INTRODUCTION One Step PSA Rapid Screen Test is a rapid direct binding immunoassay in-vitro diagnostic (IVD) test for the qualitative detection of Prostate Specific Antigen (PSA) tumor markers in human Whole Blood. PSA tumor marker tests are based on the principle of sandwich immunoassay for determination of PSA in human Whole Blood. Two monoclonal antibodies are employed to identify cancer PSA specifically. The prostate specific antigen (PSA) is the most commonly tested tumor marker for the prostate gland disease diagnosis. PSA tumor marker is normally present in low levels in the blood of all adult men. In human blood, the normal concentration range of this biomarker is 0.0 to 4.0 ng/ml, which are variable among different human races (refer to the table at the end of this page). But when prostate specific antigen rise beyond the normal range, it can be taken as a signal of prostate gland cancer or other problems. That is why PSA becomes the subject of PSA Whole Blood detection devices.
PRINCIPLE The PSA Rapid Test Device (Whole Blood/Serum/Plasma) detects prostate specific antigens through visual interpretation of color development on the internal strip. PSA antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with PSA antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient PSA in the specimen, a colored band will form at the test region of the membrane. A test band (T) singal weaker than the reference band (R) indicates that the PSA level in the specimen is between 4-10 ng/mL. A test band (T) signal equal or close to the reference band (R) indicates that the PSA level in the specimen is approximately 10 ng/mL. A test band (T) signal stronger than the reference band (R) indicates that the PSA level in the specimen is above 10 ng/mL. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred
SPECIMEN COLLECTION For whole blood, collect blood into a container with anticoagulant. If the specimen cannot be tested on the day of collection, store the whole blood specimen in a refrigerator. Bring the specimens to room temperature before testing.
TEST PROCEDURE 1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour. 2. Place the test device on a clean and level surface. Be sure to label the device with specimen’s ID number. 3. Hold the dropper vertically and transfer one drop of whole blood to the specimen well (S) of the test device. 4. Add 50 ul of fresh blood to the Sample Well (for Card) or Sample Pad (for Dipstick),Then add 2 drops (50 ul) of test running buffer into the sample well or sample pad. 5. Wait for the red line(s) to appear. The result should be read in 10-15 minutes. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS Negative: Only one colored band appears on the control (C) region. No apparent band on the test (T) region. Positive:Two pink bands appear on test region of the Cassette. This indicates that the specimen contains PSA Invalid: If without colored band appears at control region, this is an indication of a possible error in performing the test. The test should be repeated using a new one.
STORAGE AND STABILITY The test kits can be stored at room temperature (2 to 30C) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.
PRECAUTION 1. For in vitro diagnostic use only. 2. Do not use test kit beyond the expiry date. 3. The test device should not be reused.