Wide Range Diagnostics PSA Rapid Test Kit 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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Location:
Shenzhen China
Address:
Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen
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Product Details
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Product Details
【Product name】
Prostate Specific Antigen (PSA) Rapid Quantitative
Test(Fluorescence immunoassay)
【Package specification】
25 Tests/kit
【Intended use】
This kit is used for quantitative determination of PSA in human
whole blood, plasma and serum.
Human prostate-specific antigen (PSA) is a serine protease, a
single chain glycoprotein with a molecular weight of approximately
34,000 daltons containing 7% carbohydrate by weight. In human
serum, PSA exists in at least 3 different forms: free, alpha
1-antichymotrypsin (PSA-ACT) and alpha 2-macroglobulin (PSA-AMG).
Only free PSA and PSA-ACT can be detected with available
immunoassays. Elevated serum PSA concentrations have been reported
in patients with prostate cancer, benign prostatic hypertrophy,
prostatitis or inflammatory conditions of other adjacent
genitourinary tissues. Also, increases in PSA to 4-10 ng/mL are not
uncommon among men with benign prostatic hyperplasia (BPH) or
prostatitis. The determination of PSA serum levels is not only
important for the screening of patients for prostate cancer, but
also for monitoring patients that have been treated for this
disease.
【Inspection principle】
The PSA Rapid Test is a one-step chromatographic sandwich
immunoassay designed for the quantitative measurement of PSA. The
PSA antigen in the sample was first bound with the conjugated
compound of fluorescent labeled PSA monoclonal antibody, then moved
and combined with another PSA 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 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.
【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 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%.
【Performance】
1. Limits of detection
No more than 0.5ng /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 (2 ~ 100ng/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.
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.
Applicable Instrument
WWHS NIR-1000 dry fluoroimmunoassay analyser
Quality Control
A procedural control is included in the test. A colored line
appearing in the control region (C) is the internal procedural
control. It confirms sufficient specimen volume and correct
procedural technique.
Control standards are not supplied with this kit; however, it is
recommended that a positive control and a negative control control
be tested as a good laboratory practice to confirm the test
procedure and to verify proper test performance.
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 payment method?
We usually accept the payment methods include PayPal, TT, and Western Union.
50% deposit in advance and balance before shipping. Buyer can choose which payment ways that you accept.
PayPal is most useful and safe, please don’t refuse PayPal fee when you choose PayPal.
5. 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.
Wide Range Diagnostics PSA Rapid Test Kit POCT IVD Tumor Marker Detection
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