Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
FPSA
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Free Prostate Specific Antigen (FPSA) Rapid Quantitative Test(Fluorescence Immunoassay)
【Product name】tPSA.pdf
Free Prostate Specific Antigen (FPSA) Rapid Quantitative Test(Fluorescence Immunoassay)
【Package specification】
25 Tests/kit
【Intended use】
This kit is used for quantitative determination of FPSA 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.
【Test principle】
The FPSA 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 FPSA monoclonal antibody, then moved and combined with another FPSA 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 analyzer.
【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 |
he 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.
【Interpretation of results】
Gastrointestinal | ||||||
cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
36 | FOB | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
37 | TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
38 | FOB+TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
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