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The FREND™ PSA Plus as performed on the FREND™ system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FREND™ PSA Plus is designed for in vitro DIAGNOSTIC USE ONL Y for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FREND™ System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer. The FREND™ PSA Plus is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in managing patients with prostate cancer. The information provided from this test may supplement decision-making and should only be used in conjunction with routine monitoring by a physician and the use of other diagnostic procedures. Because of the variability in the effects of various medications used in the treatment of prostate cancer, clinicians should use professional judgment in the interpretation of PSA results as an indicator of disease status.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and EDTA plasma using the FREND™ system. The FREND™ PSA Plus is intended for use as an aid for prostate cancer management. The FREND™ PSA Plus Test is a single use fluorescence immunoassay designed to quantify the concentration of total PSA in serum and lithium heparin and EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (30 µL) to be delivered into the FREND™ PSA Plus Test Cartridge. The Cartridge is then placed into the FREND™ System, which is programmed to begin analysis once the sample has reacted with the reagents. The reaction and analysis time is approximately 6 minutes. The PSA quantification is based on the amount of fluorescence detected by the FREND™ System at the FREND™ PSA Plus Test Cartridge window. A higher level of fluorescence is indicative of a higher PSA concentration. In other words, the magnitude of the fluorescent signal is directly proportional to the amount of total PSA in the sample. The FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the FREND™ PSA Plus Test Cartridge (which contains the reagents and sample), and is programmed to analyze the Test when the sample has fully reacted with the on-board in cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer through the RS232C interface.