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The LIAISON PLEX® Gram-Positive Blood Culture Assay (BCP), performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-positive pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. BCP is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria as determined by Gram stain. The BCP Assay detects and identifies the following: Gram Positive Resistance Markers: - mecA/mecC - vanA - vanB Genera and Species: - Bacillus spp. - Enterococcus faecalis - Enterococcus faecium - Listeria spp. - Staphylococcus spp. - Staphylococcus aureus - Staphylococcus epidermidis - Staphylococcus lugdunensis - Streptococcus spp. - Streptococcus agalactiae - Streptococcus anginosus group - Streptococcus pneumoniae - Streptococcus pyogenes Negative results for antimicrobial resistance genes do not indicate bacterial susceptibility as there are multiple mechanisms that can contribute to resistance. The LIAISON PLEX® BCP Assay contains targets for the detection of genetic determinants associated with resistance to methicillin (mecA/C) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In mixed growth, the LIAISON PLEX BCP Assay does not specifically attribute vanA/vanB-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA/mecC-mediated methicillin resistance to either Staphylococcus spp., S. aureus, S. epidermidis or S. lugdunensis. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of methicillin and vancomycin resistance exist. The LIAISON PLEX® BCP Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections (BSI). The LIAISON PLEX® BCP Assay is not intended to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by the LIAISON PLEX BCP Assay, to detect mixed infections that may not be detected by the LIAISON PLEX BCP Assay, for association of antimicrobial resistance genes to a specific organism, or for epidemiological typing.

The LIAISON PLEX® Gram-Positive Blood Culture Assay (BCP Assay) is an automated test for the detection and identification of nucleic acid from gram-positive bacteria in a positive blood culture media sample. The BCP Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system, and which contain gram-positive bacteria, as determined by a Gram stain. The LIAISON PLEX® System is a fully automated, bench-top "sample-to-answer" device that performs sample preparation and microarray-based hybridization for the detection of target-specific nucleic acids. The test reagents are supplied as a single, disposable test cartridge. Target amplification is not performed as part of the BCP Assay workflow, as it is a non-amplified, direct detection test performed on the LIAISON PLEX® System.

The LIAISON PLEX® Gram‐Negative Blood Culture (BCN) Assay, performed using the automated, sample‐to‐result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram‐negative pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. LIAISON PLEX® BCN Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system which contain gram‐negative bacteria as determined by Gram stain. The LIAISON PLEX® BCN Assay detects and identifies the following: Resistance Markers: - CTX‐M (blaCTX‐M) - IMP (blaIMP) - KPC (blaKPC) - NDM (blaNDM) - OXA (blaOXA) - VIM (blaVIM) - MCR - SME (blaSME) Gram Negative Genera and Species: - Enterobacteriaceae / Morganellaceae - Acinetobacter baumannii - Acinetobacter spp. - Citrobacter spp. - Enterobacter spp. (1) - Escherichia coli (2) - Haemophilus influenzae - Klebsiella oxytoca - Klebsiella pneumoniae - Klebsiella variicola - Morganella morganii - Neisseria meningitidis - Proteus spp. - Pseudomonas aeruginosa - Pseudomonas spp. - Salmonella spp. - Serratia marcescens - Stenotrophomonas maltophilia (1) Due to reclassification, Klebsiella aerogenes will be reported Enterobacter spp. (2) LIAISON PLEX® BCN Assay will not distinguish between Escherichia coli and Shigella spp. (S. dysenteriae, S. boydii, S. flexneri and S. sonnei) LIAISON PLEX® BCN Assay contains targets for the detection of genetic determinants associated with resistance to carbapenems (blaCTX‐M, blaIMP, blaKPC, blaNDM, blaOXA48‐like, blaVIM, blaSME) to aid in the identification of potentially antimicrobial‐resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant MCR, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to ß‐lactams and colistin exist. LIAISON PLEX® BCN Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections (BSI). LIAISON PLEX® BCN Assay is not intended to monitor treatment of these infections. Sub‐culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by LIAISON PLEX® BCN Assay, to detect mixed infections that may not be detected by LIAISON PLEX® BCN Assay, for association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

