PSA For Quantitative Determination In NIR-1000 Single Channel IVD POCT Device

【Product name】35. tPSA.pdf

Prostate Specific Antigen (PSA) Rapid Quantitative Test(Fluorescence immunoassay)

【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.

【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.