Abstract: To reduce the complexity and risk associated with activated platelet transfusions, thrombocytopenic patients are transfused with exclusively non-activated platelets. A preferred embodiment is through routine screening of platelet units in the hospital blood bank using dynamic light scattering and selective allocation of platelets, with non-activated platelets being exclusively transfused to thrombocytopenic patients, especially patients with cancers such as hematologic malignancies. Activated platelets typically contain activated factors of the innate immune system called complement, transforming growth factor beta (TGF?), interleukin 6 (IL-6), CD40 ligand (CD40L) and C-reactive protein (CRP) for example. Some of these activated factors have already been shown to correlate with microparticles and others are expected to correlate: the higher the platelet activation the more microparticles and the higher the concentration of these factors.

Abstract: Dynamic light scattering (DLS)-based particle testing is used for screening to predict drug-induced complications with heparin and other compounds known to lead to thrombocytopenia in many patients. The measurement of particle content is used to both predict as well as confirm drug-induced thrombocytopenia (“DIT”).

Abstract: To reduce the complexity and risk associated with activated platelet transfusions, thrombocytopenic patients are transfused with exclusively non-activated platelets. A preferred embodiment is through routine screening of platelet units in the hospital blood bank using dynamic light scattering and selective allocation of platelets, with non-activated platelets being exclusively transfused to thrombocytopenic patients, especially patients with cancers such as hematologic malignancies. Activated platelets typically contain activated factors of the innate immune system called complement, transforming growth factor beta (TGF?), interleukin 6 (IL-6), CD40 ligand (CD40L) and C-reactive protein (CRP) for example. Some of these activated factors have already been shown to correlate with microparticles and others are expected to correlate: the higher the platelet activation the more microparticles and the higher the concentration of these factors.

Abstract: An apparatus for separating components of a body fluid, especially whole blood, to prepare a sample that may be analyzed using spectrophotometric techniques such as dynamic light scattering (DLS) to assess the composition of the sample are disclosed. A microfluidic separator may be defined by a capillary tube having red blood cell traps incorporated therein; importantly, the microfluidic separator does not activate platelets as the whole blood flows through the separator by air replacement action (i.e., suction). Whole blood is processed to remove red blood cells so that DLS may be used to analyze the separated sample to detect merosomes in the sample.

Abstract: Apparatus and methods for monitoring platelet quality are disclosed. A bag of platelet concentrate is oriented in a desired manner on a transparent surface that is illuminated from one side with a light source. A clamp applies pressure to a desired portion of the bag to temporarily manipulate a predetermined portion of the bag and therefore the fluid in the bag in a known and repeatable manner. A flow inducing member applies pressure to the bag to thereby cause a turbulent flow of the fluid from the bag through a flow path. A detector records optical characteristics of light diffracted by the flowing particles, which is analyzed by software to derive a score correlating to the quality of the platelets. Platelet swirl is scored as a measure of platelet quality where more resting, discoid platelets result in a higher score.

Abstract: The described apparatus for analyzing a biological sample includes a first analysis instrument fluidly connected to a reservoir for receiving a first flow of the biological fluid and adapted for performing a measurement of a property of the biological sample. A second analysis instrument is fluidly connected to the reservoir for receiving a second flow of the biological fluid and adapted for performing a thermally controlled analysis of the biological sample. The second analysis instrument includes a thermally controlled chamber. A flow stopping device stops the second flow within the thermally controlled chamber in order to allow the second analysis instrument to perform the thermally controlled analysis of the biological sample. The first analysis instrument may include, for example, a hematology analyzer or a flow cytometer, and the second analysis instrument may include, for example, a dynamic light scattering instrument.

