ePlex® System

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

GenMark ePlex System
True sample-to-answer solution

The ePlex® System sample-to-answer solution streamlines the diagnostic workflow from your order entry to the release of the final report.


True Sample-to-Answer workflow
 

  • Bi-directional LIS to automate and accelerate order entry and results reporting
  • Random and continuous access and a modular, scalable design to
    ensure capacity that meets peak season demand
  • Independently validated shortest hands-on time in the lab
  • Remote alerts to notify you test results are available
  • Intuitive user interface with guided workflows to enable operation on every shift
  • Remote service capability to minimize system downtime and ensure patients and physicians have access to rapid test results


Order-to-report is what matters most:

Order to Report

 

The green time stamps are commonly documented in hospital and laboratory information systems. The ePlex® System is designed for order-to-report with a lean workflow by eliminating manual steps and staging of samples that often delay and complicate efficient test processing and results reporting.

While many systems claim sample-to-answer capabilities, only the ePlex® System integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics. The ePlex® System offers many unique solutions that were thoughtfully engineered to address the biggest challenges facing you in the clinical laboratory and to support hospital systems in delivering patient centered, value-based care.

ePlex system integration

Preventable medical errors are now the third leading cause of death in the United States at more than 250,000 per year.1 Automating information transfer has been shown to be effective in reducing many common errors, including patient identity checking and order transcription.2 The ePlex® System is uniquely designed with patient safety features in mind so that labs and physicians can have the confidence that they have the right patient, with the right test, and the right result, every time.

  • Reduce the chance of pre-analytical errors with the shortest hands-on time and guided workflows

  • Transcription errors can be eliminated in both order entry and result reporting with bi-directional LIS

Monitoring and reporting quality control testing is both a requirement and a best practice to ensure accuracy of patient results and compliance with lab standards. With on-board QC tracking capabilities and safeguards, you can not only run controls when required, you can also easily track and report compliance. In addition to automated QC tracking, the 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

All of these unique capabilities of the ePlex® System 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.

A modular and scalable system
Product-ePlex-NP

 

ePlex® System NP (Near Patient)

  • 3 test bays
  • 36 patient samples per day*
Product-ePlex-1-Tower

 

ePlex® System 1 Tower

  • 6 test bays
  • 72 patient samples per day*
Product-ePlex2-Tower

 

ePlex® System 2 Tower

  • 12 test bays
  • 144 patient samples per day*
eplex-3-tower

 

ePlex® System 3 Tower

  • 18 test bays
  • 216 patient samples per day*
Product-ePlex-4-Tower

 

ePlex® System 4 Tower

  • 24 test bays
  • 288 patient samples per day*

*Based on 24 hour day

ePlex® System specifications

ePlex-System-specifications-modular-and-scalable

 

WEIGHT 1-Tower System 49kg (108 lbs)
DIMENSIONS 1-Tower System 59 cm x 48 cm x 54 cm (23.5” x 19.0” x 21.3”)
LIS COMPATIBILITY ASTM LIS 1-A & LIS 2-A2 (Bi-directional) HL7 v2.3 (Bi-directional) Flat File (.csv, .xml and .txt)
SUPPORTED BARCODES Aztec, Codabar, Code 39, Code 93, Code 128, Data Matrix, EAN, Interleaved 2 of 5, JAN, MaxiCode, UPC
POWER REQUIREMENTS 100-240 Vac, 50/60 Hz, 265W
ENVIRONMENTAL CONDITIONS Ambient Temperature: 15 – 30°C Relative Humidity: 15 – 85% (Non-condensing)
NOISE GENERATION ≤ 60dBA

Registration status

CE-IVD, US-IVD 

 

Package inserts

GenMark ePlex® System user guide can be accessed through the customer resource center.

References:

  1. Martin A Makary, Michael Daniel. Medical error—the third leading cause of death in the US. BMJ, 2016; i2139 DOI: 10.1136/bmj.i2139
  2. The National Academics of Sciences Engineering Medicine. https://www.nap.edu/read/9728/chapter/4#39. Accessed April 20, 2017
 
ePlex® Panels, System and Software are developed and manufactured by GenMark GenMark Diagnostics, Inc. and distributed by Roche.



