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The Xpert® FII & FV test is a qualitative in vitro diagnostic genotyping test for the detection of Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the GeneXpert® Instrument Systems. This test is intended to provide results for Factor II (G20210A) and Factor V Leiden (G1691A) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

Xpert FII & FV is an automated genotyping 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. 50 uL of the blood sample is transferred to the bottom wall of the Sample opening of the Xpert FII & FV test cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert Instrument System. The Xpert FII & FV test includes reagents for the detection of Factor II and Factor V normal and mutant alleles. The primers and probes in the Xpert FII & FV test determine the genotype of the Factor II gene (at position 20210) and/or the Factor V gene (at position 1691). The test includes a Sample Processing Control (SPC) to confirm adequate processing and to monitor the presence of inhibitor(s) in the PCR assay. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The GeneXpert Instrument Systems family is comprised of GeneXpert Dx System, GeneXpert Infinity System, and GeneXpert System with Touchscreen. The GeneXpert Instrument Systems automate and integrate sample processing, nucleic acid amplification and detection of the target sequences in simple or complex samples using real-time polymerase chain reaction (PCR). The systems consist of an instrument, computer or touchscreen, and preloaded software for running the tests and viewing the results. The GeneXpert Instrument Systems require the use of singleuse disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized. The GeneXpert Instrument Systems have 1 to 80 modules (depending upon the instrument) that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection. The Xpert FII & FV test performed on the GeneXpert Instrument Systems provides results in approximately 30 minutes.

The Xpert® FII & FV test is a qualitative in vitro diagnostic genotyping test for the detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the Cepheid GeneXpert® Instrument Systems. This test is intended to provide results for Factor II (G20210A) and Factor V Leiden (G1691A) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

The Cepheid Xpert® FII & FV is a rapid, automated DNA test for detecting FII and FV 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, 50 uL of the blood sample is transferred to the bottom wall of the Sample opening of the Xpert FII & FV test cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert® Instrument system instrument platform (comprised of the GeneXpert Dx Systems and GeneXpert Infinity Systems), which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of DNA. In the GeneXpert Instrument Systems platform, sample preparation, amplification, and real-time detection are all fully-automated and completely integrated. The GeneXpert Instrument Systems have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real- time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection. The Xpert FII & FV test includes reagents for the detection of Factor II and Factor V normal and mutant alleles. The primers and probes in the Xpert FII & FV test determine the genotype of the Factor II gene (at position 20210) and the Factor V gene (at position 1691). The test includes a Sample Processing Control to confirm adequate processing of the target bacteria and to monitor the presence of inhibitor(s) in the PCR assay. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The test is performed on the Cepheid GeneXpert Instrument Systems, which automate and integrate sample purification, nucleic acid amplification of the target sequences in simple or complex samples using real-time PCR. The systems consist of an instrument, personal computer, and preloaded software for running the tests and viewing the results. The GeneXpert Instrument Systems require the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, crosscontamination between samples is minimized. In this platform, additional sample preparation, amplification, and real-time detection are all fully- automated and completely integrated. The Xpert FII & FV test performed on the GeneXpert Instrument Systems provides results in approximately 30 minutes.

The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and the cobas z 480 analyzer are used together for automated amplification and detection.