The LIAISON PLEX® Gram‐Negative Blood Culture (BCN) Assay is an automated test for the detection and identification of nucleic acid from gram‐negative bacteria in a positive blood culture media sample. The BCN Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system, and which contain gram‐negative bacteria, as determined by a Gram stain. The LIAISON PLEX® System is a fully automated, bench‐top "sample‐to‐answer" device that performs sample preparation, polymerase chain reaction (PCR) and microarray‐based hybridization for the detection of target‐specific nucleic acids. The test reagents are supplied as a single, disposable test cartridge. PCR is not performed on the LIAISON PLEX® BCN Assay, as it is a non‐amplified, direct detection test performed on the LIAISON PLEX® System.

The LIAISON PLEX Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The LIAISON PLEX BCY Assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The LIAISON PLEX BCY Assay detects and identifies the following fungal organisms: Candida albicans Candida auris Candida dubliniensis Candida famata Candida glabrata Candida guilliermondii Candida kefyr Candida krusei Candida lipolytica Candida lusitaniae Candida parapsilosis Candida tropicalis Candida haemulonii / duobushaemulonii Cryptococcus neoformans / gattii The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from LIAISON PLEX BCY Assay are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment management decisions. Negative results in the setting of a suspected bloodstream infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by LIAISON PLEX BCY Assay may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by LIAISON PLEX BCY Assay, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.

The LIAISON PLEX "Yeast Blood Culture Assay (BCY Assay) is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system, and which contain a fungal organism, as determined by a Gram stain. The system consists of an instrument, a single-use disposable test cartridge, and a transfer pipette. The user loads the sample into the sample port of the LIAISON PLEX Yeast Blood Culture Assay Cartridge. Next, the user sets up the sample order on the LIAISON PLEX System by first entering the sample information or scanning the barcode ID located on the sample tube, then scanning the barcode ID located on the test cartridge. Last, the user inserts the test cartridge into the processing module to initiate the test. The LIAISON PLEX System identifies the assay being run and automatically initiates the proper testing protocol to process the sample, analyze the data, and generate test results. The LIAISON PLEX System automates the BCY Assay sample analysis through the following steps: a) Sample Preparation: Nucleic acid extraction via mechanical and chemical cell lysis and magnetic bead-based nucleic acid isolation; b) Amplification: Multiplex PCR based amplification of the extracted nucleic acid to generate target specific amplicons; c) Hybridization: Amplified DNA hybridizes to specific capture DNA arrayed on a glass slide in a microarray format and the bound target DNA, in turn, hybridizes with mediator and gold-nanoparticle probes; d) Signal Analysis: Gold nanoparticle probes bound specifically to target-containing spots in the microarray are silver-enhanced, and light scatter from the spots is measured and further analyzed to determine the presence (Detected) or absence (Not Detected) of a target.

The LIAISON PLEX Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection and identification of multiple bacterial and viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2. The test is performed on the automated LIAISON PLEX System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific nucleic acid gene sequences of the following organism types and subtypes: Viruses: Adenovirus Human Coronavirus (HKU1, NL63, OC43, and 229E not differentiated) Human Enterovirus/Rhinovirus (not differentiated) Human Metapneumovirus, Influenza A Influenza A (subtype H1) Influenza A (subtype H3) Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Bacteria: Bordetella holmesii Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae Nucleic acids from the bacterial and viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific bacterial and viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by this test or due to lower respiratory that is not detected by an NPS specimen. Conversely, positive results do not rule out infection or co-infection with organisms not detected by the LIAISON PLEX Respiratory Flex (RSP Flex) Assay. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography), may be necessary when evaluating a patient with possible respiratory tract infection.