Software designed to improve efficiency and patient care

The ePlex® Software combines intuitive user interface with the customization freedom required to support the diverse and dynamic needs of laboratory and healthcare systems. The software is designed to streamline tasks across the diagnostic process from order-to-report, improving productivity at every level.

Laboratory Information System (LIS) Reporting

ePlex® Software improves order-to-report turnaround time, reduces labor costs, and eliminates potential transcription errors with industry leading bi-directional LIS capabilities. ePlex® Software utilizes hospital standard messaging protocols allowing for broad compatibility across LIS providers.

Bi-directional LIS is one aspect of the unique compliance and data management solution that ePlex® Software offers your institution.  Benefits of our integrated solution include:

  • Automated result reporting eliminates transcription errors and ensures actionable results are returned to physicians as soon as possible

  • Configurable auto-validation and eSignature optimize workflow and improve lab efficiency

  • Reduction in pre- and post-analytical steps improve time to results and minimizes the risk of avoidable error


ePlex® Software is the only sample-to-answer solution on the market today that offers true bi-directional LIS capability based on industry standards to optimize performance in your lab.

Laboratory-Information-System

 

Supported Interfaces

  • HL7
  • ASTM
  • CSV, XML, TXT (Non-Standard)

Explore the ePlex® Software details

templated comments
Templated comments
 

Templated comments can drive more rapid therapy decisions

  • Defined by the laboratories based on appropriate clinician decisions
  • Automate the interpretation of the local antibiogram to guide antibiotic therapy selection
  • Fast-track treatment intervention improving antimicrobial stewardship programs and infection control
templated comments rule builder
Templated comments rule builder
 

Allows rules to be imported across multiple instruments

  • You can prepare multiple simple templated comments from the convenience of your desk

  • You can create a master file of simple rules, save as a .CSV, then upload the file to the instrument

report scheduler
Report scheduler
 

Integrated scheduling tool that automates the generation and distribution of report results

  • Customized epidemiology reports with automated distribution scheduled daily, weekly or monthly

  • Reports can be distributed via email to minimize the administrative overhead of gathering data

Custom Epidemiology Reports
Custom epidemiology reports


Integrated epidemiology reporting to help analyze onboard prevalence data

  • Create customized reports for surveillance and monitoring of epidemiology data

  • Export custom epidemiology datasets to excel compatible formats to create multi-series prevalence charts

ePlex-SystemScreen-5-Laboratory-Information-System
Laboratory Information System (LIS)
 

Bi-directional LIS integration improves result turnaround time and helps reduce transcription errors

  • Pending test orders dashboard enables immediate visibility of incoming samples to determine daily workload

  • Integrated auto-validation control to manage automatic result release to LIS

  • Drivers available for all major LIS vendors

ePlex-System-Screen6-External-Control
External control

 

Automated QC tracking to ensure accreditation compliance

  • Easily demonstrate QC compliance for lab accreditation with onboard reporting

  • Predefine and track external quality control by assay

  • Automatically monitor QC frequency and lot changes

  • External control workflow provides the user with the ability to reset the due dates in the middle of an existing external control cycle

ePlex-SystemScreen-7-Security-and-User-Management
Security and user management

 

Integrated HIPAA compliant safeguards to manage security risks and vulnerabilities

  • User access management to the ePlex® System is simplified with active directory integration

  • Strong password requirements are enforced to help protect electronic protected health information (ePHI)

3HePlex-SystemScreen-8-Bay-Monitoring
Bay monitoring

 

Automated bay monitoring to ensure bay health status

  • Designed to improve validity by identifying bay-related issues early

We are committed to being your long term partner and helping you provide the best service to your institution and patients.  Not only can you reach our industry leading technical support team, but they can also reach directly into your lab if you choose to enable our unique remote access capabilities on the ePlex® System.

Remote access provides an innovative, proactive and easy-to-use utility to support ePlex® Systems in your lab. This tool establishes a secure network connection between the technical support team and the ePlex® Instrument. Support through remote access ensures timely resolution of issues with minimal impact to lab workflow all while maintaining the security of patient data and laboratory operations.

Remote access is just another way that ePlex® Software is optimized for the lab by providing a unique service capability that enables:

  • On-demand remote troubleshooting and log transfer
  • Enhance service response and issue resolution time
  • Reduce site operator time assisting with issue resolution
  • Analyze system performance
  • Review instrument configuration settings

GenMark, like Roche, is committed to the integrity of Protected Health Information (PHI) and the security of customer networks and information systems. ePlex®  Software remote access is equipped with an advanced suite of security features.