The cobas® Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The userselected DNA extraction method must provide DNA of sufficient concentration. Automated realtime PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. Depending upon the test order, results for one or both mutations are reported for each DNA sample. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of a real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas® 4800 System CU). The amplification reactions generate a Factor II specific amplicon and a Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative in vitro diagnostic device intended for use in the detection and genotyping of a single point mutation (G1691A, referred to as the Factor V Leiden mutation or FVL) of the Factor V gene, located on Chromosome 1q23, and a single point mutation (G20210A) of the prothrombin gene (referred to as Factor II or FII), located on Chromosome 11p11-q12, from genomic DNA isolated from EDTA anti- coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative, multiplexed genetic testing device for parallel detection and genotyping of the point mutations G1691A of the Factor V gene and G20210A of the Factor II gene from genomic DNA isolated from EDTA anti- coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed using the IMPACT Dx System, which includes the IMPACT Dx NANO and the IMPACT Dx MA, a matrix-assisted laser desorption / ionization time-of-flight (MALDI-TOF) mass spectrometer. The test involves Factor V and Factor II region-specific polymerase chain reaction (PCR) amplification of genomic DNA purified from human whole blood in a multiplexed reaction, followed by allele-specific single base primer extension reactions. The reaction products are desalted, dispensed onto a SpectroCHIP® Array using the IMPACT Dx NANO, and the genotyping products are resolved on the basis of mass using the IMPACT Dx MA. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test provides reagents for multiplex PCR, deoxynucleotide triphosphate dephosphorylation, and single base extension. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is comprised of the following components: - IMPACT Dx Factor V Leiden and Factor II Primer Set - IMPACT Dx PCR Reagent Set - IMPACT Dx Extend Reagent Set The IMPACT Dx Factor V Leiden and Factor II Genotyping Test utilizes a biochemistry process (Sequenom Biochemistry) that involves target-specific PCR amplification and single-base extension reactions with the subsequent analysis of the reaction products of the target nucleic acids by matrixassisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), The IMPACT Dx System (System) is a platform for highly accurate and sensitive genomic analysis and is designed for use with FDA cleared or approved assays citing its use. The IMPACT Dx System is comprised of the following instruments, software and consumables; - IMPACT Dx NANO (NANO) - IMPACT Dx MA (MA) - TYPER Dx Software (TYPER Dx) - System Consumables - SpectroCHIP® Arrays (Chip) - Clean Resin - 3-Point Calibrant (Calibrant) The System is intended to be used by trained operators in a professional laboratory to perform the following key tasks: - De-salt (using Clean Resin) amplified nucleic acid samples, upon completion of polymerase chain reaction (PCR) and single-base extension reactions following the instructions provided in the Sequenom test-specific package insert; - Transfer (using the IMPACT Dx NANO) de-salted nucleic acid samples from a microtiter plate onto a disposable 96-pad sample Chip; - Obtain mass spectra (using the IMPACT Dx MA) from samples and 3-Point Calibrant on a Chip; and - Analyze (using the TYPER Dx software) the mass spectra of the samples for genotyping results. The IMPACT Dx System accomplishes genomic analysis and genotyping testing by coupling a biochemistry process (Sequenom biochemistry) that involves target-specific PCR amplification and single-base extension reactions with the subsequent analysis of the reaction products of the target nucleic acids by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). This biochemistry process is homogeneous and does not require purification of the PCR products or the extension products and thus is very amenable to high-throughput genotyping testing. The IMPACT Dx NANO is a self-contained, enclosed instrument that uses computer-controlled robotics to transfer nanoliter volumes of analyte from a 96-well microtiter plate onto a Chip, which is subsequently processed by means of MALDI-TOF MS analysis on the IMPACT Dx MA. This instrument includes an integrated computer pre-loaded with the Nanodispenser software and provides a simple touch-screen interface for users. The IMPACT Dx MA is a bench top mass spectrometer that processes analyte-loaded Chips by means of MALDI-TOF MS analysis. This instrument includes an integrated computer pre-loaded with the TYPER Dx software, a monitor, and a firewall for secure communication with the IMPACT Dx NANO. The main function of the IMPACT Dx MA is to acquire mass spectra from analytes that have been transferred onto a Chip, which has a chemical matrix on each pad. The mass spectra are captured and further analyzed by the TYPER Dx software. The TYPER Dx software (TYPER Dx) manages the processing of Sequenom genotyping tests. It is deployed on the computer embedded within the IMPACT Dx MA. The TYPER Dx software provides the following key functions: - Allows users to create and manage panel runs; - Monitors analyte transfer activities on the IMPACT Dx NANO; - Controls user-initiated, automated mass spectrum acquisition runs on the IMPACT Dx MA; - Analyzes the mass spectra acquired by the IMPACT Dx MA and makes genotype calls per a test-specific algorithm; - Enables users to view and export results; and - Allows an administrator to manage users to ensure secure access to the IMPACT Dx MA and panel run data.

The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic test for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA of human saliva samples collected using the Oragene® Dx Device, as an aid in the identification of patients at risk for increased warfarin sensitivity.

