CA153 Tumor Marker Rapid Test Kit 20T WWHS FIA POCT Assay
Brand Name:WWHS
Certification:ISO 13485, CE
Model Number:CA153
Minimum Order Quantity:1000
Delivery Time:7 Days
Payment Terms:L/C, T/T
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Product Details
【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.
| 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 |
CA153 Tumor Marker Rapid Test Kit 20T WWHS FIA POCT Assay
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