Revolutionising Molecular Enteric Testing
The EntericBio system is the market leader in its segment in the UK/Ireland and provides medium/high throughput labs with a rapid, reliable and easy to use solution for their enteric pathogen testing needs.
The EntericBio® system is unique as it is capable of detecting target DNA and RNA directly from stool specimens, circumventing the requirement for commercial nucleic acid extraction purification and minimises hands on time for the laboratory personnel.
The EntericBio® system provides a complete and flexible modular menu for enteric testing, detecting and identifying GI pathogens including Bacteria, Parasites, CPE and Viruses within the same work-flow and platform with a result for up to 46 specimens in <3 hours and results for consecutive runs each hour.
Benefits for the Lab Scientist
Easy to use
Suitable for all levels of staff with no requirement for previous molecular experience. Now including revolutionary artificial intelligence software.
Test direct from specimen
No requirement for nucleic acid extraction/purification procedures or equipment.
Ready to use
All assays are provided in the same freeze dried, room temperature stable and ready to use format.
Minimal hands on time
30 mins to process 46 patient specimens, inclusive of all processing steps from sample to result.
Time to result
1-46 samples can be processed every hour with first results available in less than 3 hours.
Unified platform & workflow
All assays are provided in the same format and are processed through a unified platform and workflow.
Increase of 94% compared to conventional microbiology methods.
Benefits for the Patient and Public Health
Improved sensitivity, specificity & coverage
Improved sensitivity, specificity & coverage of difficult to detect organisms, species or genetic variants compared to traditional methods.
Timely patient management
Early and accurate diagnosis is the first vital step in managing gastrointestinal infections and control of antibiotic resistant organisms.
Appropriate patient management
Improved antibiotic stewardship and informed patient treatment plans.
Targeted infection control
Targeted infection control patient isolation and bed management.
Enabling public health management
Enabling public health management of disease outbreaks & rapid and accurate implementation of food safety response.
Benefits for the Laboratory
Complete & modular assay menu
All significant enteric pathogen are provided under a unified platform and workflow.
Scalable & high throughput
1-46 specimens per run with a continuous processing capacity of 46 samples every hour.
Robust & reliable
Mean time before failure is >50 months for EntericBio equipment with <2% specimen inhibition/failure rate.
Small and modular footprint provides flexibility for placement in any lab.
All assays come with 24months stability and no requirement for frozen storage.
Full IQ/OQ & PQ support with ongoing class leading real time technical support provided by our lab scientists to your lab scientists.
88% reduction in clinical waste & up to 85 % reduction in consumable storage compared to conventional microbiology methods. All packaging is manufactured using a minimum of 80% recycled material.
For heat treatment of EntericBio SPS tubes.
For automated EntericBio reaction set up.
Roche Lightcycler® 480
Amplification and detection of target organisms using EntericBio proprietary analysis software.
Applied Biosystems® 7500 Fast Real-Time PCR System
Amplification and detection of target organisms using EntericBio proprietary analysis software.
Ancillary Laboratory Items
Centrifugation of EntericBio reaction wells.
EntericBio realtime Test Kit
Test kit for 240 tests.
EntericBio realtime SPS Kit
EntericBio Stool Preparation Solution.
240 Tubes of 4ml tubes with pierceable cap
SARS-COV-2 KIT (240 TESTS)
– B-BETACORONAVIRUS (B-β<COV)
– SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2
The RespiBio® Sars-CoV-2 Kit is a screen and confirmation Real-Time
PCR test for the qualitative detection of nucleic acid for: SARS-CoV-2
(RdRp gene) and B-βCoV (E & N genes) from RNA extracts.
The assay is lyophilised and ready to use with an in-built internal control
to monitor for PCR inhibition, as well as a positive control. Storage is at 2-8⁰C
and has no requirement for shipping on dry ice.
SARS-CoV-2 Assay vs Comparator PCR
Performance evaluation of the RespiBio® SARS-CoV-2 assay was carried
out using RNA extracts (fresh and archived) from respiratory specimens submitted to clinical laboratories as part of routine investigation of SARS-CoV-2.
The performance of the assay was compared to a commercial PCR assay
targeting Betacoronavirus E gene and SARS-CoV-2 S gene sequences.
