suPARnostic® TurbiLatex now CE/IVD approved for the Abbott Architect Chemical Diagnostic instruments

Sat Jun 13 2020

ViroGates announces that it has completed the development and regulatory approval (CE-IVD) of its suPARnostic® TurbiLatex product for the for the Abbott Architect 4000, 8000 and 16000 platform, which allows for clinical use of suPARnostic® TurbiLatex on the Abbott Architect instruments.

This is ViroGates’ first validation of the suPARnostic® TurbiLatex product on an Abbott instrument line. Abbott Laboratories is a global medical technology company with a diagnostics division, that has a turnover of 7.7 billion USD.

The Abbott system can run up to 1,800 blood samples per hour and work as a fully automated system, requiring no manual handling from the blood sampling until results are processed.

The approval of suPARnostic® TurbiLatex for the Architect platform complements the previous approvals for the Roche Diagnostics cobas systems and the Siemens ADVIA XPT system. Thus the suPARnostic® TurbiLatex can now be used at the top three biochemical instrument providers’ platforms.
The validation was done in collaboration with the French hospital, Hospices Civils de Lyon.

CEO Jakob Knudsen, says in a comment:”We are excited to offer suPARnostic® TurbiLatex for the Abbott Architect platform that serves many hospitals in Europe. Several hospitals have already enquired about this validation for clinical use in markets such as France, Spain and Italy. We look forward to implement suPARnostic® TurbiLatex at these hospitals to support faster and better patient triage decisions to the benefit of patients, hospitals, and payers.”

About the turbidimetric measurement principle: The suPARnostic® TurbiLatex product is based on a technology called turbidimetry that measures the loss of intensity of transmitted light in the blood sample being analysed. The principle of measuring blood samples by using turbidimetry is the basis of almost all central laboratory clinical chemistry platforms in hospitals.


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