The LIAISON PLEX® Respiratory Flex Assay is a multiplexed nucleic acid test system composed of the LIAISON PLEX Instrument, the LIAISON PLEX® System Software (preinstalled on the LIAISON PLEX Instrument), the LIAISON PLEX® Respiratory Flex Assay cartridge, and the LIAISON PLEX® Respiratory Flex Assay File. The LIAISON PLEX® Respiratory Flex Assay cartridge contains the reagents to perform nucleic acid extraction and purification, reverse transcription, PCR, and array hybridization. Specifically, the LIAISON PLEX® Respiratory Flex Assay detects bacteria and viruses from nasopharyngeal swab (NPS) specimens collected from individuals with signs and symptoms of respiratory infection. The LIAISON PLEX System consists of a touchscreen user interface that includes the software for running and analyzing assay results, one to six processing/imaging LIAISON PLEX modules, and a handheld barcode reader. Each LIAISON PLEX module processes one sample at a time under the control of the LIAISON PLEX System software. LIAISON PLEX® automates the sample processing through analysis within a single cartridge. Processing steps include 1.) Sample Preparation: Nucleic acid extraction from organisms by chemical and mechanical means and isolation of nucleic acid on magnetic beads 2.) Target Amplification: Multiplex PCR and RT-PCR based amplification of extracted nucleic acid to generate target specific amplicons 3.) Hybridization: Amplicons hybridize with their target specific DNA probe arranged in a microarray format and that are attached to mediator and gold nanoparticles 4.) Analysis: Gold nanoparticles specifically bound to target amplicons are silver enhanced and the light scatter from microarray spot is measured and analyzed to confirm presence (Detected) or absence (not Detected) of a target. The LIAISON PLEX Respiratory Flex Assay has the option of creating and processing results for custom panels using Flex® Software. Flex Software allows users to randomly select and group targets in tiers for result processing. Up to 7 targets may be selected for the initial test tier. After the first tier, each additional tier requires a specific number of credits. Flex™ credits allow the end-user to create custom panels and pay for a smaller subset of results tailored to the individual patient's clinical presentation. Alternatively, a laboratory may choose the fixed price option where all target results are processed at the same time.

The ARIES® MRSA Assay is an integrated, real-time, polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of methicillinresistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The ARIES® MRSA Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. The ARIES® MRSA Assay is indicated for use with ARIES® Systems.

The ARIES® MRSA Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system which consists of the ARIES® System or the ARIES® M1 System with their included ARIES® Software, a sample processing tube, an assay-specific cassette, and an assay-specific protocol file. The ARIES® MRSA Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® MRSA Assay cassette directly detects methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk of nasal colonization. Specifically, the ARIES® MRSA Assay cassette detects the methicillin resistance genes (mecA and mecC), Staphylococcus aureus orfX gene, the SCCmec junction region, and a DNA Sample Processing Control. Nasal swab specimens are collected using the Liquid Amies Elution Swab (ESwab™) Collection and Transport System, or equivalent. A portion of the sample is transferred to the provided 2 mL ARIES MRSA Sample Processing Tube and vortexed. The processed sample is then transferred to the ARIES® MRSA Assay cassette. The specimen is lysed and nucleic acid is extracted using an ARIES® instrument. An extractable sample processing control (SPC) target present in the ARIES® MRSA Assay cassette is processed with the specimen. The SPC controls for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® MRSA Assay lyophilized PCR reagents in the PCR tube that contain primer pairs and probes specific to mecA/mecC, orfX, SCCmec and the SPC sequence. Each probe is labeled with a distinct fluorophore and detected in a distinct channel of an ARIES® System. PCR amplification is performed and assay fluorescence is monitored. Hybridization of a fluorescently labeled probe to the amplified target results in the release of quenching and generation of fluorescence signal that is indicative of PCR generated amplicon. Following amplification, the reaction is heated to separate the fluorescentlabeled probe from the amplified target, a process that results in a decrease in the fluorescence signal. The reaction fluorescence is measured during this process and the temperature at which the change in fluorescence is the maximum is the Tm of the amplicon. The instrument fluorescence output is analyzed and test results are determined using the ARIES® System software and the ARIES® MRSA Assay protocol and run files. ARIES® MRSA Assay results may be reported from the ARIES® Software or from the optional SYNCT® Software.