Abstract: A deformable container (5) containing a fluid product to be tested includes a flexible outer wall (10) enclosing a main cavity (9) therein for holding the fluid product and at least one appendix (14) for containing a sample volume to be tested. The appendix is displaceable from a first position, wherein the appendix is invaginated within a periphery of the deformable container, and a second position, wherein the appendix protrudes outwardly from the outer wall and defines a second cavity (7) therein for a sample fluid volume, such as to permit testing of the sample volume within the appendix (14). The appendix is displaced into the second position by the fluid product within the deformable container when pressure is applied to the outer wall to force the sample volume of the fluid product from the main cavity of the deformable container into the second cavity of the appendix.

Abstract: Methods of detecting bacterial contamination in a platelet concentrate are performed using a dynamic light scattering (DLS) instrument and a sample holder. A sample of platelet concentrate can be held vertically or horizontally in a capillary in the sample holder. Alternatively, novel platelet storage bags modified to include an optically translucent window can be held within another variant of the sample holder. Still alternatively, platelet storage bags having one or more tubes detachably appended to the bag can be used. A sample is drawn off into an appended tube for placement directly into the sample holder. This method provides a number of related, non-invasive techniques for detecting whether bacteria has contaminated a platelet concentrate. Contamination indicators include a population of particles different from platelets, microparticles or proteins, bad-quality platelets, i.e. low DLS score, and very high or very low scattering intensity.

Abstract: Apparatus and methods for monitoring platelet quality are disclosed. A bag of platelet concentrate is oriented in a desired manner on a transparent surface that is illuminated from one side with a light source. A clamp applies pressure to a desired portion of the bag to temporarily manipulate a predetermined portion of the bag and therefore the fluid in the bag in a known and repeatable manner. A flow inducing member applies pressure to the bag to thereby cause a turbulent flow of the fluid from the bag through a flow path. A detector records optical characteristics of light diffracted by the flowing particles, which is analyzed by software to derive a score correlating to the quality of the platelets. Platelet swirl is scored as a measure of platelet quality where more resting, discoid platelets result in a higher score.

Abstract: A method of diagnosing a pathological condition by detecting microparticles in a sample of bodily fluid using dynamic light scattering (DLS) is disclosed. The detection of microparticles in the bodily fluid by DLS may be used as an indicator of existing disease, to evaluate a risk of disease, as well, as to monitor the efficacy of a treatment for disease.

Abstract: There is described a sample holder and associated fluid container assembly for optical analysis of a fluid sample within a translucent container of the fluid container assembly. The sample holder includes clamping members rotatably mounted to a frame for rotation, about parallel axes spaced apart from each other, between a container accepting position in which the clamping members are spaced apart from the translucent container, and an analysis position in the clamping members abut the translucent container. The clamping members each define an optical waveguide slot extending therethrough that is substantially aligned with the translucent container when the clamping members are disposed in the analysis position, to thereby provide optical access to the translucent container for optical analysis of the fluid sample therein.

Abstract: A deformable container (5) containing a fluid product to be tested includes a flexible outer wall (10) enclosing a main cavity (9) therein for holding the fluid product and at least one appendix (14) for containing a sample volume to be tested. The appendix is displaceable from a first position, wherein the appendix is invaginated within a periphery of the deformable container, and a second position, wherein the appendix protrudes outwardly from the outer wall and defines a second cavity (7) therein for a sample fluid volume, such as to permit testing of the sample volume within the appendix (14). The appendix is displaced into the second position by the fluid product within the deformable container when pressure is applied to the outer wall to force the sample volume of the fluid product from the main cavity of the deformable container into the second cavity of the appendix.

Abstract: A method of diagnosing a pathological condition by detecting microparticles in a sample of bodily fluid using dynamic light scattering (DLS) is disclosed. The detection of microparticles in the bodily fluid by DLS may be used as an indicator of existing disease, to evaluate a risk of disease, as well as to monitor the efficacy of a treatment for disease.

