WWHS Biotech.Inc(exclusive marketed by Dawin) |
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【Product name】
Carbohydrate Antigen 153(CA153)Rapid Quantitative Test(Fluorescence
immunoassay)
【Package specification】
25 Tests/kit
【Inspection principle】
The CA153 Rapid Test is a one-step chromatographic sandwich
immunoassay designed for the quantitative measurement of CA153. The
CA153 antigen in the sample was first bound with the conjugated
compound of fluorescent labeled CA153 monoclonal antibody, then
moved and combined with another CA153 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 analyser.
【Components】
Name | Quantity | Component |
Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled CA153 monoclonal mouse antibody), nitrocellulose membrane (coated with CA153 monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
Sample diluent | 25(300μL/tube) | Phosphate buffer |
ID card | 1 | With specific stand curve file |
【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 CA153 in the sample is less than 500U/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%.
【Procedure】
【Note】
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
WWHS Assay List
Tumor Marker | ||||||
cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
20 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
21 | CEA | Serum/Plasma | 15min. | 1-200ng/ml | <5ng/ml | colon cancer, colorectal cancer,etc. |
22 | NSE | Serum/Plasma | 15min. | 1-400ng/ml | <16ng/ml | non-small cell lung cancer |
23 | FOB | fecal specimens | 10min. | 50-1000ng/ml | <100ng/ml | Abnormal recessive gastrointestinal bleeding |
24 | PG II | Serum/Plasma | 15min. | 1-100ug/L | PGI/PGII>3.0 | gastric abnormalities |
25 | PG I | Serum/Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
26 | TPSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
27 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
28 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
29 | CA15-3 | Serum/Plasma | 15min. | 10-400U/ml | < 25 U/mL | breast cancer |
30 | HE4 | Serum/Plasma | 15min. | 50-2000pmol/L | <140 pmol/L | ovarian cancer |
31 | CA19-9 | Serum/Plasma | 15min. | 10-400U/ml | < 27 U/mL | pancreatic cancer |
32 | β-HCG | Serum/Plasma | 15min. | 5-400mIU/ml | <10 mIU/mL | Early pregrancy, ectopic HCG cancer,incomplete abortion |
33 | CK19(Cyfra21-1) | Serum/Plasma | 15min. | 0.5-50ng/ml | <2.5ng/ml | non-small cell lung cancer |
FAQ
1. What is fluorescent immunoassay analyzer?
The Biopanda Fluorescence Immunoassay Analyser is used by small
labs for the detection of a range of biomarkers to assist with the
diagnosis and monitoring of several medical conditions including
cardiovascular disease, inflammation, kidney disease, thyroid
conditions, and fertility.
2. Do you have CE certificate for immunoassay analyzer?
WBC analyzer belongs to IVD other/general, no need CE, Ec
declaration is enough.
3. How does fluorescence immunoassay work?
Fluorescent Immunoassays are simply a different type of
immunoassay. ... A modern fluorescent based immunoassay uses as the
detection reagent a fluorescent compound which absorbs light or
energy (excitation energy) at a specific wavelength and then emits
light or energy at a different wavelength.
4. What is indirect immunofluorescence assay?
Indirect immunofluorescence, or secondary immunofluorescence, is a
technique used in laboratories to detect circulating
autoantibodies in patient serum. It is used to diagnose autoimmune
blistering diseases.
5. Is immunofluorescence an immunoassay?
Immunofluorescence assay (IFA) is a standard virologic technique to
identify the presence of antibodies by their specific ability to
react with viral antigens expressed in infected cells; bound
antibodies are visualized by incubation with fluorescently labeled
antihuman antibody.