ePlex® Respiratory Pathogen Panel 2

Bringing the power of GenMark ePlex® System syndromic panels together with Roche

GenMark ePlex RP2 panel
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Comprehensive pathogen coverage impacts patient care

The ePlex® RP2 Panel identifies and detects more than 20 of the most common respiratory viruses and bacteria causing respiratory illness in about 90 minutes, allowing doctors to make informed patient care decisions faster. Rapid diagnosis may be important for people who are more likely to become seriously ill from complications or require hospitalization, such as young children, adults 65 and older, pregnant women and those with compromised immune systems.

The emergence of SARS-CoV-2 in late 2019 sparked a global pandemic, with cases and deaths continuing to rise. The high mortality associated with COVID-19 and the need for rapid isolation to reduce spread and prompt initiation of treatment makes it more critical than ever to quickly identify the cause of respiratory infections.

 

Co-circulation of pathogens during respiratory illness season

 

During the annual respiratory illness season when infections tend to peak (October through March in the northern hemisphere and April through September in the southern hemisphere),1 influenza is often the first virus people think of. Globally, the WHO estimates there are 3 to 5 million cases of severe illness due to seasonal influenza, and 290,000 to 650,000 deaths annually.2 Other viruses, such as Respiratory Syncytial Virus (RSV) and metapneumovirus, are also more prevalent at certain times of the year, while others, like adenovirus and rhinovirus, are common year-round.3,4 No seasonality for SARS-CoV-2 has been identified yet and infections are expected to remain elevated during respiratory illness season.

 

Why use syndromic testing?

 

We believe the syndromic approach to diagnosis of infectious diseases can result in:

  • Better patient outcomes
  • More rapid infection control
  • Hospital bed management actions
  • Improved patient satisfaction


By detecting the most common pathogens that cause disease together on a single rapid test, with a single patient sample, you can prescribe the right therapeutic within hours – rather than days, when compared with conventional testing algorithms.
 

Comprehensive testing with a syndromic respiratory panel ensures that clinicians get the information they need to make an informed decision. This can mean that a patient avoids unnecessary antibiotic treatment, and the possible adverse side effects that may be caused by them. Reducing unnecessary use of antimicrobials also aids in antimicrobial stewardship.

ePlex® Respiratory Pathogen Panel 2 targets
Adenovirus Influenza A H1-2009
Coronavirus 229E
Influenza A H3
Coronavirus HKU1
Influenza B
Coronavirus NL63
Parainfluenza 1
Coronavirus OC43 Parainfluenza 2
SARS-CoV-2 Parainfluenza 3
MERS-CoV Parainfluenza 4
Human Bocavirus Respiratory Syncytial Virus A
Human Metapneumovirus Respiratory Syncytial Virus B
Human Rhinovirus/Enterovirus Bordetella pertussis

Influenza A

Legionella pneumophila
Influenza A H1 Mycoplasma pneumoniae


ePlex® RP2 Panel available in the US under Emergency Use Authorization (EUA) includes Chlamydia pneumoniae, and does not include MERS-CoV, Human Bocavirus, Bordetella pertussis or Legionella pneumophila. 

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® RP 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.

For In Vitro Diagnostic Use.

ePlex® System

ePlex® System

True sample-to-answer solution

The ePlex® System integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.

References

  1. World Health Organization. How can I avoid getting the flu? https://www.who.int/news-room/q-a-detail/how-can-i-avoid-getting-the-flu (Last updated January 2020).
  2. World Health Organization. Influenza (Seasonal). https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal) (accessed December 2020).
  3. Ronald B. Turner, Rhinovirus: More than Just a Common Cold Virus, The Journal of Infectious Diseases, Volume 195, Issue 6, 15 March 2007, Pages 765–766, https://doi.org/10.1086/511829
  4. Centers for Disease Control and Prevention. The National Respiratory and Enteric Virus Surveillance System (NREVSS). https://www.cdc.gov/surveillance/nrevss/index.html. Last updated Jul 12, 2022.