Abstract: The described apparatus for analyzing a biological sample includes a first analysis instrument fluidly connected to a reservoir for receiving a first flow of the biological fluid and adapted for performing a measurement of a property of the biological sample. A second analysis instrument is fluidly connected to the reservoir for receiving a second flow of the biological fluid and adapted for performing a thermally controlled analysis of the biological sample. The second analysis instrument includes a thermally controlled chamber. A flow stopping device stops the second flow within the thermally controlled chamber in order to allow the second analysis instrument to perform the thermally controlled analysis of the biological sample. The first analysis instrument may include, for example, a hematology analyzer or a flow cytometer, and the second analysis instrument may include, for example, a dynamic light scattering instrument.

Abstract: A method for storing and using platelets and an associated platelet structure. At least one modified platelet is formed. Each modified platelet includes a platelet and at least one polymerated chemical. Each polymerated chemical includes a polymer covalently bonded directly to the platelet or includes the polymer and a linker molecule such that the linker molecule is covalently bonded to the platelet and the polymer is covalently attached to the linker molecule. The polymer of each polymerated chemical of each modified platelet is polyethylene glycol (PEG) or a PEG derivative. Forming each modified platelet does not include modifying the platelet membrane of each platelet with a glycan-modifying agent. The at least one modified platelet is stored in a temperature range below 0° C. After being stored, the at least one modified platelet may be introduced into a subject to treat a condition related to a reduced platelet function.

Abstract: A method for preventing bacterial biofilm formation in a blood product, the method comprising modifying a blood product with a polymer selected from the group consisting of polyethylene glycol (PEG), PEG derivatives and mixtures thereof. Preventing bacterial biofilm formation in this way increases the planktonic to adherent ratio of any contaminating bacteria, and thereby facilitates detection of bacterial contamination.

Abstract: A method for storing and using platelets and an associated platelet structure. At least one modified platelet is formed. Each modified platelet includes a platelet and at least one polymerated chemical. Each polymerated chemical includes a polymer covalently bonded directly to the platelet or includes the polymer and a linker molecule such that the linker molecule is covalently bonded to the platelet and the polymer is covalently attached to the linker molecule. The polymer of each polymerated chemical of each modified platelet is polyethylene glycol (PEG) or a PEG derivative. Forming each modified platelet does not include modifying the platelet membrane of each platelet with a glycan-modifying agent. The at least one modified platelet is stored in a temperature range below 20° C. for at least one hour. After being stored, the at least one modified platelet may be introduced into a mammal.

Abstract: A method of diagnosing a pathological condition by detecting microparticles in a sample of bodily fluid using dynamic light scattering (DLS) is disclosed. The detection of microparticles in the bodily fluid by DLS may be used as an indicator of existing disease, to evaluate a risk of disease, as well as to monitor the efficacy of a treatment for disease.

Abstract: There is described a sample holder and associated fluid container assembly for optical analysis of a fluid sample within a translucent container of the fluid container assembly. The sample holder includes clamping members rotatably mounted to a frame for rotation, about parallel axes spaced apart from each other, between a container accepting position in which the clamping members are spaced apart from the translucent container, and an analysis position in the clamping members abut the translucent container. The clamping members each define an optical waveguide slot extending therethrough that is substantially aligned with the translucent container when the clamping members are disposed in the analysis position, to thereby provide optical access to the translucent container for optical analysis of the fluid sample therein.

Abstract: A sample holder holds various sizes of capillaries or cuvettes for use in dynamic light scattering (DLS) or quasi-elastic light scattering (QELS), such as in DLS of fluid samples such as platelet solutions, whole blood, colloids or the like. The sample holder has a base with a stationary backing member and a sliding, rail-mounted clamping member that is magnetically biased toward the backing member. The sample holder has Peltier-type thermoelectric heating/cooling elements that extend the full height of the clamping and backing members to optimize heat transfer efficiency. The sample holder further includes horizontal slots that enable collection of scattered light from various angles around the device. Finned heat sinks are mounted above and below the horizontal slots on the outwardly facing surfaces of the backing and clamping members to stabilize the temperature of the fluid sample in the sample holder without interfering with incident or scattered light.