For in vitro diagnostic use. Others cobas eplex RP panel 2 IVD cobas® eplex respiratory pathogen panel 2 PID00000004 09 556 486 001 9 556 486 001 09556486001 9556486001 09556486001 COBAS EPLEX RESP PATH 2 CEIVD 12T ePlex Respiratory Pathogen Panel 2 00857167005375 Reagents, kits EA001232 1 kit 12 tests true The cobas® eplex respiratory pathogen panel 2 (RP2 Panel) is a multiplexed nucleic acid in vitro diagnostic test intended for use on the cobas® eplex Instrument for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms, including nucleic acid from Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), in nasopharyngeal swabs (NPS) eluted in viral transport media obtained from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and the targeted respiratory viral and bacterial organisms can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform moderate or high complexity tests. The cobas® eplex RP2 panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following virus types, subtypes, and bacteria: adenovirus, coronavirus (229E, HKU1, NL63, OC43), SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, influenza A, influenza A H1, influenza A H1-2009, influenza A H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus (RSV) A, respiratory syncytial virus (RSV) B, Chlamydia pneumoniae, and Mycoplasma pneumoniae. SARS-CoV-2 RNA and nucleic acids from the other respiratory viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection aids in the diagnosis of respiratory infection when used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results are indicative of active infection with the identified respiratory pathogen but do not rule out infection or co-infection with non-panel organisms. The agent detected by the cobas® eplex RP2 panel may not be the definitive cause of disease. Negative results for SARS-CoV-2 and other organisms on the cobas® eplex RP2 panel may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by a nasopharyngeal swab specimen. Negative results do not preclude infection with SARS-CoV-2 or other organisms on the cobas® eplex RP2 panel and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results for other organisms detected by the test may require additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) when evaluating a patient with possible respiratory tract infection. The cobas® eplex RP2 panel is intended for use by qualified clinical laboratory personnel specifically instructed and trained in performing testing on the cobas® eplex system and in vitro diagnostic procedures. The cobas® eplex RP2 panel is only for use under the Food and Drug Administration’s Emergency Use Authorization. en The cobas® eplex respiratory pathogen panel 2 (RP2 panel) is a multiplexed nucleic acid in vitro diagnostic test intended for use on the cobas® eplex system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasopharyngeal swabs (NPS) in transport media obtained from individuals suspected of coronavirus disease 2019 (COVID-19) or respiratory infection by their healthcare provider. The following virus types, subtypes, and bacteria are identified using the cobas® eplex RP2 panel: adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Middle East Respiratory Syndrome Coronavirus (MERS-CoV), human bocavirus, human metapneumovirus, human rhinovirus/enterovirus, influenza A, influenza A H1, influenza A H1-2009, influenza A H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus (RSV) A, respiratory syncytial virus (RSV) B, Bordetella pertussis, Legionella pneumophila, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection aids in the diagnosis of respiratory infection when used in conjunction with other clinical and epidemiological information. Results are for the detection of nucleic acid from SARS-CoV-2 and other respiratory pathogens that are detectable in NPS specimens during infection. Positive results are indicative of active infection with the identified respiratory pathogen; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude respiratory infection due to other non-panel organisms and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the cobas® eplex RP2 panel may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) and clinical presentation must be taken into consideration in the final diagnosis of respiratory tract infection. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the cobas® eplex RP2 panel may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) may be necessary when evaluating a patient with possible COVID-19. en The cobas® eplex system automates all aspects of nucleic acid testing including extraction, amplification, and detection, combining electrowetting and eSensor technology in a single-use cartridge. eSensor technology is based on the principles of competitive DNA hybridization and electrochemical detection, which is highly specific and is not based on fluorescent or optical detection. Electrowetting, or digital microfluidics, uses electrical fields to directly manipulate discrete droplets on the surface of a hydrophobically coated printed circuit board (PCB). Sample and reagents are moved in a programmable fashion in the ePlex cartridge to complete all portions of the sample processing from nucleic acid extraction to detection. A sample is loaded onto the cobas® eplex cartridge, and nucleic acids are extracted and purified from the specimen via magnetic solid phase extraction. For RNA targets, a reverse transcription step is performed to generate complementary DNA from the RNA, followed by PCR to amplify the targets. Exonuclease digestion creates single-stranded DNA in preparation for eSensor detection. The target DNA is mixed with ferrocene-labeled signal probes that are complementary to the specific targets on the panel. Target DNA hybridizes to its complementary signal probe and capture probes, which are bound to gold-plated electrodes, as shown below in Figure 1. The presence of each target is determined by voltammetry which generates specific electrical signals from the ferrocene-labeled signal probe. Figure 1: Hybridization complex. Target-specific capture probes are bound to the gold electrodes in the eSensor microarray on the cobas eplex cartridge. The amplified target DNA hybridizes to the capture probe and to a complementary ferrocene-labeled signal probe. Electrochemical analysis determines the presence or absence of targets using voltammetry. en

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