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The FREND™ Vitamin D test is a rapid indirect competitive fluorescent immunoassay designed for the quantitative measurement of 25-Hydroxy vitamin D and related hydroxylated metabolites in human serum and plasma (K;EDTA, lithium-heparin and citrate) specimens using the FREND™ System, and the FREND™ AP System. Measurements of total 25-hydroxy vitamin D and related hydroxylated metabolites are used to aid in the assessment of vitamin D sufficiency. The FREND™ Vitamin D microfluidic flow cartridge is designed for use in the FREND™ System fluorescent immunoassay reader, and the FREND™ AP System. The FREND™ Vitamin D Test System is intended for use in clinical laboratories. For in vitro diagnostic use only. The test is not intended for use in point-of-care settings.

The FREND™ Vitamin D Test is a rapid fluorescence immunoassay designed to quantify the concentration of total 25-hydroxy (OH) vitamin D and related hydroxylated metabolites in human serum and plasma (K3 EDTA, lithium-heparin and citrate) samples using the FREND™ System. The FREND™ Vitamin D Test System is a competitive immunoassay with gold microparticles labeled with Vitamin D-specific monoclonal anti-Vitamin D-antibody (mouse), Vitamin D-biotin labeled with fluorescence nanoparticles and fluorescence detection by the FREND™ System. The FREND™ Vitamin D Cartridge is a single-use disposable rapid lateral flow fluorescence immunoassay designed to quantify the concentration of total 25-OH vitamin D and related hydroxylated metabolites in human serum and plasma (K3 EDTA, lithiumheparin and citrate) samples. Each test cartridge contains reagents to perform one test and bears a bar code with test type and lot information. Each FREND™ Vitamin D Cartridge contains a test zone and a reference zone (internal control). The fluorescence measured in the test and reference zones corresponds to the amount of fluorescent conjugates of Vitamin D-biotin that is bound to each zone. Cartridges are provided in individually sealed pouches and must be stored between 2 and 8 °C. In addition to the QC Code Chip there is a Vitamin D Code Chip. Lot information and calibration data are loaded into the software via the Vitamin D Code Chip provided with each reagent kit. Up to three different Vitamin D Code Chip lots can be loaded and used at the same time. Each reagent cartridge bears a barcode that the FREND™ System uses to identify the test type and lot number and links it to the appropriate analytical program and calibration information. The FREND™ System will not output results if the Vitamin D Code Chip lot does not match the lot of the cartridge used. The Vitamin D Pretreatment Tube is a small single-use disposable plastic tube that contains Vitamin D gold nano-particle coniugation antibody. The sample is diluted in the dilution tube containing perfluorohexanoic acid and transferred to the pretreatment tube prior to being inserted into the FREND™ AP System to be mixed and then added to the Vitamin D Test Cartridge. The test cartridge is then inserted into the FREND™ System to be analyzed. The FREND™ AP System is an "Advanced Preparing" device that performs automated pre-analytical steps of mixing, timed heating, and pipetting of the sample from the Gold Antibody Pretreatment tube into the FREND Vitamin D test cartridge. The FREND™ System utilizes microfluidic technology and detects immune-complexes bound to Vitamin D. The test cartridge is placed on the warming platform of the FREND™ AP System. A 35 µL patient sample is added to the dilution tube and 70 µL of diluted sample is pipetted into the pretreatment tube containing monoclonal anti-Vitamin D antibody conjugated with gold nanoparticles(Step 1). The tube is then loaded into the FREND™ AP System (Step 2). The tube is mixed and loaded into the test cartridge automatically. In the AP System (Step 3), mixing, reaction, sample addition, hydration of the Vitamin D-biotin fluorescent bead conjugate, and migration along the cartridge channel takes approximately 15 minutes, after which the cartridge is read on the FREND™ System. During migration, the bound Vitamin D in the sample and the fluorescent bead conjugates of Vitamin D-biotin compete to form antigen-antibody complex in the test zone. Unbound Vitamin D-biotin fluorescent conjugates flow through and bind to the anti-Vitamin D antibody that is fixed on the surface in the reference zone. The fluorescent signals in the test and reference zones are measured, typically within 4 minutes. Vitamin D quantification is based upon the ratio of the intensity of the test and reference zones. A lower ratio of fluorescence is indicative of a higher Vitamin D concentration; in other words, the magnitude of the fluorescent ratio is inversely proportional to the amount of Vitamin D in the sample. The measuring range of the FREND™ Vitamin D Test System is 13.0 to 96.0 ng/mL. Results are determined via a lot-specific calibration curve which is generated by the manufacturer using a four-point calibration determined from values averaged from 6 replicates at each level. The established curve is uploaded to the FREND™ System via the Vitamin D Code-chip and is valid until the lot expiration date. The FREND™ System is a portable, automated FREND™ cartridge reader. The FREND™ System is based on quantitative immunoassay technology capable of quantifying single or multiple analytes by measuring laser-induced fluorescence in a single-use disposable reagent cartridge. The test cartridge is a disposable plastic device that contains a port or opening (inlet) where the sample is applied. Once the sample is applied, it will mix with the reagents and travel towards the detection area via capillary action. The FREND™ cartridge utilizes microfluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge. The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone. The FREND™ System is a bench top fluorescence reader containing a touch screen user interface. The System has a slot that accepts the FREND™ Vitamin D 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. The FREND™ System software controls the graphical user interface, communication with hardware, database management and data analysis. The software also controls the functions of the mechanical components including the motor, laser, printer control and acquisition of data from the sensor. The user can set the time and date and enter patient ID through the graphic user interface. The user cannot make any changes to the software. The FREND™ Vitamin D Test System includes the following in the reagent kit: - . 20 FREND™ Vitamin D Test Cartridges - 20 FREND™ Sample Dilution Tubes . - 20 FREND™ Vitamin D Gold Antibody Pretreatment Tubes . - 30 Disposable pipette tips - 1 FREND™ Vitamin D Code Chip . - . 1 FREND™ Vitamin D Package Insert One cartridge contains: - . Monoclonal mouse anti- Vitamin D 1.6 ± 0.16 na - . 25-hydroxyvitamin D 136 ± 13.6 ng - . Fluorescence particles 2.4 ± 0.24 µg One sample dilution tube contains: - . Perfluorohexanoic acid 9.5 ± 0.95 µg One Gold antibody pretreatment tube contains: - . Gold nano-particle conjugation antibody 7.0 ± 0.7 µg The FREND™ System (previously cleared in K124056 (FREND™ PSA), K131928 (FREND™ TSH), K152422 (FREND™ Free T4), and K153577 (FREND™ Testosterone) is not provided with the kit but it is required for the FREND™ Vitamin D Test cartridge.