- BACTEROMIC
FAQ
What does the BACTEROMIC system include?
The BACTEROMIC system consists of 3 components (Filling Device , Analyzer, and Interpreter) and is used with BACTEROMIC Panel UNI 2.0 and accessory BACTEROMIC Syringe Plug.
What is the intended use of BACTEROMIC system?
BACTEROMIC Panel UNI 2.0 is intended to be used with the BACTEROMIC System as an aid for comprehensive assessment of bacterial susceptibility in patients with bacterial infection.
Is it possible to perform the test from the sample taken directly from the patient?
The test can be prepared from an isolated bacterial monoculture or positive blood culture*.
*the test from positive blood culture is in development.
Do you meet EUCAST and/or CLSI requirements?
The BACTEROMIC system complies with EUCAST requirements.
*CLSI requirements compliance is in development.
What is the results time?
The BACTEROMIC system generates a result in 16 hours for Panel UNI 2.0.
* The expected result time for panels Rapid UNI and BSI (in development ) is 6-8hours.
What number of panels can be tested parallel in the analyzer?
The maximum number of panels for simultaneous testing is 60. Panels can be added to the analyzer at any time (so-called “random access”).
Can the analyzer simultaneously test panels with different types of samples?
Yes, the analyzer can test different types of panels in parallel, including by the type of sample used.
Is it always necessary to add 10 panels (full rack) to the filling device / analyzer?
Panels can be added to the filling device or analyzer even individually, the only limitation of a single batch is the capacity of the rack – up to 10 panels. In addition, the system has so-called “random access” – panels can be placed at different numbers and intervals. This does not affect the process, as well as the time of the result of analyses conducted on previously added panels, until the maximum capacity of the analyzer – 60 panels – is reached.
Does BACTEROMIC offer separate panels for G+ and G- bacteria?
Thanks to the use of microfluidics, BACTEROMIC panels offer the largest information capacity on the market, allowing up to dozens of antibiotics to be placed and a patient sample to be tested regardless of the type of bacteria. Thus, it does not require creating separate products for G+ as well as G- bacteria, both types can be tested using one BACTEROMIC Panel.
What are the antibiotic concentration ranges and resistance mechanisms detected?
The antibiotic concentration ranges and detected resistance mechanisms are listed for each panel in the Instruction for Use.
How is the preparation of one panel, is the identification of microorganisms required before starting the test?
Identification of microorganisms is not required before starting the test. Identification should be performed according to the guidelines of the laboratory and entered into the BACTEROMIC system before the result is generated. Sampel preparation from bacterial isolates involves preparing an appropriate 0.5 McFarland suspension, followed by a single dilution in culture medium.
*Sample preparation for positive blood cultures ( panel BSI in development) involves a single dilution in medium.
Does the BACTEROMIC technology provide identification?
The BACTEROMIC system specializes in antimicrobial susceptibility testing.
Do you offer Mueller Hinton II Broth with the system? If not, are there any special requirements?
We offer Mueller Hinton II Broth vials.
What are the panel storing conditions?
The panel should be stored at 2-8 °C.
Can the BACTEROMIC equipment and software be integrated with a facility’s information system?
The BACTEROMIC system has the ability to connect to the facility’s information systems (Laboratory Information System – LIS).
How often is the BACTEROMIC system updated?
The system is updated annually, 3 months after new MIC breakpoints are announced.
Do you provide post market service?
Yes, the company provides post-market service under warranty.
How can I submit a data access request (EU Data Act)?
First point of contact:
Email: dataact@bacteromic.com
After we receive your email, we will send you a short request form to complete
Who can submit a data access request (EU Data Act)?
The User of a BACTEROMIC product (if authorised), or a third party designated by the User (with valid authorisation).