CYFRA21-1 CK19 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT

Product Name

Cytokeratin Fragment 19 (Cyfra21-1) Rapid Quantitative Test (Fluorescence immunoassay)

Packing Specification

25 Tests/kit,40 Tests/kit

Intended Use

The kit is used for quantitative determination of Cyfra21-1 in human serum, plasma and whole blood.

Cyfra21-1 is a member of a family of at least twenty different cytokeratin polypeptides. Cytokeratins form the intermediate filament structure of epithelial cells. Cytokeratin filaments are poorly soluble but following proteolytic degradation,soluble cytokeratin fragments are formed and released into body fluids. Cyfra21-1 is an immunoassay that determines the level of cytokeratin 19 fragments in serum or plasma . The CYFRA21-1 Rapid Test is based on two monoclonal antibodies specific for cytokeratin19. Elevated levels of cytokeratin 19 fragments are seen in serum or plasma from patients with lung cancer and also in other cancers eg.bladder cancer. The most important indication for Cyfra21-1 is for monitoring the course of disease in non-small cell lung cancer.

Inspection principle

The Diagnostic Kit for Cyfra21-1 is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of Cyfra21-1. The Cyfra21-1 antigen in the sample was first bound with the conjugated compound of fluorescent labeled Cyfra21-1 monoclonal antibody, then moved and combined with another Cyfra21-1 monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyzer.

Components

The components in different batches of kits cannot be used interchangeably.

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.

Importance of IVD

The importance of in vitro diagnosis in life and health is mainly reflected in that no matter healthy people, asymptomatic and symptomatic people and people with chronic diseases are inseparable from diagnostics, and diagnosis runs through the whole medical cycle. In particular, modern medicine has entered the era of precision medicine, and the core of precision medicine is accurate diagnosis.



WWHS POCT Assay List

Interpretation of results
1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/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 15mg/ml, the content of hemoglobin shall not exceed 5mg/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 AFP in the sample is less than 20000ng/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 in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
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Applicable Instrument

WWHS NIR-1000 dry fluoroimmunoassay analyser

As A Fast-Growing Biotechnology Company, WWHS Biotech.Inc(exclusive marketed by Dawin) Dedicate To The Development Of World-Class Bio-Detection Technologies That Meet The Ever-Increasing Demands On Clinical Diagnostics. We Focus On Developing Cost-Effective And Precise Rapid Diagnostic Products Based On Our Unique Near Infrared (NIR) Fluorescence Platform Technologies (PGOLD™ And IR-LF™) With Major Interests In Cardiology, Infectious Diseases, Oncology, Metabolic Diseases And Women And Children’s Health...