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Carbohydrate Antigen 153(CA153)Rapid Quantitative Test(Fluorescence immunoassay)
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.
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.
|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.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
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】
【Limitations of methods】
1. Limits of detection
No more than 10U/ml.
The relative deviation from the target value is within ±15%.
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.
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.
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|
|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|
|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|
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.
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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