
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