WWHS Biotech.Inc(exclusive marketed by Dawin) |
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【Product name】tPSA.pdf
Prostate Specific Antigen (PSA) Rapid Quantitative
Test(Fluorescence immunoassay)
【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】
【Procedure】
【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.
【Limitations of methods】
WWHS Assay list | ||||||
Tumor Maker | ||||||
cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended 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 |