– 312 (N)
– 99% (Positive Agreement)
– 92.4% (Negative Agreement)
1 | Suspended Sample
A swab is lightly coated with the stool/faecal sample, the swab is resuspended into a tube of SPS (Stool Preparation Solution).
2 | HEAT TREATED AND RELEASE DNA
The samples are heated on the EntericBio heat station at 103°C for 30 minutes.
3 | AUTOMATED TRANSFER OF SAMPLE INTO PCR WELL
The heat treated samples are placed on the EntericBio workstation for fully automated transfer of the processed samples directly to the lyophilised reaction wells using the EntericBio programme.
4 | AUTOMATED PATHOGEN DETECTION
The wells are capped and transferred to realtime PCR instrument for automated amplification, detection and analysis with the EntericBio programme.
Serosep have the following ISO certification:
ISO 13485 : 2016 awarded 4th December, 2007
ISO 9001 : 2015 awarded 13th October, 2003
EntericBio realtime faecal / stool pathogen detection kit is registered and carries the CE IVD mark.
Serosep’s EntericBio Dx Molecular GI Panel is cleared by the FDA.
Certs of Analysis
WEEE Recycling Policy
WEEE (Waste Electrical and Electronic Equipment) is anything that has a plug or a battery and is at the end of its useful life.
The recycling of WEEE is now a legal requirement. In Ireland all electric and electronic waste must be disposed of in accordance with the Irish WEEE Regulations and the EU Waste Electrical and Electronic Equipment Directive 2012.
Serosep Ltd are fully compliant with all WEEE regulations, please contact our service department for further information.
Serosep Ltd. offer customer support to all customers worldwide. Serosep, understands how important it is to have this support in place and having a highly skilled team allows us to provide this service. Each member of the Serosep technical support team is available and trained to answer any questions a customer may have.
Serosep prides itself on its highly qualified and experienced staff. All staff members are trained to a high level and the ethos of the company is to conduct business in a professional manner that is Friendly, Honest, Courteous and Helpful.
Further to this Serosep has adopted a policy of continuous investment in education and training of its staff members ensuring each member is at the cutting edge of technology. Our valued team of Clinical Scientists and support staff are continuously working to improve our products and services.
Serosep Ltd takes great pride in the service support and assistance we provide to customers. EntericBio has a dedicated technical and engineering support team both in the field and office based, ensuring availability at all times for the customer.
Scheduled maintenance is carried out on all equipment provided by Serosep in each sector of the business with the option of service contracts available to all customers. A prompt response to all breakdown calls, with a dedicated service team available to effectively deal with any issues that may arise.
Serosep has a designated team of application specialists that are available to cover all stages of the implementation process. This is inclusive of Installation, Validation, Transition of traditional methods to PCR and training. All application specialists are highly skilled molecular scientists.
A dedicated Technical support team for EntericBio provides 7 days a week support with an emergency number available for out of office hours. All technical support staff are qualified scientists with a wealth of knowledge and experience.
In this section all Material Satefy Data Sheets (MSDS), product information, product data, pack inserts and clinical data is available.
Frequently Asked Questions
Do samples have to be run in batches?
No they do not, however a positive and negative control must be used with each run.
What is the minimum and maximum throughput per run?
Minimum number of samples is 1 and maximum number is 46.
What controls are processed with each assay run on the system?
A positive and negative control is to be used with each run. An internal amplification control is included with each test.
How long does the process take?
Results are available within 3hrs on a full run of 46 samples.
Do we require a separate extraction system?
Can the same processed sample tube be used with all of the Entericbio assays?
What specimen types can be processed?
Faecal/Stool samples may be processed.
What storage conditions are required for the kit?
2˚c – 8˚c.
Can I run other non- Entericbio assays on the system?
The cycler is an open system and can be set up for use with other systems.
Does the system require specialised molecular laboratory facilities?
No, however we do recommend separation of the pre and post PCR testing areas and adherence to good laboratory practice for performing molecular assays.
Can the system be interfaced to the Laboratory IT system (LIMS)?
Yes, Serosep Ltd will provide full support.
Are qualified molecular scientists required to operate the system?
No, full training is provided.
What target panels are available on the system?
Please click our Panels Section to see all our available panels.