Bio- X Diagnostics’ mission is to design, manufacture and promote diagnostic test kits based on the following technological platforms:
For the Laboratory Range:
• ELISA (Enzyme Linked ImmunoSorbent Assay)
IFA (ImmunoFluorescence Assay)
RT-PCR (Real Time Polymerase Chain Reaction)
For Point of Care tests :
• Immunochromatography (Vertical Flow ImmunoAssay)
We integrate our know-how to the development and manufacturing of our tests
o Purification of native antigens
o Expression of recombinant proteins
• Monoclonal antibodies:
o Production exclusively in vitro.
o No use of mice (ascitic fluid puncture)
o Proprietary hybridomas bank
• Molecular biology:
o Determination / choices of sequences
o Protocols adapted to different types of specimen and validated accordingly
o High quality reagents that can be used on a variety of instruments.
• Validation :
o Specimen panel: performance of assay is measured based on large panels that are representative of the final application.
Validation methods: according to current standards for immunoenzymatic assays or PCR; Bayesian analysis can be used alternatively.
Standard GTA 27 (immunoenzymatic assays)
Standard U 47 600-2 (PCR)
o External validation by reference institutes for diseases listed by the World Organization for Animal Health (OIE)