The ePlex® Respiratory Pathogen Panel 2 (ePlex RP2 Panel) is a multiplexed nucleic acid in vitro diagnostic test intended for use on the 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) in 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 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 ePlex RP2 Panel may not be the definite cause of disease.
Laboratories within the United States and its territories are required to report all results for SARS-CoV-2 to the appropriate public health authorities.
Negative results for SARS-CoV-2 and other organisms on the 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 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.
Testing with the ePlex RP2 Panel is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the ePlex system. The ePlex RP2 Panel is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Due to the genetic similarity between human rhinovirus and enterovirus, the ePlex RP2 Panel cannot reliably differentiate them. If differentiation is required, an ePlex RP2 Panel positive human rhinovirus/enterovirus result should be followed-up using an alternative method (e.g., cell culture or sequence analysis).
Performance characteristics for influenza A were established when influenza A H1-2009 and A H3 were the predominant influenza A viruses in circulation. Performance of detecting influenza A may vary if other influenza A strains are circulating or a novel influenza A virus emerges. 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.