Dideco S.p.a.

Sorin Group Italia S.r.l.

Raffaele Castelli

Giuseppe Caputo

Leopoldo Della Ciana

Arnaldo Giannetti

Elena Comoglio

A device for determining the concentration of heparin in a fluid sample comprising: a container for holding the fluid sample; a container for holding the dye solution; a mixer for mixing the fluid sample and the dye solution; an illumination source for illuminating a mixture comprising the fluid sample and the dye solution with electromagnetic radiation having a substantially continuous range of wavelengths in the visible range; a detector for detecting the absorption spectrum of the mixture within the substantially continuous range of wavelengths; a recorder for recording the absorption spectrum of the mixture within the substantially continuous range of wavelengths; and a calculator for calculating a spectral parameter.

Method and device for determining the concentration of heparin in a sample of fluid

A method for determining the concentration of heparin in a fluid sample comprising: (a) providing a fluid sample containing heparin; (b) adding to the fluid sample a solution of a dye to form a mixture of sample and dye, wherein the dye interacts with the heparin in the sample so that the absorption spectrum of the mixture of sample and dye in the visible range varies as a result of the interaction in a manner quantitatively dependent on the heparin concentration; (c) determining the absorption spectrum in the visible range of the mixture of sample and dye; and (d) calculating a spectral parameter representative of both the reduction in the absorption of the free dye in solution and the increase in the absorption of the dye-heparin complex, the value of the spectral parameter being indicative of the concentration of heparin present in the fluid sample, in order to determine the concentration of heparin present in the fluid sample. The relationship between the value of the spectral parameter and the concentration of the heparin present in the fluid sample has been previously determined by determining the absorption spectra, in the visible range, of a composition comprising the fluid and the dye, in the absence of heparin and in the presence of a plurality of concentrations of heparin, and calculating the relationship between the value of the spectral parameter and the concentration of heparin. A device for performing this method is also provided.

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Mirandola, Italy

Raffaele Castelli