Syndromic testing

True sample-to-answer solution for high-risk patients.

The value of syndromic testing: The more you detect, the better you protect

Syndromic and point-of-care molecular diagnostic testing methods have transformed the landscape of infectious disease diagnostics. These methods enable rapid and simultaneous identification of multiple pathogens and drug resistance mechanisms directly from clinical specimens and positive blood cultures, streamlining the diagnostic process and offering benefits in clinical value and laboratory efficiency.^1,2

Clinical value:

Comprehensive diagnosis: Syndromic panels detect pathogens that cause overlapping signs and symptoms, providing critical care management information when there is not enough data to determine what specific pathogens to test for.
Accurate and fast results: Multiplex PCR testing enables timely decision making compared to conventional testing methods, which can help achieve improved patient outcomes.²
Antimicrobial stewardship: Syndromic testing can promote more targeted microbial treatment,³ reducing potential adverse events from the misuse and overuse of antibiotics and supporting global efforts in antimicrobial stewardship.^1,2,4

Laboratory efficiency:

Reduced hands-on time and operator errors: The simultaneous generation of multiple results in a single test reduces operator hands-on time and the potential introduction of manual errors compared with conventional diagnostic methods.²
Elimination of unnecessary tests: Syndromic testing can help laboratories reduce unnecessary additional or reflex tests, improving overall efficiency and reducing the workload and resource consumption in the lab.

Roche is committed to the continued improvement of patient care using syndromic testing. Our syndromic testing solutions, featuring the cobas® eplex system, are designed to ensure that healthcare providers and their patients have the best opportunity of receiving a fast, reliable, and actionable result.

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IVD

cobas^® eplex system

The cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.

IVD

cobas<sup>®</sup> eplex blood culture identification Gram-Negative panel

cobas® eplex BCID-GN panel

The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.

cobas® 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 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 requirementsto 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, humanrhinovirus/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 specimensduring 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 respiratoryinfection 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 combinedwith clinical observations, patient history, and epidemiological information. Negative results for other organisms detected by thetest 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 upusing 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 orlocal 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.

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Benefits of syndromic testing solutions from Roche

Optimization
Reduce errors
Efficiency

Designed for the patient, optimized for the lab

While many systems claim sample-to-answer capabilities, only the cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics for syndromic testing.

The cobas eplex system offers many unique solutions that were thoughtfully engineered to address the biggest challenges you face in the clinical laboratory and to support hospital systems in delivering patient-centered, value-based care.

Designed for the patient: reduce avoidable medical errors

Preventable medical errors are now the third leading cause of death in the United States at more than 200,000 per year.⁵ Automating information transfer has been shown to be effective in reducing many common errors, including patient identity checking and order transcription.⁶

The cobas eplex system is uniquely designed with patient safety features in mind so that labs and physicians are confident they have the right patient, with the right test, and the right result, every time.

Reduce the chance of pre-analytical errors with < 1 minute hands-on time and guided workflows
Transcription errors can be eliminated in both order entry and result reporting with bi-directional laboratory information system (LIS)

Optimized for the lab: maximize lab efficiency by reducing administrative overhead

Monitoring and reporting quality control (QC) testing is both a requirement and a best practice to ensure accuracy of patient results and compliance with lab standards. With built-in QC tracking capabilities and safeguards, you can effortlessly run controls as needed, as well as easily track and report compliance.

In addition to automated QC tracking, the cobas eplex system provides the following compliance and data management tools:

Integrated data analytics to easily monitor lab performance
On-demand epidemiology reports for export and simplified analysis
Fully configurable, auto-release of test results

These unique capabilities allow you to reduce the time spent on routine administrative tasks and focus your limited resources on high-value activities that impact patient care and the bottom line.

Syndromic testing

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Benefits of syndromic testing solutions from Roche

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