A rapid, on-demand heparin-induced thrombocytopenia functional assay
A platelet and heparin technology, applied in measurement devices, biological tests, material testing products, etc., can solve the problems of limited performance of immunoassays, limited variability of assay performance, and large clinical and economic impacts.
Pending Publication Date: 2020-02-07
エモシス
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Problems solved by technology
This limitation translates into increased inter-laboratory variability in assay performance and a limited ability to compare results obtained by different laboratories, for example in the context of clinical research or clinical practice, e.g. when comparisons of the same patients obtained from different laboratories are required When the measurement result of
Therefore, results from different laboratories cannot be easily compiled without sophisticated statistical meta-analysis
[0018] In summary, the two main issues in HIT testing are the limited performance of immunoassays in terms of specificity, and the turnaround time along with the other aforementioned disadvantages of functional assays
These issues have raised concerns about overdiagnosis and overtreatment of HIT, which exposes a large number of thrombocytopenic patients to expensive alternative anticoagulants with an associated 10-20% risk of major bleeding, with potentially large clinical and economic implications
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[0103] Before explaining at least one embodiment in detail, it is to be understood that the subject matter is not limited in application to the details of construction and the arrangement of parts set forth in the following description. The subject matter is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
[0104] For clarity, non-essential elements have been omitted from some of the figures.
[0105]In contrast to prior art HIT assays, the HIT assays of the present subject matter can be performed on demand, even for one sample, whereas functional assays of the prior art, such as SRA and HIPA, are performed in batches. Additionally, the subject HIT assay provides results in a short time and can be performed in emergency situations. In contrast to the functional HIT assays of the prior a...
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A method for assaying a heparin-induced thrombocytopenia (HIT) in a patient's serum or plasma sample, the method comprising: incubating a mix of platelets with the patient's serum or plasma sample inthe presence of either a low concentration of heparin or a high concentration of heparin; incubating a mix of platelets in the presence or absence of a platelet activator; quantifying platelets and activated platelets in the mixes; calculating percentage of activated platelets within the platelets for each of the mixes; calculating a heparin platelet activation (HEPLA) index using the calculated percentages; measuring and calculating HEPLA indices of serum or plasma samples from donors not suffering from HIT; calculating cut-off values from the HEPLA indices of serum or plasma samples from donors not suffering from HIT, and determining whether a patient suffers of HIT or not by comparing the HEPLA index of the patient with the cut-off values.
Description
[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 478,105, filed March 29, 2017, the entire contents of which are incorporated herein by reference in their entirety. technical field [0003] This topic deals with diagnostic assays. More specifically, the subject matter relates to heparin-induced thrombocytopenia assays. Background technique [0004] Heparin-induced thrombocytopenia, also known as HIT, is a prothrombotic and potentially fatal iatrogenic disease that occurs in approximately 5-10% of patients exposed to heparin (Bell WR, T.P., 1976, Thrombocytopeniaoccuring During the administration of heparin: A prospective study in 52 patients, Annals of Internal Medicine, 155-160; King DJ, K.J., 1984, Heparin associated thrombocytopenia (heparin-related thrombocytopenia), Annals of Internal Medicine (Annals of Internal Medicine), 535; Dryjski M, D.H., 1996, Heparin induced thrombocytopeni...
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Login to View More IPC IPC(8): G01N33/68G01N33/86
CPCG01N33/6893G01N33/86G01N2800/222G01N33/96
Inventor F·奥卡福维F·乔治A·托马尔F·阿勒曼德
Owner エモシス