Infinicyt™ CE-IVD
Last update: June 9th, 2022
At Cytognos we are continuously working to provide better solutions to improve patient care and enhance the efficiency of processes at the flow cytometry laboratory. In line with these objectives, we have released a new version of our software, Infinicyt™ 2.0.6 CE-IVD version, CE marked to the European In Vitro Diagnostic Medical Device Directive 98/79/EC.
In this new version, both the automated analysis using EuroFlow™ Databases and the manual analysis for diagnosis of oncohematological diseases and primary immunodeficiencies and evaluation of the immune system are CE-IVD. Thus, we help clinical laboratories to comply with EN ISO 15189 standard (“Medical laboratories – Requirements for quality and competence”) accreditation requirements.
Which functionalities are CE-IVD?
1. Automated analysis using Automated Gating & Identification (AG&I) tool for the following EuroFlow™ Databases:
- LST Database: for the screening of chronic lymphoproliferative disorders.
- ALOT Databases: for the evaluation of samples with suspicion of acute leukemia.
- BCP-ALL MRD Database: for B-cell precursor acute lymphoblastic leukemia MRD assessment.
- MM MRD Database: for MRD evaluation in multiple myeloma patients.
- PIDOT Database: for the evaluation of samples with suspicion of primary immunodeficiencies.
2. Compass Classification tool using the EuroFlow™ ALOT Classification Database.
3. Batch analysis tool to compare several files with the EuroFow™ Databases at the same time.
4. Manual analysis for diagnosis of oncohematological diseases and for the screening of suspected primary immunodeficiencies using the following EuroFlow™ panels and SOPs:
| Regulatory Status | Panel | Sample | Performance evaluation* | AG&I | COMPASS | Manual Analysis** |
|---|---|---|---|---|---|---|
 |
LST | PB | ||||
|
ALOT | PB & BM | ||||
|
BCP-ALL MRD | BM | ||||
|
MM MRD | BM | ||||
|
PIDOT | PB |
PB: Peripheral Blood; BM: Bone Marrow.
* Detailed information about performance evaluation included in the document: Instructions For Use (IFU) (see below).
** CE-IVD functionalities in manual analysis:
- Population tree
- Functions
- Statistics
- Diagrams
- APS
- Reference Image
- Analysis strategy
- Report
- Profile
- File Merge tool
Why use Infinicyt™ CE-IVD Edition?
- Accomplish regulatory requirements in clinical laboratories: IVDD
- Help with Lab Accreditation (ISO 15189) or other national accreditation programs:
- CE-IVD: CE marked in compliance with the European In Vitro Diagnostic Medical Device Directive 98/79/EC
- CE-IVD declaration of conformity
- Logging and security features
- User access control
- Audit Trail
- Password-protected files
- Electronic signatures
What documentation is available?
You can find additional information about this version and the CE-IVD validation below:
How can I download the new version?
Free download for Infinicyt™ 2.0 users
All Infinicyt™ 2.0 users can go to the Users Area, click on Download 2.0.6 version and select the CE-IVD or the RUO version.
Users of previous Infinicyt™ version or new users
These users can access to this version through an update or purchase. Get a quote for Infinicyt™ here or contact your Cytognos Sales Representative to get an offer.
Would you like to know more about this version or have a chat with one of our specialists? Get in touch with us.
