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Development of novel automated screening method for detection of FVIII inhibitors

A technology for inhibitors and coagulation agents, applied in the field of identification of coagulation inhibitors in patient samples, which can solve the problems of missing inhibitor tests and increased reporting errors in inhibitor assessment

Inactive Publication Date: 2018-06-08
PRESCIENT MEDICINE HLDG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Parallelism determination is currently a subjective assessment which leads to increased reporting errors and leads to potential omission of inhibitor assessments and potentially unnecessary inhibitor testing

Method used

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  • Development of novel automated screening method for detection of FVIII inhibitors
  • Development of novel automated screening method for detection of FVIII inhibitors
  • Development of novel automated screening method for detection of FVIII inhibitors

Examples

Experimental program
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Embodiment 1

[0044] As noted above, a typical Factor VIII assay determines Factor VIII activity (in percent) from a standard curve. The standard curve was generated by plotting the measured clotting time (in seconds) versus the known standard percent activity at several specific dilution points. Factor VIII activity in patient samples was then determined by mixing dilutions of patient plasma with equal amounts of known factor-deficient plasma, then plotting the clotting times observed for specific patient sample dilutions to obtain a standard curve, and from this standard The curve calculates whether the factor is present in the patient's plasma. To minimize the possibility of underreporting activity levels or missing the presence of inhibitors, when plotted logarithmically, the line given by the clotting time of the patient's plasma dilution should be parallel to that given by the systemic control plasma dilution. out the line.

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Abstract

Disclosed herein are methods for determining the presence of a coagulation inhibitor in a patient. A patient curve associated with the patient sample and having a patient slope (Ps) and a a standard curve associated with a control sample and having a control slope (Cs) are generated, and the Ps and the Cs are compared to obtain a Ps / Cs parallelism ratio. A Ps / Cs parallelism ratio of less than a predetermined ratio is indicative of presence of a coagulation inhibitor in the patient sample.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application No. 62 / 157,709, filed May 6, 2015. technical field [0003] The present disclosure relates generally to the field of blood coagulation, and more specifically to the identification of inhibitors of coagulation in patient samples. Background technique [0004] Factor VIII (FVIII) activity was determined by direct measurement of the activated partial thromboplastin time (APTT) of a patient plasma sample and by the semi-logarithmic scale of clotting time (in seconds) relative to that at several specific dilution points The standard known activity percentages were used to draw a standard curve, and the activity percentages were determined from this curve. The patient's plasma was then diluted by mixing it with an equal amount of plasma lacking the factor to be tested, and the factor VIII activity of the patient sample was measured, and the percentage of the ...

Claims

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Application Information

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IPC IPC(8): G01N33/49C12Q1/56G01N33/48G01N33/50G01N33/86
CPCG01N2333/755G01N2800/52G01N33/86A61P37/04A61P7/04
Inventor 马修·史蒂芬·埃文斯凯里·乔恩·唐纳森玛莉·伊莱恩·戴伊迈克尔·H·克里尔
Owner PRESCIENT MEDICINE HLDG INC
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