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The Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel is a multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) in vitro diagnostic test for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza B virus, and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza B, and RSV A/B (undifferentiated) infections in humans and is not intended to detect influenza C virus infections. Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infective of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organism(s) detected by the Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. The Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel is a multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) test. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, respiratory syncytial virus (RSV) A/B and RNase P primer and probe sets are designed to detect viral RNA in nasopharyngeal (NP) and anterior nasal (AN) swab specimens from individuals exhibiting signs and symptoms of a respiratory tract infection. Each TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel includes the following components: - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay-Multiplex assays that contain . primer and probe sets specific to the following targets: - Three SARS-CoV-2 targets (Orfla, Orf1b, and N genes) . - . Two influenza A virus targets (PB1 & M genes) - I Two influenza B virus targets (M & NS genes) - . Three RSV targets (NP, M, and L protein genes) - l RNase P (internal human sample collection control) - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control—Inactivated viral . control that contains SARS-CoV-2, influenza A, influenza B, and RSV. - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control—MS2 packaged RNA . control that contains targets specific to RNase P genomic regions targeted by the assay. - TaqPath™ 1-Step Select Master Mix (No ROX)—Ready-to-use PCR mix, including . reverse transcriptase, polymerase, dNTPs, salts, and buffer. - . Package Insert -- Provides the instructions and the link to download the instructions for use and other assets (including the ADF) - An Assay Definition File (ADF) applicable to the instrument used in the workflow . (available via download). In addition to the SARS-CoV-2, influenza A, influenza B and RSV viral assay targets, the assay portion of the panel includes RNase P, which serves as an endogenous internal process control to monitor extraction and amplification of each clinical sample. The TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel also contains external process positive and negative controls. The positive control (PC) component included is an inactivated viral control that contains SARS-CoV-2, influenza A, influenza B, and RSV viruses. The PC monitors extraction and real-time RT-PCR by demonstrating that each of the four viruses can be detected when present and that RNase P is not detected when absent. The negative control (NC) component included is an MS2 packaged RNA control that contains targets specific to RNase P genomic regions targeted by the assay. The NC also monitors extraction and real-time RT-PCR by demonstrating RNase P can be detected when present and that the four viruses are not detected when absent. The TaqPath™ 1-Step Select Master Mix (No ROX) included as a component of the kit is a ready-to-use PCR mix which contains a deoxyribonucleotide triphosphate mix (dNTPs), enzymes, and other components to permit reverse transcription and amplification of the assay targets. The TagPath™ 1-Step Select Master Mix (No ROX) also contains ribonuclease (RNase) inhibitors as well as deoxyuridine triphosphate (dUTP) and uracil N-glycosylase (known as UNG or UDG). The TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel is provided in two overall kit configurations: either 200 reactions or 1.000 reactions.

The TaqPath™ COVID-19 Diagnostic PCR Kit is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and anterior nasal specimens from individuals with signs and symptoms of respiratory tract infection. The TaqPath™ COVID-19 Diagnostic PCR Kit is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical observations, epidemiological information and laboratory findings. The SARS-CoV-2 RNA is generally detectable in upper respiratory (anterior nasal and nasopharyngeal swabs) specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other pathogens. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The TaqPath™ COVID-19 Diagnostic PCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The Applied BioSystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (TaqPath™ COVID-19 Diagnostic PCR Kit) includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal and anterior nasal specimens from individuals with signs and symptoms of respiratory tract infection. Each kit includes the following components: - Multiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for bacteriophage MS2 - MS2 Phage Control as an internal process control for nucleic acid extraction - TaqPath™ COVID-19 Diagnostic PCR Control as a positive RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays. The workflow begins with nucleic acid extraction from upper respiratory specimens (nasopharyngeal and anterior nasal swabs) that arrive in the testing site in transport media. Nucleic acids are isolated and purified from the specimens using the MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit. Nucleic acid isolation is performed via an automated process using the KingFisher™ Flex Purification System. The nucleic acid is reverse transcribed into cDNA and amplified using the TaqPath™ COVID-19 Diagnostic PCR Kit and one of the following real-time PCR instruments: - Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument - Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR Instrument In the process, the probes anneal to three (3) specific SARS-CoV-2 target sequences located between three (3) unique forward and reverse primers for the following genes: - ORF1ab - N gene - S gene During the extension phase of the PCR cycle, the 5' nuclease activity of Taq polymerase degrades the probe, causing the reporter dye to separate from the quencher dye, generating a fluorescent signal. With each PCR cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescent intensity, which is measured at each cycle by the real-time PCR instrument. Following RT-PCR, the data from the instrument's data collection software are imported into COVID-19 Interpretive Software IVD Edition for analysis and interpretation. After data import, the software analyzes the run data, performs quality check (QC) analysis, and calculates the interpretive results for each sample and control. The imported data and interpretive results for each run are saved as a batch in the software. Results can be exported as CSV files and reports can be generated in PDF format. Validation of the results is performed automatically by the COVID-19 Interpretive Software based on performance of the positive and negative controls. The following results are automatically generated using the calling rules, plate validity and the CT cutoff values for assay targets: | ORF1ab | N gene | S gene | MS2 | Status | Result | Action | |--------|-----------------------------------------|--------|---------------|--------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | NEG | NEG | NEG | NEG | INVALID | NA | RETEST<br>Repeat test by re-extracting the<br>original sample and repeating the RT-PCR. If the<br>repeat result remains invalid, consider<br>collecting a new specimen. | | NEG | NEG | NEG | POS | VALID | SARS-CoV-2<br>Not Detected | REPORT<br>Report the results to the healthcare<br>provider. | | | Only one SARS-CoV-2 target<br>= POS | | POS or<br>NEG | VALID | SARS-CoV-2<br>Inconclusive | RETEST/REPORT<br>1. Repeat the test by re-extracting the<br>original sample and repeating the<br>RT-PCR.<br>IMPORTANT! Samples with a<br>result of SARS-CoV-2 Inconclusive<br>shall be retested one time.<br>2. After retesting one time, report the<br>results to the healthcare provider.<br>3. If the repeat result remains<br>inconclusive, the healthcare<br>provider should conduct additional<br>confirmation testing with a new<br>specimen, if clinically indicated. | | | Two or more SARS-CoV-2 targets<br>= POS | | POS or<br>NEG | VALID | Positive SARS-<br>CoV-2 | REPORT<br>Report the results to the healthcare<br>provider. | A minimum of one negative control and one positive control must be present for each run. Additional negative control wells shall be run for each extraction that is represented on a realtime RT-PCR plate. All control wells must pass for the real-time RT-PCR plate to be considered valid. Recommended actions of retest or report are also provided depending on the results generated.

