ePlex^® Respiratory Pathogen Panel 2

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 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 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 co-infection 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 ePlex^® RP 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 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.

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 samples.

Due to the genetic similarity between human rhinovirus and enterovirus, the ePlex^® RP2 Panel cannot reliably differentiate them. If differentiation is required, a positive human rhinovirus/enterovirus result may be followed-up using an alternative method.

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) 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 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 patientmanagement 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.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency use Authorization (EUA) for use by authorized laboratories. This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2 and multiple respiratory viral and bacterial organisms and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

CE-IVD, FDA-EUA

Access package inserts through your country’s Roche Diagnostics local website.

As genetic surveillance of SARS-CoV-2 strains circulating globally continues to identify new variants and mutations that can potentially impact detection by nucleic acid-based testing methods, GenMark continues to monitor the evolution of SARS-CoV-2 variants and remains committed to providing laboratories with high-quality testing solutions that aid in the diagnosis of patients with SARS-CoV-2. In silico analyses have been continuously performed since the onset of the pandemic and continue to conclude that the ePlex^® Respiratory Pathogen 2 Panel (RP2 Panel) will detect all analyzed SARS-CoV-2 sequences in NCBI and GISAID databases.

The ePlex^® RP2 Panel targets 2 unique regions of the N (nucleoprotein) gene. Mutations in other regions of the genome, such as the spike protein or envelope protein, have no impact on the performance of the SARS-CoV-2 assays on the ePlex^® RP2 Panel. The bioinformatic assessment includes expected performance of both the N1 and N2 SARS-CoV-2 assays for any mutation located within the gene regions targeted by these assays.

The table below summarizes SARS-CoV-2 variant strains and the impact, if any, on the ePlex^® RP2 Panel based on bioinformatic analysis.

• This list will be updated as new information becomes available.
• This list is not intended to be a comprehensive list of all variants or mutations identified; it includes the most prevalent variants in circulation believed to be clinically significant. Strains no longer circulating and strains no longer being monitored have been removed from the table.
• For the most up to date information on variants, please refer to your regional health authorities.
  

Please contact your medical and scientific affairs specialist for questions.