INTENDED USE
The Prostate Specific Antigen (PSA) is a rapid visual immunoassay for the qualitative presumptive detection of prostate specific antigens in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of prostate cancer.
| Storage |
2~30 º C |
| Specimen |
Whole Blood/Serum/Plasma |
| Component |
Rapid Test + Buffer + Pipettes |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 15mins |
| Package |
40tests/box; 1test/box |
| Trademark |
Dewei |
| Origin |
China |
PRINCIPLE
The PSA Rapid Test 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.
MAIN CONTENTS
• Rapid test cassette with desiccant
• Buffer
• Package insert
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (15 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 1 drops of serum/plasma to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer, and start the timer.
OR
Transfer 2 drops of whole blood to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer, and start the timer.
OR
Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, then add 1 drop of buffer, and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
PRODUCT IMAGES
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CERTIFICATES
EXHIBITIONS
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