The eSensor® Warfarin Sensitivity Saliva Test is a multiplex microarray-based genotyping test system. It is based on the principles of competitive DNA hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to sequence-specific solution-phase signal probe and solid-phase electrode-bound capture probe. The test employs polymerase chain reaction amplification, exonuclease digestion and hybridization of target DNA. In the process, the double stranded PCR amplicons are digested with exonuclease to generate single stranded DNA suitable for hybridization. Hybridization occurs in the eSensor XT-8 Cartridge (described below) where the singlestranded target DNA is mixed with a hybridization solution containing labeled signal probes. During hybridization, the target DNA binds to a complementary, single-stranded capture probe immobilized on the working electrode surface. Single-stranded signal probes (labeled with electrochemically active ferrocenes) bind to the target adjacent to the capture probe. When inserted into the eSensor XT-8 instrument (described below), simultaneous hybridization of target to signal probes and capture probe is detected by alternating current voltammetry (ACV). Each pair of working electrodes on the array contains a different capture probe, and sequential analysis of each electrode allows genotyping of multiple mutations or polymorphisms. The Assay Cartridge (eSensor XT-8 Cartridge): The eSensor XT-8 cartridge device consists of a printed circuit board (PCB) with a multi-layer laminate and a plastic cover that forms a hybridization chamber has a volume of approximately 140 µl. The cartridge consists of a diaphragm pump and check valves (microfluidic components) that circulate the hybridization solution in the hybridization chamber when inserted into the eSensor XT-8 instrument. The PCB chip consists of an array of 72 gold-plated working electrodes, a silver/silver chloride reference electrode, and two gold-plated auxiliary electrodes. Each working electrode has a connector contact pad on the opposite side of the chip for electrical connection to the eSensor XT-8 instrument. Each electrode is modified with a multicomponent, self-assembled monolayer that includes presvnthesized oligonucleotide capture probes specific for each polymorphic site on the test panel and insulator molecules. The cartridge also contains an electrically erasable programmable read-only memory component (EEPROM) that stores information related to the cartridge (e.g., assay identifier, cartridge lot number, and expiration date). The eSensor XT-8 Instrument (Same as cleared under k073720): The eSensor XT-8 is a clinical multiplex instrument that has a modular design consisting of a base module and one, two, or three cartridge-processing towers containing 8, 16, or 24 cartridge slots, respectively. The cartridge slots operate independently of each other. Any number of cartridges can be loaded at one time, and the remaining slots are available for use while the instrument is running. The base module controls each processing tower, provides power, and stores and analyzes data. The base module includes the user interface, and a 15-in. portrait-orientation display and touch panel. The instrument is designed to be operated solely with the touch screen interface. Entering patient accession numbers and reagent lot codes can be performed by the bar code scanner, the touch screen, or uploading a text file from a USB memory stick. Each processing tower consists of eight cartridge modules, each containing a cartridge connector, a precision-controlled heater, an air pump, and electronics. The air pumps drive the diaphragm pump and valve system in the cartridge, eliminating fluid contact between the instrument and the cartridge. The pneumatic pumping enables recirculation of the hybridization solution allowing the target DNA and the signal probes to hybridize with the complementary capture probes on the electrodes. The diaphragm pump in the cartridge is connected to a pneumatic source from the eSensor XT-8 instrument and provides unidirectional pumping of the hybridization mixture through the microfluidic channel during hybridization. Using microfluidic technology to circulate the hybridization solution minimizes the unstirred boundary layer at the electrode surface and continuously replenishes the volume above the electrode that has been depleted of complementary targets and signal probes. The XT-8 instrument provides electrochemical detection of bound signal probes by ACV and subsequent data analysis and test report generating functions. All hybridization, ACV scanning and analysis parameters are defined by a scanning protocol loaded into the XT-8 Software, and then specified for use by the EEPROM on each cartridge. The Assay Kit: The Warfarin Sensitivity Saliva Test consists of the test cartridge and the following components: 1) PCR REAGENTS consisting of: PCR Mix [PCR buffer containing primers and dNTP mixture (dCTP, dGTP, dATP, and dUTP)], MgCl2 thermostable DNA polymerase (Taq Polymerase ); and 2 GENOTYPING REAGENTS consisting of: lambda exonuclease, signal probes and hybridization buffer ingredients (Buffer-1 and Buffer-2).

The Invader® Factor II test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.

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

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 Invader® MTHFR 677 test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5.10-methylenetetrahydrofolate reductase (MTHFR) gene in isolated genomic DNA obtained from whole blood Potassium EDTA samples from patients with suspected thrombophilia.

The Invader MTHFR 677 test consists of the following components: MTHFR 677 Oligo Mix Universal Buffer Universal Enzyme Mix No DNA Control MTHFR 677 Wild Type Control MTHFR 677 Heterozygous Control MTHFR 677 Mutant Control Invader Call Reporter™ Software

The Invader® MTHFR 1298 test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (A to C at position 1298) of the human 5,10-methylenetetrahydrofolate reductase (MTHFR) gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.

The Invader MTHFR 1298 test consists of the following components: MTHFR 1298 Oligo Mix Universal Buffer Universal Enzyme Mix No DNA Control MTHFR 1298 Wild Type Control MTHFR 1298 Heterozygous Control MTHFR 1298 Mutant Control Invader Call Reporter™ Software Invader® MTHFR 1298 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.