ImmunoCyt™ / uCyt+™  Certification

DiagnoCure has implemented a certification process for the use of ImmunoCyt™/uCyt+™. The process, supervised by DiagnoCure or an authorized trainer, certifies that the laboratory has the necessary materials to run ImmunoCyt™/uCyt+™ and that its personnel is properly trained to interpret the ImmunoCyt™/uCyt+™ test.

4-step certification process

Installation qualification (IQ)

The installation qualification aims to ensure that the necessary equipment and material to run ImmunoCyt™/uCyt+™ are available and adequate.

Operation qualification (OQ)

The operation qualification evaluates the technical process, in particular the immunoreaction quality with control slides.

Performance qualification (PQ)

The performance qualification evaluates the technical procedure, in particular the cell recovery and microscopy reading of clinical material. Urine samples from the laboratory are processed with ImmunoCyt™/uCyt+™ and interpreted by the personnel trained. The certified trainer then verifies the slides and reading results, and can confirm that the test has been processed and interpreted adequately.

Certification

DiagnoCure Inc. issues a certificate stating the successful completion of the ImmunoCyt™/uCyt+™ qualification. The name of the certified laboratory is added to the list of Certified Laboratories.