ePlex^® Respiratory Pathogen Panel 2 (RP2)

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

ePlex^® Respiratory Pathogen Panel 2 (RP2)

The ePlex^{^®} Respiratory Pathogen Panel 2 (RP2) identifies the most common viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2, the virus that causes COVID-19.

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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 is 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. 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.

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ePlex^® Respiratory 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.

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.

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Intended use

CE-IVD

The GenMark ePlex^® Respiratory Pathogen (RP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the ePlex^® System for simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals exhibiting signs and symptoms of respiratory tract infection.

The following virus types, subtypes, and bacteria are identified using the ePlex^® RP Panel: adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, 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, Chlamydia pneumoniae, 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.

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.

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.

Registration status

CE-IVD

Package inserts

GenMark IFUs can be accessed through the customer resource center.

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.

ePlex® Respiratory Pathogen Panel 2 (RP2)