The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis. The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.

The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are fluorescence-based DNA analysis instruments that use capillary electrophoresis technology with 8 and 24 capillaries, respectively. The 8-capillary system and the 24-capillary system include the following components: - 8-capillary or 24-capillary array and POP™ polymer . - . Consumables for system qualification - Computer workstation and monitor - Integrated software for instrument control, data collection, quality control, . basecalling and sizecalling of samples The following consumables (branded with the Applied Biosystems name) are required to operate the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer. - . 50cm Capillary Array: enable the labeled DNA fragments to migrate from the cathode toward the anode for detection - POP-6TM Polymer: used as a separation matrix to separate DNA fragments by size ● during electrophoresis for sequencing - POP-7TM Polymer: used as a separation matrix for separating DNA fragments by size during electrophoresis for fragment analysis - Hi-Di™ Formamide: sample re-suspension solution used for electrokinetic ● injection and denaturing the DNA - Sequencing Standard v1.1: used for spectral calibration of the instrument and instrument performance check - Cathode Buffer Container: pre-filled with running buffer which maintains a source . of ions and the correct pH for electrophoresis - Anode Buffer Container: pre-filled with running buffer which maintains a source ● of ions and the correct pH for electrophoresis - Conditioning Reagent: pre-filled pouch used for priming the polymer pump, ● washing the pump between polymer type changes, and during instrument shutdown - DS-30 Matrix Standard Dx: used for spectral calibration ● - DS-33 Matrix Standard - Dx: used for spectral calibration - DS-33 GeneScan™ Install Kit Dx: used for instrument operational qualification ● - GeneScan™ 600 LIZ® Size Standard v2.0 Dx: used as a ladder for sizing DNA ● fragments - Other accessories (e.g. sample plate holders, plate retainers, septa) .

The lon PGM™ Dx Instrument System is intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The lon PGM™ Dx Instrument System is not intended for whole genome or de novo sequencing.

The Ion PGM™ Dx System is used for detection of human variant sequences from DNA from whole blood samples or RNA and DNA from FFPE tissue samples. Detectable variants include substitutions, insertions, and deletions. The Ion PGMTM Dx System consists of the following: - Ion OneTouch™ Dx Instrument - Ion OneTouch™ ES Dx Instrument - Ion OneTouch™ Rack Kit - Ion PGM™ Dx Chip Minifuge - Ion PGM™ Dx Sequencer - Ion PGMTM Wireless Scanner - DynaMag™ Dx Kit—Tube & Plate - Ion Torrent™ Server - Torrent Suite™ Dx Software The Ion PGM™ Dx System is used in conjunction with the following kits: - Ion PGM™ Dx Library Kit - Ion OneTouch™ Dx Template Kit - Ion PGM™ Dx Sequencing Kit - Ion 318™ Dx Chip Kit The system should be used only by professionals trained in laboratory techniques and procedures and in the use of the system.

The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended to perform fluorescence-based PCR to provide detection of FDA cleared and approved nucleic acid sequences in human-derived specimens. The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument.

The QuantStudio™ Dx Real-Time PCR Instrument is a bench top Real-Time PCR instrument that uses fluorescent-based polymerase chain reaction (PCR) reagents to provide qualitative or quantitative detection of target nucleic acid sequences (targets) using real-time analysis. The QuantStudio™ Dx Real-Time PCR Instrument system includes the following components: - QuantStudio™ Dx Real-Time PCR instrument with embedded graphical user . interface (eGUI) Touchscreen - Thermal Block, also referred to as the sample block, with associated Heated Cover . and Plate Adaptor - Calibration and verification materials for instrument qualification . - . Computer workstation with a monitor, keyboard and mouse - QuantStudio™ Dx instrument software .

StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

StemPro® MSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). StemPro® MSC SFM enables human MSC growth and increased consistency compared to classical serum-supplemented medium. In addition, human MSCs can be expanded for multiple passages while maintaining their multipotential phenotype (i.e. ability to differentiate into osteogenic, chondrogenic, adipogenic lineages). StemPro® MSC SFM contains two components: StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement.

Knockout™ SR Medium and Knockout™ SR Xenofree Medium are liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

Knockout™ SR is a serum-free medium with a defined formulation that provides consistent growth conditions for human and mouse embryonic stem cell (ESC) and patient-specific induced pluripotent cell lines (iPSCs). Knockout™ SR Xenofree is a serum-free and animal origin-free defined formulation that provides consistent growth conditions for human and mouse embryonic stem cell (ESC) and patient-specific induced pluripotent cell lines (iPSCs). All animal derived components have been replaced with human derived or synthetic components to yield a xenogeneic-free formulation.