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CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker

CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker

  • CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
  • CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
  • CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
  • CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
  • CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
  • CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: ISO 13485, CE
Model Number: CA153
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: US 1.50-2.50 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 10 Days
Payment Terms: L/C, T/T
Supply Ability: 30000 Kits per Week
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Detailed Product Description
Product Name: Carbohydrate Antigen 153 POCT Package: 25 Tests
Warranty: 12 Months Manufacturer: WWHS Bio INC
Reactivity: Human Feature: High Sensitivity
Storage: 4-30℃ Advantage: High Accuracy
Application: Tumor Maker Detection Throughput: 3000 Tests/Day
Vitro Diagnosis: Pathological Examination
High Light:

CA15-3 Antigen Rapid Test Kit

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3000 Tests/Day Antigen Rapid Test Kit

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IVD Tumor Marker

【Product name】
Carbohydrate Antigen 153(CA153)Rapid Quantitative Test(Fluorescence immunoassay)
 
【Package specification】
  25 Tests/kit
 
【Intended use】
  This kit is used for quantitative determination of CA153 in human whole blood, plasma and serum.
 
【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

 
 


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

 
【Applicable instruments】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

 

【Reference interval】

Healthy female are expected to have assay values below 25U/mL. However,it is strongly recommended that each laboratory should determine its own normal and abnormal values.

 

【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 CA153 concentration lower than 10U/ml and higher than 400U/ml, the detection results are reported as "< 10U/ml" and "> 400U/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 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】

  1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
  2. Start NIR-1000 dry fluoroimmunoassay analyser according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
  3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
  4. Place the test card on a clean horizontal table and mark it horizontally.
  5. Mix 100µL of patient sample with 300µL of sample diluent. Apply 100µL of diluted samples to the well of the test card.
  6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 15 minutes after addition of samples, then dispose of used test appropriately.

 

 【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

 
CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 0CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 1
CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 2CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 3CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 4
CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 5CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 6CA15-3 Antigen Rapid Test Kit 3000 Tests/Day IVD Tumor Marker 7
 

 
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.
 

Contact Details
WWHS Biotech.Inc(exclusive marketed by Dawin)

Contact Person: sales

Tel: +8613823276027

Send your inquiry directly to us (0 / 3000)

Contact

Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen