CE/IVD Approval Granted for suPARnostic® TurbiLatex on Abbott Architect Diagnostics

Sat Jun 13 2020

ViroGates has successfully completed development and received CE-IVD regulatory approval for its suPARnostic® TurbiLatex product for use on the Abbott Architect 4000, 8000, and 16000 platforms. This approval enables clinical use of suPARnostic® TurbiLatex on Abbott Architect instruments, marking ViroGates’ first validation of the product on an Abbott instrument line. Abbott Laboratories, a leading global medical technology company with a diagnostics division, reports a turnover of 7.7 billion USD.

The Abbott system, capable of processing up to 1,800 blood samples per hour, operates fully automatically without the need for manual intervention from blood sampling to result processing.

suPARnostic® TurbiLatex’s approval for the Architect platform adds to its existing validations for the Roche Diagnostics cobas systems and the Siemens ADVIA XPT system, enabling its use across the top three biochemical instrument providers’ platforms. The validation process took place in collaboration with Hospices Civils de Lyon, a French hospital.


Jakob Knudsen, CEO of ViroGates, expressed his excitement about making suPARnostic® TurbiLatex available for the Abbott Architect platform, which is widely used in European hospitals. With several hospitals in France, Spain, and Italy already inquiring about this validation for clinical use, ViroGates anticipates implementing suPARnostic® TurbiLatex in these institutions to enhance patient triage decisions, benefiting patients, hospitals, and payers alike.

Regarding the turbidimetric measurement principle: suPARnostic® TurbiLatex utilizes turbidimetry technology. This method measures the decrease in light intensity as it passes through a blood sample, a foundational principle for nearly all central laboratory clinical chemistry platforms in hospitals.


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