This invention provides a method that enables determining the fibrinogen concentration in plasma of a sample. The method comprises: computing the fibrinogen concentration in whole blood of the sample using magnetic particles; computing the waveform-based hematocrit value based on the peak value of the movement signal of the magnetic particles; subjecting the fibrinogen concentration in whole blood to hematocrit correction using the waveform-based hematocrit value; and computing the fibrinogen concentration in plasma of the sample.

An apparatus for in vitro testing of medical device thrombogenicity includes an enclosure; a heating element thermally coupled to the enclosure; and a temperature feedback circuit operably coupled to the heating element and configured to control the heating element to maintain an interior of the enclosure within a preset temperature range. Positive, negative, and intermediate control rods are provided as standards against which to compare a medical device test article. Multiple blood test loops can be established through the enclosure using a common blood supply. The medical device test article can be placed in one of the loops, while the remaining loops can contain controls. Blood can be circulated through the test loops at a flow rate similar to that encountered in vivo, and thrombus formation can be assessed thereafter.

An apparatus for in vitro testing of medical device thrombogenicity includes an enclosure; a heating element thermally coupled to the enclosure; and a temperature feedback circuit operably coupled to the heating element and configured to control the heating element to maintain an interior of the enclosure within a preset temperature range. Positive, negative, and intermediate control rods are provided as standards against which to compare a medical device test article. Multiple blood test loops can be established through the enclosure using a common blood supply. The medical device test article can be placed in one of the loops, while the remaining loops can contain controls. Blood can be circulated through the test loops at a flow rate similar to that encountered in vivo, and thrombus formation can be assessed thereafter.

The present invention provides a pipette tip, which can be used in in-vitro diagnostics, in particular in the diagnostic testing of body fluids, such as in coagulation testing. The Pipette tip contains two constituents in a spatially separated manner. The present invention furthermore provides a method of performing such diagnostics, e.g. coagulation analysis, and to the use of the pipette tip in such diagnostic testing.

The present invention provides a pipette tip, which can be used in in-vitro diagnostics, in particular in the diagnostic testing of body fluids, such as in coagulation testing. The Pipette tip contains two constituents in a spatially separated manner. The present invention furthermore provides a method of performing such diagnostics, e.g. coagulation analysis, and to the use of the pipette tip in such diagnostic testing.

Provided is a method for accurately measuring coagulation time of blood specimens showing various coagulation reactions. The method for measuring blood coagulation time includes acquiring coagulation reaction P(i) of a subject specimen and reaction velocity V(i); calculating a calculation start point Te by using the ratio of the V(i) to maximum reaction velocity as an index; and calculating time Tc giving P(Tc)=P(Te)×N % (0<N<100) and determining the Tc as the blood coagulation time.

Embodiments of a platelet testing system include an analyzer console device and a blood testing cartridge configured to releasably install into the console device. The cartridge device is configured with one or more measuring chambers and one or more mixing chambers that are fluidically connected within the cartridge device that enable the mixing of saline and a blood sample to a desired dilution. Additionally, the cartridge device is further configured with a cartridge slider that provides a reagent bead to the saline and blood mixture at a desired time. As such, one or more platelet activation assays can be conducted by measuring, through cartridge electrodes of the cartridge device, the detectable changes in platelet activity within the blood and saline mixture.

Embodiments of a platelet testing system include an analyzer console device and a blood testing cartridge configured to releasably install into the console device. The cartridge device is configured with one or more measuring chambers and one or more mixing chambers that are fluidically connected within the cartridge device that enable the mixing of saline and a blood sample to a desired dilution. Additionally, the cartridge device is further configured with a cartridge slider that provides a reagent bead to the saline and blood mixture at a desired time. As such, one or more platelet activation assays can be conducted by measuring, through cartridge electrodes of the cartridge device, the detectable changes in platelet activity within the blood and saline mixture.

Aspects of the present disclosure include a titration probe that mitigate the occurrences of titration probe clots. A bar such as segment of music wire, is extended across the tip of a titration probe and attached at both ends to the titration probe. The bar is configured to catch clots and prevent the clots from being collected along with a blood sample to be analyzed. The bar effectively reduces the cross sectional area of the titration probe tip.

Aspects of the present disclosure include a titration probe that mitigate the occurrences of titration probe clots. A bar such as segment of music wire, is extended across the tip of a titration probe and attached at both ends to the titration probe. The bar is configured to catch clots and prevent the clots from being collected along with a blood sample to be analyzed. The bar effectively reduces the cross sectional area of the titration probe tip.