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The Acuitas® AMR Gene Panel, performed on the QIAGEN® EZ1® Advanced XL System and the OpGen Qualified QuantStudio™ 5 Real-Time PCR System, is a qualitative nucleic acid-based multiplex in vitro diagnostic test for detection and differentiation of antibiotic resistance markers to one or more antimicrobial agents. The test utilizes realtime polymerase chain reaction (PCR) and is performed on isolated colonies of Pseudomonas aeruginosa. Enteroooccus faecalis, or members of Enterobacterales grown in pure culture on blood agar or MacConkey agar. Organism identification results must be available prior to reporting results for the Acuitas AMR Gene Panel. Antimicrobial resistance gene results are reported by the Acuitas AMR Gene Panel for the combinations of bacterial pathogens and associated genetic resistance markers indicated in Table 1 below. The Acuitas AMR Gene Panel includes assays for the detection and reporting of genetic resistance markers associated with resistance to select drugs in the following antibiotic groups: aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, suffonamides, trimethoprim, and vancomycin, to aid in the identification of potentially antimicrobial-resistant organisms. The panel includes an assay for the detection of the mobilized colistin genetic determinant MCR-1, a marker of public health importance associated with reduced inhibitory activity of polymyxins. The results of the Acuitas AMR Gene Panel for detection and identification of genetic determinants associated with antimicrobial resistance are used along with the Acuitas AMR Gene Panel Electronic User Guide (EUG). In certain cases, this information may be used as an aid to clinicians in the management of patients with known or suspected antibiotic non-susceptible or resistant bacterial infections. The EUG contains information on the appropriateness of reporting resistance markers detected by the Acuitas AMR Gene Panel for claimed organisms based on the strength of the collective, totality of scientific evidence delineating the level of association between molecular marker detection with phenotypic, clinical resistance. Test results are not conclusive or prescriptive for labeled use of any specific antimicrobial drug product, and therefore, this test cannot be used in place of or to postpone or delay phenotypic antimicrobial susceptibility testing. A "Detected" or "Not Detected" result does not rule out the presence of other antimicrobial resistance markers not detected by the Acuitas AMR Gene Panel. A "Not Detected" result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes, as multiple mechanisms of resistance may exist.

The Acuitas® AMR Gene Panel is a qualitative nucleic acid-based in vitro diagnostic test capable of simultaneous detection and identification of select genetic determinants of antimicrobial resistance (AMR) in isolated bacterial colonies grown on blood agar or MacConkey agar. The test detects twenty-eight (28) genetic determinants of resistance to the following nine (9) antibiotic classes: aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, polymyxins, sulfonamides, trimethoprim and vancomycin. The assay is performed on pure colonies of Enterobacterales and Pseudomonas aeruginosa grown on blood agar or MacConkey agar along with Enterococcus faecalis grown on blood agar. The Acuitas AMR Gene Panel kit contains all of the necessary reagents for PCR and detection in order to amplify and detect DNA from pure colonies of Enterobacterales (Citrobacter freundii complex (Citrobacter braakii, Citrobacter freundii, Citrobacter werkmanii, Citrobacter youngae), Citrobacter koseri, Enterobacter cloacae complex (Enterobacter asburiae, Enterobacter cloacae, Enterobacter hormaechei, Enterobacter kobei, Enterobacter ludwigiì), Escherichia coli, Klebsiella pneumoniae, Klebsiella quasipneumoniae, Klebsiella aerogenes, Klebsiella michiganensis, Klebsiella oxytoca, Klebsiella variicola, Morganii, Proteus mirabilis, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, Raoultella planticola, Serratia marcescens) and Pseudomonas aeruginosa grown on blood agar or MacConkey agar, as well as Enterococcus faecalis grown on blood agar from clinical specimens. The test kit includes PCR plates (96-well) with dried primers and probes for analysis of four (4) isolates (24 wells per isolate). The Acuitas AMR Gene Panel assay employs automated deoxyribonucleic acid (DNA) extraction on the QIAGEN® EZ1® Advanced XL System and multiplex real-time PCR on an OpGen Qualified Applied Biosystems™ QuantStudio™ 5 Real-Time PCR System ("OpGen Qualified QuantStudio 5") for use with the Acuitas AMR Gene Panel. The QIAGEN EZ1 DSP Virus Kit has been selected for use as the sample preparation method for the Acuitas AMR Gene Panel test. After colony isolation, the user prepares a 0.5 McFarland suspension for each bacterial isolate and performs DNA extraction. DNA is extracted on the QIAGEN EZ1 Advanced XL System according to manufacturer instructions incorporating the Assay Control within the extraction process. A sample of extracted DNA eluate is transferred to a Reagent Reservoir trough to which Acuitas AMR Gene Panel Master Mix is added. Extracted DNA/Master Mix is transferred to each of 24 wells on the Acuitas AMR Gene Panel PCR plate per test sample. The contents of each well are mixed, and the plate is sealed and transferred to the OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel for real-time multiplex reaction and detection using the Acuitas AMR Gene Panel PCR Template File. Data are exported from the OpGen Qualified QuantStudio 5 and imported into the Acuitas AMR Gene Analysis Software, a spreadsheet application that analyzes the data and generates a report for viewing and printing. Each test report indicates detection of applicable antimicrobial resistance gene variants as "Detected", "Not Detected" or "NA/NR". The Applied Biosystems QuantStudio 5 Real-Time PCR System is not intended for clinical diagnostic purposes. The OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel is a component of the Acuitas AMR Gene Panel assay and is cleared for in vitro diagnostic use only with the Acuitas AMR Gene Panel and not for any other application. The OpGen Qualified QuantStudio 5 for use with the Acuitas AMR Gene Panel may only be used with the Acuitas AMR Gene Panel after the instrument has been qualified for use by OpGen, Inc.

