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Monday, November 30, 2009

Evaluation of new USP Heparin Standard and NIBSC

HYPHEN BioMed evaluation :
A verification has been conducted using HYPHEN heparin assay kits (anti-IIa method, kit A221025) using the new USP vs the NIBSC UFH standard, and including HYPHEN UFH internal reference calibrators and quality controls, to verify homogeneous performance.

Reference Product IVD (510k) IVD (CE mark) RUO
A222301 Biophen UFH Calibrator x x
A223101 Biophen UFH Control x x
A221025 Biophen Heparin antiIIa (2 stages) x

Summary of results:


With the tested A221025 device, the measured values are in compliance with the expected values, and homogeneous between the new USP standard, the WHO/NIBSC standard for UFH, and internal reference standards and quality controls validated in HYPHEN.

Using A221025 kit, the measured values for the USP standard are measured in compliance with the expected values (theorical expected concentrations of the tested dilutions, from nominal concentration attributed as per USP method).

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