High Sensitivity PSA Rapid Test Kits POCT IVD Tumor Marker Detection
Brand Name:WWHS
Certification:ISO 13485, CE
Model Number:PSA
Minimum Order Quantity:1000
Delivery Time:10 Days
Payment Terms:L/C, T/T
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Shenzhen China
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Product Details
【Product name】 tPSA.pdf
Prostate Specific Antigen (PSA) Rapid Quantitative
Test(Fluorescence immunoassay)
【Remark】
1, Room temperature store and transport, shelf life 12 months.
2,After dissolved, should store at -20℃, shelf life 1 month.
3,Each unit for 10 tests.
【Components】
Name Quantity Component
Test cards 25 It is composed of fluorescent pad (coated with
fluorescent labeled PSA monoclonal mouse antibody), nitrocellulose
membrane (coated with PSA 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.
【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 100 µL of patient sample with 300µL of sample diluent. Apply
100 µL 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 10 minutes after addition
of samples, then dispose of used test appropriately.
【Reference interval】
Healthy males are expected to have serum PSA values below 4ng/mL.
However,as PSA levels increase with age, the use of age-specific
reference ranges has been suggested in order to increase the
sensitivity in younger men and increase the specificity in older
men. Each laboratory must establish its own normal ranges based on
the representative local population.
【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 PSA concentration lower than 2ng/ml and higher
than 100ng/ml, the detection results are reported as "< 2ng/ml"
and "> 100ng /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 PSA in the sample is less than
20000ng/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%.
【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.
High Sensitivity PSA Rapid Test Kits POCT IVD Tumor Marker Detection
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