The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. The ARIES® Group A Strep Assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. The ARIES® Group A Strep Assay is indicated for use with ARIES® Systems.

The ARIES® Group A Strep Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES® System or the ARIES® M1 System with their included ARIES® Software, an assay-specific cassette, and an assay-specific protocol file. The ARIES® Group A Strep Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® Group A Strep Assay cassette directly detects Streptococcus pyoqenes (Group A ß-hemolytic Streptococcus) in throat swab specimens collected from the surface of human tonsils and posterior pharyngeal wall. Throat swab specimens are collected from patients using a commercially available Liquid Amies based transport system (Nylon Flocked Swab with 1 mL modified Liquid Amies (ESwab™). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using an ARIES® System. An extractable sample processing control (SPC) target is present in the ARIES® Group A Strep Assay cassette and is processed with the specimen. The SPC controls for recovery of extracted nucleic acid, the presence of inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® Group A Strep Assay lyophilized PCR reagents in the PCR tube that contains primer pairs specific to the S. pyogenes DNaseB (sdaB) gene and the SPC sequence. Each of the primer pairs is labeled with a distinct fluorophore and detected in distinct channels of the ARIES® Systems. PCR amplification is performed and assay fluorescence is monitored. Incorporation of a quencher-labeled nucleotide results in a decrease in fluorescence for the associated primer pair. Following amplification, the reaction is slowly heated to separate the fluorescent-labeled strand from the quencher-labeled strand, a process that results in an increase in the fluorescence signal. The reaction fluorescence is measured during this process and the temperature at which the change in fluorescence is the maximum is the T ,, of the amplicon. The instrument fluorescence output is analyzed and test results are determined using the ARIES® System software and the ARIES® Group A Strep Assay protocol and run files. ARIES® Group A Strep Assay results may be reported from the ARIES® Software or from the optional SYNCT® Software.

The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of toxigenic Clostridium difficile (C. difficile) nucleic acid in unpreserved, unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI). The test targets the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) and is indicated for use as an aid in the diagnosis of C. difficile infection (CDI). The ARIES® C. difficile Assay is indicated for use with ARIES® Systems.

The ARIES® C. difficile Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system which consists of the ARIES® System or the ARIES® M1 System with their included ARIES® Software, a stool resuspension kit, an assay-specific cassette, and an assay-specific protocol file. The ARIES® C. difficile Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® C. difficile Assay cassette directly detects toxigenic Clostridium difficile (C. difficile) from unformed stool specimens obtained from patients suspected of having Clostridium difficile infection. Specifically, the ARIES® C. difficile Assay cassette detects the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) and a DNA Sample Processing Control. Unpreserved raw stool is processed using the ARIES® Stool Resuspension Kit. The ARIES® Stool Resuspension Kit includes a flocked swab, a tube containing preprocessing beads, and Stool Resuspension Buffer. The preprocessing method involves transfer of a swab of stool specimen into a tube containing preprocessing beads and Stool Resuspension Buffer. The swab is mixed in the tube by vortexing and then centrifuged. Finally, the preprocessed sample is added to the ARIES® C. difficile Assay cassette. The specimen is lysed and nucleic acid is extracted using an ARIES® instrument. An extractable sample processing control (SPC) target is also present in the ARIES® C. difficile Assay cassette and is processed with the specimen. The SPC controls for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the Tm of the tcdA and tcdB targets (if present). The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® C. difficile Assay lyophilized PCR reagents in the PCR tube that contain primer pairs specific to tcdA, tcdB, and the SPC sequence. Each of the primer pairs is labeled with a distinct fluorophore and detected in distinct channels of an ARIES® System. PCR amplification is performed and assay fluorescence is monitored. Incorporation of a quencher-labeled nucleotide results in a decrease in fluorescence for the associated primer pair. Following amplification, the reaction is slowly heated to separate the fluorescent-labeled strand from the quencher-labeled strand, a process that results in an increase in the fluorescence signal. The reaction fluorescence is measured during this process and the temperature at which the change in fluorescence is the maximum Tm of the amplicon. The strands of the amplicons will separate at a specific melting temperature (Tm) and an increase in fluorescence is observed. The instrument fluorescence output is analyzed and test results are determined using the ARIES® System software and the ARIES® C. difficile Assay protocol and run files. ARIES® C. difficile Assay results may be reported from the ARIES Software or from the optional SYNCT® Software.

