The Roche cobas eplex RP3 identifies up to 19 viral and bacterial pathogens in under two hours, giving healthcare teams flexible diagnostic options.
RT’s Three Key Takeaways:
- Broad Pathogen Detection: The cobas eplex RP3 panel detects up to 19 viral and bacterial targets, including Bordetella pertussis, from a single nasopharyngeal swab sample.
- Customizable Testing Options: Laboratories can select from up to five panel configurations to align diagnostic testing with local prevalence, patient needs, and operational demands.
- Rapid Workflow: The automated system requires less than one minute of hands-on preparation time and delivers results in less than two hours.
Roche has secured 510(k) clearance from the FDA for its cobas eplex respiratory pathogen panel 3 (RP3), according to the company. Designed for the automated cobas eplex system, the syndromic test offers up to five customizable configurations to help clinicians quickly identify the causes of respiratory infections.
During peak respiratory seasons, healthcare facilities face heavy demand to differentiate between viral and bacterial infections that present with overlapping symptoms, the company noted in the release. Citing clinical study data, Roche stated that rapid respiratory results can reduce unnecessary antibiotic use, limit the number of secondary tests and radiographs ordered, and shorten time to patient discharge.
Diagnostic uncertainty is particularly acute in high-risk patient groups, such as older adults, young children, and immunocompromised individuals, who face elevated risks of severe respiratory complications, according to Centers for Disease Control and Prevention data cited by Roche.
“Timely and accurate respiratory testing in critical situations can guide life-saving interventions. The cobas eplex RP3 panel gives laboratories the range of testing choices they need with quick turnaround times that can make a difference in patient care,” said Dan Malarek, president and CEO of Roche Diagnostics North America.
The RP3 panel evaluates a single nasopharyngeal swab sample for common pathogens, including influenza A, respiratory syncytial virus (RSV), and SARS-CoV-2, while adding coverage for Bordetella pertussis to expand detection of bacterial illnesses, according to Roche. The assay also incorporates updated targets to improve coverage of current and recently circulating strains of influenza and SARS-CoV-2.
The platform uses an automated sample-to-answer workflow requiring less than one minute of hands-on setup time and provides qualitative results in less than two hours, the company reported. The testing options are supported on cobas eplex system software version 3.0 or higher and expand on the capabilities of the company’s RP2 panel, which had been available under FDA emergency use authorization.
