We are the research center that provides services in the field of research:
evaluating the effectiveness of in vitro diagnostic medical devices on clinical samples.
The tests concern the verification whether the properties and operation of the in vitro diagnostic medical device, such as:
– rapid antigen tests for the detection of various pathogens,
– rapid antigen tests to detect antibodies from blood,
– NAT tests (Nucleic Acid Test) – molecular tests based on the detection of genetic material of pathogens in the collected material,
are compliant with the essential requirements, i.e. checking whether the operation of a given medical device meets the objectives assumed in its design.
During the tests of the product, the following are determined: diagnostic sensitivity and specificity, cross-reactions and interferences.
As part of the cooperation we provide:
– obtaining the opinion of the Bioethics Committee regarding the given project
– testing the product on clinical samples in accordance with the testing plan
– keeping reliable audit documentation
– preparation of a full study report.
– high qualifications and experience of the Principal Investigator and the medical staff involved in the research,
– experience in organizing collection points,
– a wide range of diagnostic tests for the detection and identification of pathogens,
– short research time,
– implemented quality management system based on ISO 9001:2015,
– conducting research in accordance with ethical principles, respect for human rights and dignity.
Ask for the offer: office@genXone.eu