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The Invader® Factor V test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.

The Invader Factor V test consists of the following components: Factor V Oligo Mix, Universal Buffer, Universal Enzyme Mix, No DNA Control, Factor V Wild Type Control, Factor V Heterozygous Control, Factor V Mutant Control, Invader Call Reporter™ Software, Invader® Factor V Software.

The VeraCode Genotyping Test for Factor V and Factor II is an in vitro diagnostic device for the detection and genotyping of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTA-anticoagulated human blood samples. The test is intended for use on the BeadXpress System. The VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

The VeraCode Genotyping Test for Factor V and Factor II assay consists of reagents sufficient for 96 tests, consisting of two boxes containing pre-PCR and post-PCR reagents. The pre-PCR box contains the following reagents: MTR1 (1 x 1.2 mL). AB1 (1 x 4 mL), AOP1 (1 x 4.8 mL), ELM (1 x 4.8 mL), FSB (1 x 4.8mL), UB3 buffer (2 x 4.8 mL) and AE1 reagent (2 x 4.8 mL). The post-PCR box contains MSS reagent (1 x 4.8 mL) and Fast Start Taq DNA Polymerase (1 x 60 µL), VW2 buffer (1 x 60 mL), a VeraCode FV/FII Bead Plate with holographically inscribed glass microbeads aliquoted in strip-well plates, a test-specific kit manifest file and sample sheet files (containing test specific outcome specifications and sample plate layout files used to interpret and report genotype results). A magnet plate is also required but sold separately.

The eSensor® Thrombophila Risk Test is an in vitro diagnostic for the detection and genotyping of Factor II (Prothrombin) G20210A, Factor V (Factor V Leiden) G1691A and MTHFR (human 5, 10 methylenetetrahydrofolate reductase gene) C677T and A1298C mutations with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System. The eSensor® FII-FV Genotyping Test is an in vitro diagnostic for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V (Factor V Leiden) G1691A mutations in patients with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System. The eSensor® FV Genotyping Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (FV; Coagulation Factor V gene) in patients with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System. The eSensor® FII Genotyping Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210 of the human Factor II gene (FII; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System. The eSensor® MTHFR Genotyping Test is an in vitro diagnostic for the detection and genotyping of point mutations (C to T at position 677) and (A to C at position 1298) of the human 5, 10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System.

The eSensor® Thrombophila Risk Tests on the eSensor® XT-8 System are in vitro diagnostic devices for performing hybridization and genotyping of multiple mutations and/or polymorphisms in an amplified DNA sample. A single-use, disposable test carridge is used to perform hybridization and genotyping. The cartridge contains an EEPROM chip which transmits the cartridge lot number, expiration date and protocol identity to the XT-8 instrument. The analysis process for each sample consists of three steps: 1) Genomic DNA isolated from whole blood obtained using EDTA as anti-coagulant is combined with PCR Mix and Taq polymerase enzyme and is subjected to amplification of target sequences by PCR using a thermal cycler. 2) Amplified DNA is treated with exonuclease enzyme to generate single-stranded target DNA. 3) Single-stranded, amplified target DNA is mixed with hybridization and genotyping reagents and transferred to an eSensor® Test cartidge, and the cartridge is inserted in the eSensor® XT-8 Instrument. The instrument controls the circulation of the cartridge to allow hybridization at a controlled temperature and then detects and genotypes the sample by voltammetry. Genotyping of the test panel polymorphisms is achieved by a sandwich assay principle: 1) Each pair of electrodes contains a different synthetic oligonucleotide capture probe which is complementary to one of the target DNA fragments. 2) The hybridization reagents contain pairs of ferrocene-labeled synthetic oligonucleotide signal probes; one member of each pair is complementary to the major allele sequence of the target polymorphism, while the second member of the pair is complementary to the minor allele sequence. Each member of the probe pair has a ferrocene label with a different oxidation potential for each allele. 3) Single-stranded, amplified target DNA hybridizes to its specific capture probe, and in turn hybridizes to the allele-specific, ferrocene-labeled signal probe. 4) Each electrode of the array is analyzed by voltammetry; the target polymorphism is determined by the location of the electrode containing the capture probe, and the genotype is identified by the ratio of signals from the allele-specific ferrocene labels. The array also includes positive controls to confirm the hybridization reaction and detect non-specific signals. Upon completion of the test, the EEPROM chip on the cartridge contains information that prevents its re-use with a new sample. The eSensor® XT-8 instrument analyzes the results and provides a report of the test results.

