Syndromic testing

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.

The cobas eplex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on cobas eplex Instrument for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The cobas eplex BCID-FP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organism.The following fungal organisms are identified using the cobas eplex BCID-FP Panel: Candida albicans, Candida auris, Candida dubliniensis, Candida famata, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Cryptococcus gattii, Cryptococcus neoformans, Fusarium and Rhodotorula.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 the cobas eplex BCID-FP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.Negative results in the setting of a suspected bloodstream infection may be due to 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 the cobas eplex BCID-FP Panel 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 cobas eplex BCID-FP Panel, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.