  • Secured data transfer using 256-bit Advanced Encryption Standard (AES) SSL
  • Connections established only with site operator approval
  • HTTPS PORT 443 to securely connect with dedicated GenMark support server
  • Data does not contain ANY identifiable patient data
  • Meets CLSI security standard for remote connections in your laboratory

 

ePlex® Panels, System and Software are developed and manufactured by GenMark GenMark Diagnostics, Inc. and distributed by Roche.



Report patient results with confidence

Reduce avoidable medical errors to improve patient safety

Preventable adverse patient outcomes or injury present a serious public health concern and an enormous threat to patient safety.1 Recently, a study found that medical error is the third leading cause of death in the United States, equating to more than 250,000 deaths per year.2

GenMark, like Roche, is committed to the continued improvement of patient care. The unique solutions on the ePlex® System helps to improve patient safety across the pre-analytical, analytical and post-analytical phases of the diagnostic process, of which up to 70% of clinicians base their decisions.3 The ePlex® System is designed to automate typically manual procedures that can potentially lead to human errors, such as accessioning of patient samples, and the manual transcription of patient results into a Laboratory Information System (LIS).

The ePlex® System is designed to be both efficient and safe to ensure that every clinician and their patient have the best opportunity of receiving a fast, reliable and actionable result. The ability to report patient results with confidence helps improve the overall efficiency of your lab, leading to potentially institution-wide benefits to those running the ePlex®  System.4

Address common sources of medical error using the ePlex® System

From the moment a test is requested, a patient specimen must be correctly identified, labelled, and tracked. It is in this phase that the majority of errors occur, as the specimen may need to be transported to the site where the testing itself is performed.5 Having the ability to track pending test orders, allows the ePlex® System to potentially decrease the probability of lost, misplaced or delayed specimens.

  • Test cartridge chain of custody – direct placement of barcode on test cartridge to reduce potential for mismatched results.
  • Simple, lean workflow – least number of pre-analytical steps to reduce likelihood of human error and technician fatigue.6
  • Pending test orders – automated download of test orders can notify of lost, misplaced or delayed samples.

During this phase, the patient sample is tested. It is critical that there are necessary QC procedures in place to ensure there are no undetected failures that would lead to incorrect test results. The ePlex® System automates QC tracking and onboard reporting to ensure reliable results as well as compliance with the correct accreditation requirements.

  • Automated QC tracking and onboard QC reporting – assist in accreditation program compliance and ensure that patient samples are run on valid controls through configurable process control settings.
  • QC frequency reminders – automated adherence and tracking of QC frequency.
  • Expiration date process control – test cartridge pre-programmed with expiration date and checked upon loading to prevent use of expired reagents.

Patient results must be communicated quickly and accurately to the appropriate personnel, as a failure or delay in reporting can lead to adverse patient effects. Automation tools can greatly minimize errors that occur in this stage as they reduce the need for manual transcription. The ePlex® System’s bi-directional LIS capabilities allow users to auto-transcribe results and auto-release specific results, reducing overall turnaround time.

  • Bi-directional LIS – improves and standardizes turnaround time by automating the results release process and eliminating transcription errors.
  • Customizable auto-release reporting – automatically send specific results to the LIS and reduce overall turnaround time, leading to more actionable information and timely patient care.

References:

  1. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al. Incidence of adverse events
  2. Daniel M, Makary M. Medical error—the third leading cause of death in the US. BMJ. 2016;353:i2139. and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-6
  3. Forsman RW. Why is the laboratory an afterthought for managed care organizations? Clin Chem. 1996; 42(5):813-816
  4. ECRI Institute Names Top 10 Patient Safety Concerns for 2017. https://www.ecri.org/press/Pages/Top- 10-Patient-Safety-Concerns-for-2017.aspx. Published March 13, 2017
  5. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53(7):1338-1342
  6. Comparison of sample-to-answer systems - Nanosphere Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) package insert. 027-00030-01, Rev. B; October 2012. | bioMerieux BioFire Blood Culture Identification 2 (BCID2) Panel package insert. RFIT-PRT-0841-02 June 2020.

 

ePlex® Panels, System and Software are developed and manufactured by GenMark GenMark Diagnostics, Inc. and distributed by Roche.