The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES® Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES® Bordetella Assay do not preclude B. pertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direction and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. perfussis and B. parapertussis respiratory infection with other clinical findings and epidemiological information. The ARIES® Bordetella Assay is indicated for use with the ARIES® Systems.

The ARIES® Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES® System or the ARIES® M1 System with their included ARIES® Software, an assay-specific cassette, and an assay-specific protocol file. The ARIES® Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available E-Swab™ (Nylon® Flocked Swab along with modified Liquid Amies) or a commercially available nasopharyngeal swab (i.e. rayon, flocked, nylon, plastic shaft, etc.) placed into an approved transport media (i.e UTM, M5, M6, or equivalent). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using an ARIES® System. An extractable sample processing control (SPC) target is present in the ARIES® Bordetella Assay cassette and is processed with the specimen. The SPC controls for specimen lysis, for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® Bordetella Assay lyophilized PCR reagents in the PCR tube that contains primer pairs specific to the B. pertussis toxin promoter (ptxA-pr), the B. parapertussis IS1001 insertion element, and the SPC sequence. Each of the primer pairs are labeled with a distinct fluorophore and detected in distinct channels of the ARIES® Systems. PCR amplification is performed and assay fluorescence is monitored. Incorporation of a quencher-labeled nucleotide results in a decrease in fluorescence for the associated primer pair. Following amplification, the reaction is slowly heated to separate the fluorescent-labeled strand from the quencher-labeled strand, a process that results in an increase in the fluorescence signal. The reaction fluorescence is measured during this process and the temperature at which the change in fluorescence is the maximum Tm of the amplicon. The strands of the amplicons will separate at a specific melting temperature (Tm) and an increase in fluorescence is observed. The instrument fluorescence output is analyzed and test results are determined using the ARIES® System software and the ARIES® Bordetella Assay protocol and run files. ARIES® Bordetella Assay results may be reported from the ARIES® Software or from the optional SYNCT® Software.

The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women. The ARIES GBS Assay is intended for use as a method for detection in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection. The ARIES GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

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The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems.

The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that will consist of an ARIES® System with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES® Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® Flu A/B & RSV Assay cassette directly detects and differentiates influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. Specifically, the ARIES® Flu A/B & RSV Assay cassette detects the matrix protein genes of influenza A and influenza B viruses, and the fusion gene of RSV and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using an ARIES® System. An extractable sample processing control (SPC) target is present in the ARIES® Flu A/B & RSV assay cassette and is processed with the specimen. The SPC controls for specimen lysis, for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contain primer pairs specific to influenza A, influenza B, RSV, and the SPC sequence. The specific primer pairs are labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on an ARIES® System. Incorporation of the quencherlabeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific melting temperature (Tm) that is determined by an increase in fluorescence as the strands are separated. The instrument fluorescence output is analyzed and test results are determined using the ARIES® Flu A/B & RSV Assay protocol file. A printed results report is generated.