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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.
|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. 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.
WWHS NIR-1000 dry fluoroimmunoassay analyser
Why Choose WWHS
Our company's main business is INFRARED fluorescent POCT. The main application scenarios of POCT include emergency department, ICU, chest pain center and stroke center, operating room, and various departments of grade hospitals. Community health, outpatient and other primary medical institutions at all levels; Pharmacies, home use and other organizations and individuals targeted at end customers. POCT is characterized by its simplicity and speed, freedom from application scenarios, and high cost performance. However, the current pain point of POCT industry lies in how to solve the problems of low sensitivity and poor precision faced by POCT products.
Wide-Range Diagnostics, It can be used in following areas
1) Department of thoracic Surgery
2) Clinical Laboratory
3) Department of Emergency
4) First Aid Community Hospital
5) Department of Respiration
7) Department of cardiology
8) Department of Geriatrics
Simple Procedure To Operate
1) Sample Can Be Plasma&whole Blood
2) Choose Internal Or External According To Needs
3) Single&Batch Processing
only two simple steps: Add 100ul blood sample to the test strip and wait for 15 minutes, then insert the test strip into the device and get the results
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