- How many samples can be processed with the EntericBio realtime system per run? +
- EntericBio realtime system allows the laboratory to process up to 46 faecal samples in one run. Our PCR reagents are designed so that the batch size is flexible and can be adjusted to suit laboratory throughput requirements and workflow.
- What controls are processed with each assay run on the system? +
- A positive and negative control is provided with each EntericBio realtime kit. They are processed with each batch of samples to monitor the performance of the assay. Additionally, internal amplification control is included in each test to monitor for sample inhibition.
Additional controls can be incorporated depending on laboratory quality control program and local requirements.
- What is the turnaround time for an EntericBio realtime assay? +
- EntericBio realtime assay bring samples to results in about 3 hours, for a full run of 46 samples. Most of the testing process is automated with a minimal staff hands-on time required.
- Is a separate extraction system required for EntericBio realtime assays? +
- No. All our assays are uniquely designed to work without a need for formal DNA/RNA extraction from faeces samples. This allows to reduce the cost and processing time required for samples. Samples are inoculated into EntericBio Stool Preparation Solution and heated before PCR set-up.
- Can the same EntericBio Stool Preparation Solution tube be used with multiple EntericBio assays? +
- Yes, once processed EntericBio Stool Preparation Solution tube can be used with multiple EntericBio realtime assays. This allows to reduce the hands-on and turnaround time for processing patients stool samples.
- What storage conditions are required for the EntericBio realtime kits? +
- EntericBio realtime kits can be stored at 2˚c - 8˚c.
- Can assay other than EntericBio realtime be run on the system? +
- The real-time PCR cycler is an open-system and can be used to run other in-house or commercial assays to help expand laboratory molecular testing and address emerging testing needs.
- Does the EntericBio system require specialised molecular laboratory facilities? +
- No. The system is designed to fit in routine microbiology laboratories and does not require specialised facilities. However, we do recommend separation of the sample preparation and PCR areas in accordance with Good Laboratory practice for performing molecular assays and relevant accreditation requirements.
EntericBio instrumention is bench-top with a small footprint and space requirement.
- Can the system be interfaced to the Laboratory Information Management System (LIMS)? +
- Yes. EntericBio realtime results can be directly interfaced with LIMS to streamline the reporting process. Our Technical Support team provides customers with all the necessary information required to link the EntericBio system to your LIMS.
- Are qualified molecular scientists / biomedical scientists required to operate the system? +
- No. EntericBio realtime assays have been designed to fit into routine microbiology laboratories. Thanks to simplicity and ease of use, EntericBio realtime assays can be set up by laboratory support workers/ laboratory assistants without any previous molecular experience with qualified biomedical scientists responsible only for the interpretation of the results. Full on-site training is provided by our Application Specialist team.
- Does Serosep provide technical support for the EntericBio realtime assays? +
- Serosep provides full, on-site training and continous support for laboratories interested in evaluating our products. Our Application Specialists will help to develop a comprehensive study plan and train the laboratory staff to carry out product evaluation / verification to required laboratory standards.
- What test panels are currently available on the EntericBio realtime system? +
- 1. GP1 – Campylobacter, Salmonella, Shigella, VTEC 1 and VTEC 2
2. GP2 - Campylobacter, Salmonella, Shigella, VTEC 1, VTEC 2, Cryptosporidium, Giardia
3. Clostridium difficile
- Will culture bacteria be still required when EntericBio realtime assays are used routinely? +
- Our PCR assays have excellent sensitivity and negative predictive value and allow rapid detection of most common bacterial and parasitic agents of gastroenteritis.
Positive results obtained with the EntericBio assays may require subsequent culture of bacterial agents for antibiotic sensitivity testing, identification, typing or epidemiological purposes, in accordance with local requirements and guidelines for specific bacterial pathogens.
- Do the EntericBio realtime tests have the CE mark for IVD? +
- All currently sold EntericBio realtime kits are fully CE-IVD marked and some are registered with other local regulatory authorities outside Europe. Please contact us for more detailed information about the availability of the EntericBio realtime tests in your country.
- How is the quality of EntericBio assays controlled? +
- Serosep is committed to deliver products and services conforming to our strict quality standards. All our products are manufactured in accordance with ISO standards 13485 and 9001.