Molecular
Microbiology
Solutions

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.

Process efficiency

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.

Equipment footprint

Small and modular footprint provides flexibility for placement in any lab.

Shelf life

All assays come with 24months stability and no requirement for frozen storage.

Support

Full IQ/OQ & PQ support with ongoing class leading real time technical support provided by our lab scientists to your lab scientists.

The Environment

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.

Equipment

EntericBio Heatstation

For heat treatment of EntericBio SPS tubes.

Width: 200mm
Height: 100mm
Lenght: 370mm

EntericBio Workstation

For automated EntericBio reaction set up.

Width: 650mm
Depth: 480mm
Height: 630mm
Weight: 45kg

Roche Lightcycler® 480

Amplification and detection of target organisms using EntericBio proprietary analysis software.

Width: 574mm
Depth: 588mm
Height: 497mm
Weight: 55kg

Applied Biosystems® 7500 Fast Real-Time PCR System

Amplification and detection of target organisms using EntericBio proprietary analysis software.

Width: 340mm
Depth: 450mm
Height: 490mm
Weight: 34kg

Ancillary Laboratory Items

Mixmate®

Width: 170mm
Depth: 230mm
Height: 130mm
Weight: 4.15kg

Eppendorf Centrifuge

Centrifugation of EntericBio reaction wells.

Width: 335mm
Depth: 415mm
Height: 250mm
Weight: 29kg

Kit Components

EntericBio realtime Test Kit

Test kit for 240 tests.
Assay Strips
Reconstitution Solution
Positive Control
Re-suspension Buffer

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
   (SARS-COV-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.

CEIVD
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.

RNA EXTRACTS
– 312 (N)
– 99% (Positive Agreement)
– 92.4% (Negative Agreement)

Testing Process

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.

Quality Assurance

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.

Support

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.

Customer Support

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.

Service Support

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.

Application Support

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.

Technical Support

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.

entericbiosupport@serosep.com | +353 87 3410733
support@serosep.co.uk | +44 (0) 129 388 9215

Downloads

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?

No.

Can the same processed sample tube be used with all of the Entericbio assays?

Yes.

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.

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