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FREND™ TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND™ system. FREND™ TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.

The FREND™ System is a bench top fluorescence reader containing a simple computerized touchscreen user interface, easily manipulated to order tests, display results and operate the mechanical functions of the instrument. The specimen is added with a transfer pipette to the sample inlet of a single use cartridge by the operator, allowing the appropriate volume of sample (35 uL) to be delivered into the FREND™ TSH cartridge. The cartridge is then placed into the FREND™ system, which is programmed to begin analysis once the sample has reacted with the reagents. All reactions occur in the self-contained plastic cartridge and the reading is done in the cartridge as well. The FREND™ system has a slot that accepts the FREND™ TSH test cartridge containing the reagents and sample, and is programmed to analyze the test when the sample has fully reacted with the on-board in-cartridge reagents. Cartridges are loaded manually one by the operator. The reaction and analysis time is approximately 5 minutes. TSH quantitation is based on the ratio of fluorescence detected by the FREND™ System at the FREND™ TSH test and reference windows in the plastic cartridge compared to a standard curve stored in the TSH Code Chip that is included with each box of the device. A higher ratio of fluorescence is indicative of a higher TSH concentration. In other words, the magnitude of the fluorescent ratio is directly proportional to the amount of TSH in the sample.