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The Unyvero LRT BAL Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences from the following microorganisms (N = 20) and antibiotic resistance markers (N = 10) in bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) from adult hospitalized patients with suspected lower respiratory tract infections. The Unyvero LRT BAL Application performed on the Unyvero System is indicated as an aid in the diagnosis of lower respiratory tract infection in adult hospitalized patients with signs and symptoms of lower respiratory infection; results should be used in conjunction with other clinical and laboratory findings. As BAL specimens may contain colonizing microorganisms, detection of Unyvero LRT BAL microbial targets does not indicate that the microorganism is the disease. Unyvero positive results do not rule out co-infection with other microorganisms. Negative results do not preclude lower respiratory infection, as the causative agent may be a microorganism not detected by this test. A negative result for any antibiotic resistance marker does not indicate that detected microorganisms are susceptible to applicable antimicrobial agents. Detected antibiotic resistance markers cannot be definitively linked to specific microorganisms, and may be present in organisms that are not detected by the Unyvero LRT BAL Application. Microbiology cultures of BALs should be performed to obtain isolates for species identification and antimicrobial susceptibility testing and to identify potential microorganisms not targeted by the Unyvero LRT BAL Application.

The Unyvero LRT BAL Application automates and integrates DNA purification and eight parallel multiplex endpoint PCR reactions. It provides qualitative detection of nucleic acids from multiple lower respiratory pathogens using hybridization on PCR chamber arrays in a single use cartridge from a single bronchoalveolar lavage (BAL)-like specimen (BAL or mini-BAL). The Unyvero LRT BAL Application identifies 20 microorganisms and 10 antibiotic resistance markers as listed in the Intended Use Statement, below. The Unyvero LRT BAL Application uses a multiplex PCR approach following array hybridization which targets 30 individual analytes (microorganisms (N = 20) and antibiotic resistance markers (N = 10) divided into eight separate PCR reactions that are performed in individual reaction chambers simultaneously on a Unyvero LRT BAL Application cartridge. Multiplex compositions are designed to avoid any expected common occurrence of certain analytes within the same multiplex to largely reduce competitive PCR inhibition. Individual analyte assays of the Unyvero LRT BAL panel are designed to exhibit low or absent cross-reactivity with the relevant bronchoalveolar lavage (BAL)like specimens (BAL or mini-BAL) sample matrix or 'close neighbor' strains. Array oligonucleotides are designed for similar hybridization and melting temperatures (approx. 65 - 80 ℃, varying by amplicon). Hybridization and melting temperatures are used to exclude non-specific hybridization signals for improved signal specificity. The instrumentation consists of one (or more) Unyvero L4 Lysator, one (or more) Unyvero A50 Analyzer, a Unyvero C8 Cockpit, and four single-use consumables: the Unyvero LRT BAL Cartridge, the Unyvero Sample Tube, Sample Tube Cap and the Unyvero Master Mix. A Unyvero Sample Tube Holder is supplied as accessory to simplify the sample filling step. - Unyvero LRT BAL Cartridge contains DNA isolation and purification reagents, . primers, hybridization and wash buffers, and oligonucleotides for detection. - Unyvero T1 Sample Tube and Transport Cap contains glass beads and buffers to lyse ● microorganisms and liquefy the sample. - . Unyvero T1 Sample Tube Cap seals the Unyvero Sample Tube and contains Proteinase K and a synthetic control gene for process monitoring. - Unyvero M1 Master Mix Tube contains reagents for DNA amplification. ● An internal control (a synthetic gene without any homology to known sequences) is processed in every chamber in order to verify the DNA purification, array hybridization, and detection. Other than the built-in controls, no external materials are supplied with Unyvero LRT BAL Application devices and consumables. Good laboratory practice recommends running external positive and negative controls using samples cultured in the laboratory. No additional reagents are required to perform the Unyvero LRT BAL Application; all reagents are supplied within the cartridge or within the other consumables with the exception of the polymerase Master Mix, which is provided separately (frozen). How to perform a Unyvero LRT BAL test: - 1. Remove the Unyvero Sample Tube from its packaging and slide it in the Unyvero Sample Tube Holder in the upright position with the barcoded end at the bottom. - 2. Remove the Transport Cap from the Sample Tube by pulling it upward. - 3. Pipette 180 uL of vortexed patient specimen into the Sample Tube and close it using the Unyvero Cap provided in the LRT BAL kit: align the small nodules on the neck of the Sample Tube with the Tube with the openings on the Cap and press down to lock in place. - 4. Scan the Sample Tube and place it into the Lysator. Close the Lysator lid to start the Lysator. - 5. Remove Master Mix from freezer and thaw at room temperature (15 ℃ 25 ℃) for approximately 30 minutes. - 6. When lysis is complete, remove the Sample Tube from the Lysator and place it into the labeled position on the left-hand side of the Unyvero LRT BAL Cartridge. - 7. Place the thawed Master Mix into the labeled position on the right-hand side of the Cartridge. - 8. Scan the Cartridge on the Cockpit and insert it into the position indicated on the Analyzer. The software provides on-screen instructions to start the test. - 9. View results after completion of the run. During the automated analysis (Step 8), which is entirely controlled by the A50 Analyzer, the sample is mixed with ethanol and then transferred onto the DNA purification column, where buffers purify and elute the DNA. Eluted DNA is transferred to a chamber, where mixing with the Master Mix takes place. This mixture is distributed into eight separate PCR reaction chambers each containing multiple primer pairs, consisting of one labeled and one non-labeled primer for the respective multiplex endpoint PCR. After specific amplification, PCR products are hybridized to the corresponding array probes. Each array has been manufactured with probes corresponding to the amplicons for the targeted microorganism sequences described above. A total of up to 49 spots per array allows for redundant detection with at least four spots per analyte, as well as spots for intensity calibration, and orientation markers for the image processing software. Binding of amplicons to specific probes is detected by analyzing fluorescence images of the arrays. Result data are displayed on the C8 Cockpit for visualization, printout, temporary storage and electronic data export. A test run is completed after 4 to 5 hrs, and results for panel microorganisms and corresponding antibiotic resistance markers are displayed on the Cockpit screen. Four screens are provided: - . The Result Summary screen provides a quick overview of all detected LRT BAL panel microorganisms, together with all detected corresponding antibiotic resistance markers. - . The Microorganisms screen provides a list of all panel microorganisms grouped in Grampositive bacteria, non-fermenting bacteria, Enterobacteriaceae and other microorganisms together with the analysis result (reported as detected, not detected or invalid). - The Result Details screen provides a list of all analyzed microorganisms and the ● corresponding antibiotic resistance markers together with the analysis result (reported as detected, not detected, invalid or NA). - Test Details screen showing user name, lot numbers of used consumables, expiration dates of ● the consumables and start and stop times and dates of the test. Results can be reviewed on the cockpit or, optionally, be printed out. All results are saved in a database on the Unyvero Cockpit for later review and printing. The Unyvero software is designed to: - Manage analysis workflow (Cockpit) ● - Carry out sample lysis (Lysator) ● - Execute the analysis and generate the analytical result (Analyzer) . - Manage communication among units (Cockpit, Lysator, Analyzer) ● - Monitor internal mechanical / electrical actuators (Lysator, Analyzer) ● - Present analysis results (Cockpit) . - Store analysis results (Cockpit) ● Each device (Cockpit, Lysator. Analyzer) is a subsystem within the overall system, and each consists of hardware and software components. The different devices are interconnected by an Ethernet based communication interface, and system functionality is provided by the interaction of all three device types. Only the Cockpit presents a rich user interface and allows interaction with the operator. The Lysator and Analyzer units include a simple display for showing device status. Optional HIS/LIS connectivity allows transferring results to a hospital or laboratory information system.