The Xpert™ HemosIL® Factor II & Factor V Assay is a qualitative in vitro diagnostic genotyping test for the rapid detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the Cepheid GeneXpert® Dx System. This test is intended to provide rapid results for Factor II (G20210A) and Factor V (Leiden) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

The Cepheid Xpert® HemosIL® Factor II & Factor V Assay is an automated DNA test for detecting Factor II and Factor V normal and mutant alleles directly from sodium citrate or EDTA anticoagulated whole blood specimens. Blood specimens are drawn into either sodium citrate or EDTA anticoagulant tubes. Following brief mixing of the sample, the blood sample and two single-use reagents (Reagent 1 and Reagent 2) that are provided with the assay are transferred to different, uniquely-labeled chambers of the disposable fluidic cartridge (the Xpert HemosIL Factor V cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert® Dx System instrument platform, which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of DNA. In this platform, sample preparation, amplification, and real-time detection are all fully-automated and completely integrated. The GeneXpert Dx System consists of a GeneXpert instrument, personal computer, a barcode scanner and the multi-chambered fluidic cartridges that are designed to complete sample preparation and real-time PCR for detection of Factor II and Factor V normal and mutant alleles in approximately 30 minutes. Each system has 1 to 16 randomly accessible modules that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids, an ultrasonic horn for lysing nuclei, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection. The Xpert HemosIL Factor II & Factor V Assay includes reagents for the detection of Factor II and Factor V normal and mutant alleles. The primers and probes in the Xpert HemosIL Factor II & Factor V Assay determine the genotype of the Factor II gene (at position 20210) and the Factor V gene (at position 1691). The test includes a Probe Check Control (PCC) that verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability and an instrument control verifies the instrument is performing properly. Additionally, the sample functions as its own internal control since both normal and mutant gene sequences are detected, and each person tested is expected to have one of these sequence signatures.

The INFINITI™ System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI™ System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI" System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

The INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management and software technology for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation from deoxyribonucleic acid (DNA) isolated from human whole peripheral blood samples. The INFINITI System Assay for Factor II & Factor V is comprised of the BioFilmChip" Microarray, the Intellipac™ Reagent Module, and the INFINITI Analyzer with the Qmatic" Operating Software. The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific. The Intellipac Reagent Module which acts as a communication link contains up to eight reservoirs that house the test reagents and has an integrated memory chip. The assay protocol resides in this memory chip and upon request is loaded to the INFINITI Analyzer. Information such as expiration date of reagents, volume usage, time of use and operation parameters are archived in the memory chip and appear on the worklist (run report). The INFINITI Analyzer is an instrument used for clinical multiplex systems intended to measure and sort multiple signals from a clinical sample. The INFINITI Analyzer is designed to measure fluorescence signals of labeled DNA target hybridized to BioFilmChip microarrays. The INFINITI Analyzer automates the Factor II and Factor V assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented in numerical and graphical format. The INFINITI Analyzer has two main components: pipetting and optics modules. A variety of electronic components inside the instrument are used for its operation. These include multiple stepper motors, heating and cooling devices, a barcode reader, a photomultiplier tube, and a camera all connected to USB ports. Pipetting Module - The pipetting module performs all the operations related to dispensing and aspiration of reagent and processing the amplified sample to be dispensed on the microarray. When the sample has been processed and hybridized to the microarray, it is transferred to the optics module for scanning and reading. Optics Module - The optics module is a lightproof assembly comprised of a 3-axis stage: camera, lasers, and a photo multiplier tube (PMT). It is the enclosed casement into which the microarray is transported automatically prior to being processed on the stringency station. The optics' stage follows X-Y-Z motions that can be stepped at a very precise rate (2.0 micron per step). Using excitation wavelengths of a 760nm laser diode, the camera takes a 1.2x1.2mm picture for each registration spot of a fluorescent die. Analyses of these pictures allow the location of three registration spots to be determined. With respect to the position of the three registration spots, coordinates of all the bio-spots can be located. While scanning, the stage moves along the Z-axis to focus the chip and the X and Y-axes to locate the individual spots on the microarray. The INFINITI Analyzer hardware is controlled by the Qmatic™ operating software, which is installed with-in the on-board computer and utilizes a LCD screen display. The INFINITI Analyzer modules are controlled by multitasking real time software. The Omatic "M operating software has a schedule manager that is capable of controlling all operations of the INFINITI Analyzer such as assay protocol, fluid handling, robotics, optical detection and result analysis. Results are available for review via the LCD screen. Management reports include results in numerical and graphical format. The operator can also print the displayed results in tabular form (printer not included with INFINITI Analyzer).