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CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette

CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette

CA15-3 IVD Rapid Test Kit

POCT Diagnostic Reagent Cassette

IFA Colloidal Rapid Test Kit

Place of Origin:

CN

Brand Name:

WWHS

Certification:

CE

Model Number:

CA15-3

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Product Details
Product Name:
CA15-3 Rapid Test Kit
Usage:
Tumor Markers
Reactivity:
Human
Formal Name:
Carbohydrate Antigen 153
Storage:
4-30℃
Manufacturer:
WWHS Biotech INC
Advantage:
High Sensitivity
Throughput:
2000 Tests/Day
Format:
Cassette
Application In:
WWHS NIR-1000 Dry Fluoroimmunoassay Analyser
Annual Capacity:
5 Million A Year
Payment & Shipping Terms
Minimum Order Quantity
1000
Price
US 1.50 - 2.50 Kit
Packaging Details
Colorful Paper Box
Delivery Time
7 Days
Payment Terms
T/T
Supply Ability
30000 Kits per Week
Product Description

【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.

CA153 is a glycoprotein secreted by breast cancer cells that can be measured. While the level of CA153 is rarely elevated in patients with early stage or localized cancer, the majority of patients with metastatic breast carcinoma (MBC) have elevated serum level of CA153. An Italian group has reported that serum CA153 could be an independent prognostic factor for survival and recurrence in addition to visceral metastases. CA 27-29, the other type of assay measuring MUC1 gene-derived glycoprotein, may have clinical utility in assessing the response to treatment. Indeed, some reports show comparable results between CA27-29 and CA153. It is also known that CA153 in combination with CA 27-29 has improved sensitivity, especially in patients with metastatic bone lesions. CEA is also associated with various malignancies, including cancer of the breast, colon, and lung. The low sensitivity of the CEA assay when compared with the CA15-3 measurement, however, reduces the value of CEA in breast cancer management.

The American Society of Clinical Oncology (ASCO) guidelines recommend combining CA153 with imaging and a physical examination for monitoring patients with MBC because current data are insufficient to recommend the use of CA153 alone for monitoring the response to treatment. In the absence of measurable lesion(s), however, an increasing CA153 level may be used to indicate treatment failure. Caution is necessary when interpreting a rising CA153 level during the first 4–6 weeks of a new therapy, since spurious early rises may occur. The transient CA153 elevations induced by chemotherapy followed by a decrease (the CA153 surge) may result in inappropriate early discontinuation or change of chemotherapy.

In the current study the incidence of the CA153 surge and its relevance to the clinical characteristics and outcomes in patients with MBC treated with chemotherapy were determined. It was also evaluated that the usefulness of the serum CA153 kinetics using receiver operating characteristic (ROC) curves in monitoring chemotherapy response in patients with MBC.

【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.

【Storage conditions and validity】

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.

The production date, batch number and expiration date are shown in the outer package of the product.

【Applicable instruments】

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

【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.

【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.

【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%.

【Performance】

1. Limits of detection

No more than 10U/ml.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (10-400U/ml), the linear correlation coefficient R≥0.990.

【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.

 

CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette 0CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette 1

 

Note:


1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay

 

Assay list  Tumor Marker        
cat#. Product Item Specimen Reaction Time Measure Range Clinical Range Intended 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 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette 2CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette 3CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette 4CA15-3 IVD Rapid Test Kit IFA And Colloidal Gold POCT Diagnostic Reagent Cassette 5

 

FAQ:

 

1. What is the MOQ?

 

Generally if you choose the different products, our minimum order qty. also will be different. One sample available.

 

2. What about the delivery time?

 

The goods need 7-21 work days to be made upon deposit.

 

3. Does your product have any warranty?

 

Yes, we offer 6 months limited warranty for our products.

 

Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.

 

4. What's your shipping method?

 

We provide comprehensive shipping methods.

 

For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.

 

For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.

 

Disclaimer

 

While every efforts were made to ensure the accuracy of the information provided in this datasheet, FIA POCT will not be liable for any omissions or errors contained herein. FIA POCT reserves the right to make changes to this datasheet at any time without prior notice.

 

All of WWHS's Products are for scientific laboratory research purposes and diagnostic, therapeutics analysis, and are not for prophylactic or in vivo use. Through your purchase, you expressly represent and warrant to WWHS that you will properly test and use any Products purchased from WWHS in accordance with industry standards. WWHS and its authorized distributors reserve the right to refuse to process any order where we reasonably believe that the intended use will fall outside of our acceptable guidelines.

 

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