Microfluidic chip-based, universal coagulation assay

    公开(公告)号:US10534006B2

    公开(公告)日:2020-01-14

    申请号:US15909677

    申请日:2018-03-01

    摘要: A microfluidic, chip-based assay device has been developed for measuring physical properties of an analyte (particularly, whole blood or whole blood derivatives). The technologies can be applied to measure clotting times of whole blood or blood derivatives, determine the effects of anticoagulant drugs on the kinetics of clotting/coagulation, as well as evaluate the effect of anticoagulant reversal agents. These technologies can additionally be used to optimize the dosage of anticoagulation drugs and/or their reversal agents. The assay is independent of the presence of anticoagulant; clotting is activated by exposure of the blood sample in the device to a glass (or other negatively charged material such as oxidized silicon) surface, which activates the intrinsic pathway and can be further hastened by the application of shear flow across the activating materials surface. The absence of chemical activating agents and highly controlled and reproducible micro-environment yields a point of care universal clotting assay.

    CONTROLLED BLOOD DELIVERY TO MIXING CHAMBER OF A BLOOD TESTING CARTRIDGE

    公开(公告)号:US20200011884A1

    公开(公告)日:2020-01-09

    申请号:US16572567

    申请日:2019-09-16

    申请人: C A Casyso AG

    IPC分类号: G01N33/86 G01N1/38

    摘要: Embodiments of a blood coagulation testing system can operate as an automated thromboelastometry system that is particularly useful, for example, at a point-of-care site. In some embodiments, the blood coagulation testing system includes a single-use cartridge component configured to measure and mix reagents with blood received from a blood sample reservoir. A mixing chamber in the single-use cartridge includes different reagent beads that, when exposed to a pre-determined volume of blood, dissolve and mix specific reagents with the blood. The assembled blood cartridge further includes configurations that are designed to prevent blood from prematurely mixing with reagent beads in the mixing chamber and to guide blood flow in the mixing chamber to dissolve reagent beads in a desired order. Thus, the mixture obtained from the mixing chamber can be readily utilized to generate results for the blood coagulation testing system.

    METHODS OF DIAGNOSING MALIGNANT DISEASES
    55.
    发明申请

    公开(公告)号:US20190383815A1

    公开(公告)日:2019-12-19

    申请号:US16480342

    申请日:2018-01-25

    IPC分类号: G01N33/574 G01N33/86

    摘要: A method for diagnosing a malignant proliferative disease or disorder in a subject, and/or for following up, monitoring or prognosticating the therapy of a malignant proliferative disease or disorder in a subject is disclosed. The method is based on measurement of platelet-mediated fibrinogen-like protein 2 (FGL2) activity in a sample essentially comprising platelets obtained from the subject. In accordance with the disclosed method, platelet-mediated FGL2 activity level higher than control is indicative of the presence of a malignant proliferative disease or disorder in a subject.

    METHOD FOR DETERMINING CAUSE OF THE PROLONGATION OF BLOOD COAGULATION TIME

    公开(公告)号:US20190353674A1

    公开(公告)日:2019-11-21

    申请号:US16528871

    申请日:2019-08-01

    IPC分类号: G01N33/86

    摘要: Provided is a method of accurately and easily determining a cause of the prolongation of blood coagulation time.The method of determining a cause of the prolongation of blood coagulation time in test plasma includes (1) measuring the blood coagulation time of samples including (a) the test plasma only, (b) normal plasma only, and (c) the test plasma and the normal plasma mixed at least at a mixing ratio, (2) drawing a polygonal line graph by plotting the measurement results of the samples (a), (b) and (c), with the vertical axis representing the blood coagulation time or the prolongation ratio of blood coagulation time and the horizontal axis representing the mixing ratio or mixing proportion of the test plasma or the normal plasma, and thereby determining the area A under the polygonal line and the area B under a line segment that connects the plotted measurement results of the samples (a) and (b), (3) calculating the ratio of the area (A−B) obtained by subtracting the area B from the area A, with respect to the area B, ((A−B)/(B)): area ratio X), (4) performing the steps of (1) and (2) for a coagulation factor inhibitor-positive plasma, and thereby determining in advance a standard area ratio Y, and (5) comparing the area ratio X and the standard area ratio Y, and determining the test plasma as a coagulation factor inhibitor type in the case where Y≤X, or as a coagulation factor deficient type in the case where Y>X.

    Thrombogenicity Test Apparatus and Associated Methods

    公开(公告)号:US20190323059A1

    公开(公告)日:2019-10-24

    申请号:US16375413

    申请日:2019-04-04

    IPC分类号: C12Q1/56 A61L33/00 G01N33/86

    摘要: 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.

    CAP REMOVAL DEVICE AND THROMBELASTOGRAPHY DEVICE HAVING SAME

    公开(公告)号:US20190210856A1

    公开(公告)日:2019-07-11

    申请号:US16097556

    申请日:2017-05-02

    IPC分类号: B67B3/28 G01N33/86 G01N33/49

    摘要: A cap removal device and a thrombelastography device having same are disclosed. The cap removal device comprises a drive part (1), a connection shaft (2), and a cap removal member (3). The connection shaft (2) can move upward when driven by the drive part (1). The cap removal member (3) has an end (31) and the other end (32); the end (31) is pivotally connected to the connection shaft (2), so that when the connection shaft (2) moves upward when driven by the drive part (1), the cap removal member (3) rotates, due to the upward movement, around a pivot point (4) located between the end (31) and the other end (32) of the cap removal member (3), so that the other end (32) of the cap removal member (3) moves downward to contact a cap (5) to be removed, thereby removing the cap (5). The thrombelastography device has the cap removal device, and thus can achieve the automatic removal of the cap (5) and the automated control on the drive part (1), thereby improving the cap removal efficiency and the test efficiency, and saving time of manually removing the cap.