The Unyvero LRT Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences from the following microorganisms and antibiotic resistance markers in endotracheal aspirates from adult hospitalized patients with suspected lower respiratory tract infections. The Unyvero LRT Application performed on the Unyvero System is indicated as an aid in the diagnosis of lower respiratory tract infection in adult hospitalized patients with signs and symptoms of lower respiratory infection: results should be used in conjunction with other clinical and laboratory findings. As tracheal aspirates commonly contain colonizing microorganisms, detection of Unyvero LRT microbial targets does not indicate that the microorganism is the cause of the disease. Unyvero positive results do not rule out co-infection with microorganisms not detected by the Unyvero LRT Application. Negative results do not preclude lower respiratory infection, as the causative agent may be a microorganism not detected by this test. A negative result for any antibiotic resistance marker does not indicate that detected microorganisms are susceptible to applicable antimicrobial agents. Detected resistance markers cannot be definitively linked to specific microorganisms, and may be present in organisms that are not detected by the Unyvero LRT Application such as organisms present as colonizing or normal flora. Microbiology cultures of aspirates should be performed to obtain isolates for species identification and antimicrobial susceptibility testing, to differentiate quantities of identified microorganisms as well as normal flora present in the specimen and to identify potential microorganisms not targeted by the Unyvero LRT Application.

The Unyvero LRT Application is a qualitative test that includes specimen processing, genomic bacterial DNA isolation and purification, multiplex PCR and array hybridization and detection. The Unyvero LRT Application performed using the Unyvero System detects specific nucleic acid sequences from microorganisms and resistance markers in tracheal aspirates collected from patients with signs and symptoms of lower respiratory infection. The Unyvero LRT Application consists of the following components: - Unyvero LRT Cartridge: Contains DNA isolation and purification reagents, a DNA isolation column, eight separate PCR chambers with eight corresponding detection arrays. The Cartridge also contains fluorescently-labeled primers, hybridization and wash buffers and oligonucleotide probes for detection of targeted PCR products using array hybridization technology. - Unyvero T1 Sample Tube: Contains glass beads and buffers to lyse bacteria and liquefy the sample. - Unyvero T1 Sample Tube Cap (with Internal Control): Contains proteinase K and a synthetic internal control gene for process monitoring. The T1 Sample Tube Cap seals the Unyvero Sample Tube after which the internal control is combined with each patient specimen. The internal control DNA sequence does not have significant homology to targeted sequences and is amplified independently in each of the eight PCR chambers and the amplified internal control product is hybridized on each array. - Unyvero M1 Master Mix: Contains reagents for DNA amplification. - Unyvero T1 Transfer Tool: The Transfer tool can be used to transfer viscous specimens from the primary sample container to the Unyvero Sample Tube. The Unyvero System consists of the following components: - Unyvero Lysator: The Lysator lyses the specimen and can process up to four specimens simultaneously in four separate slots. - Unyvero Analyzer: The Analyzer automates DNA purification, amplification and detection. Each Analyzer can simultaneously process up to two Unyvero Cartridges with each slot available using random access. - Unyvero Cockpit: The Cockpit provides the main user interface for the Unyvero System, guides the user through the steps to run the Unvvero LRT Application and automatically generates and displays test results. The Cockpit is equipped with a high-resolution touch screen and a barcode reader. - Unyvero Sample Tube Holder: The Sample Tube holder holds the Sample Tube securely while the specimen is transferred into the Sample Tube.