The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakec. blaNDM, blackA-48-like, and blamp gene sequences associated with carbapenem-nonsusceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR). The GenePOC™ Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC™ Carba assay result does not preclude the presence of other resistance mechanisms. The GenePOC™ Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a bland, blaym or blaviM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-ß-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

The GenePOC™ Carba assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection and differentiation of the blaype, blayDM, blavin, blaoxA-48-ike, and blamp gene sequences in carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The GenePOC™ Carba assay is designed to be performed on the revogene™ instrument. The revogene™ is an instrument that automates sample homogenization, sample dilution, cells lysis, DNA amplification, and detection of the amplified PCR products. The GenePOC™ Carba assay kit is comprised of single-use, disposable microfluidic cartridges (PIEs), Sample Buffer Tubes (SBT), and Disposable Transfer Tools (DTT). These components are used to dilute the sample, extract, amplify, and simultaneously detect blayDM, blavin, blaoxA-48-like, and blamp DNA. A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure. Each GenePOC™ Carba assay kit contains 24 individual pouches. Each pouch has components for one (1) test including one (1) Carba PIE, one (1) SBT, and one (1) DTT. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of the blaker, blands, blaoxa-48-like, and blanyp gene sequences from isolates of pure cultures of carbapenem-non-susceptible gram-negative bacteria in approximately 70 minutes. User intervention is only required for preparing the standardized 0.5 McFarland bacterial suspension from characterized carbapenem-non-susceptible isolated colonies, inoculating the bacterial suspension into the Sample Buffer Tube (SBT), transferring the sample into the single-use disposable PIE, and loading/unloading the PIEs into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps. Upon completion of a run, the results are interpolated by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. Upon completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. The results are automatically generated at the end of the process in a report that can be viewed and printed.

The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections.

The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from isolates of pure cultures of carbapenem-non-susceptibility gram-negative bacteria. The Xpert Carba-R Assay is intended as an aid for infection control for monitoring the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System platform automates sample preparation, amplification and real-time detection. The GeneXpert Instrument Systems require the use of single-use, disposable cartridges (the Xpert Carba-R cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. The Xpert Carba-R Assay cartridges contain reagents for the detection of blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System platform. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from isolates of pure cultures of carbapenem-nonsusceptibility gram-negative bacteria in approximately 50 minutes. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-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 RT-PCR and detection. The bacterial isolates from culture are placed into a sample reagent. The sample is transferred to the sample chamber of the disposable fluidic cartridge (the Xpert Carba-R cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert instrument platform, which performs hands-off real-time, multiplex PCR for detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences. The results are automatically generated at the end of the process in a report that can be viewed and printed.