Complaint
Intended Use of PSA Rapid Test Device
The PSA Rapid Test Device (Whole Blood/Serum/Plasma) 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.
Principle of PSA Rapid Test Device
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.
