Free Prostate Specific Antigen (FPSA) Rapid Quantitative Test（Fluorescence Immunoassay)

                                    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】

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】

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.

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