Method for analyzing blood coagulation characteristics of blood specimen

Patent metadata

Field	Value
Publication number	US-12313638-B2
Application number	US-202017427000-A
Country	US
Kind code	B2
Filing date	Jan 31, 2020
Priority date	Jan 31, 2019
Publication date	May 27, 2025
Grant date	May 27, 2025

Abstract

To provide a method for analyzing coagulation characteristics of a blood specimen. To provide a method for analyzing a blood specimen, including: acquiring a waveform related to a coagulation rate or coagulation acceleration of a sample obtained by mixing a subject blood specimen with a reagent for measuring coagulation time; extracting multiple parameters characterizing the waveform related to a coagulation rate or a coagulation acceleration; and determining an activity level or activity abnormality of a coagulation factor in the subject blood specimen on the basis of the multiple parameters.

First claim

The invention claimed is:

1. A method for analyzing a blood specimen, comprising:
acquiring a waveform related to a coagulation rate or a coagulation acceleration of a sample obtained by mixing a subject blood specimen with a reagent for measuring a coagulation time;
extracting a plurality of parameters characterizing the waveform related to the coagulation rate or the coagulation acceleration, the plurality of parameters including a plurality of coagulation rate parameters characterizing a plurality of calculation target areas of the waveform related to the coagulation rate, a plurality of coagulation acceleration parameters characterizing a plurality of calculation target areas of the waveform related to the coagulation acceleration, or a combination of the plurality of coagulation rate parameters and the plurality of coagulation acceleration parameters;
determining an activity level or activity abnormality of a coagulation factor in the subject blood specimen on the basis of the plurality of parameters; and
applying a treatment to a patient according to the activity level or activity abnormality of the coagulation factor, wherein
the plurality of parameters comprise one or more selected from the group consisting of:
a weighted average time vT, a weighted average height vH, a peak width vB, and a weighted average peak width vW, a B flattening vAB for the weighted average height, a W flattening vAW for the weighted average height, a B time rate vTB for the weighted average time, a W time rate vTW for the weighted average time, an average time vTa, an average height vHa, a B flattening vABa for the average height, a W flattening vAWa for the average height, an area start point time vTs, an area end point time vTe, an area median time vTm, an area time width vTr, a main peak start point time vNs, a main peak end point time vNe, and a main peak width vN for the plurality of calculation target areas of the waveform related to the coagulation rate;
a weighted average time pT, a weighted average height pH, a peak width pB, and a weighted average peak width pW, a B flattening pAB for the weighted average height, a W flattening pAW for the weighted average height, a B time rate pTB for the weighted average time, a W time rate pTW for the weighted average time, a main peak start point time pNs, a main peak end point time pNe, and a main peak width pN for a plurality of calculation target areas of a plus peak of the waveform related to the coagulation acceleration; and
a weighted average time mT, a weighted average height mH, a peak width mB, and a weighted average peak width mW, a B flattening mAB for the weighted average height, a W flattening mAW for the weighted average height, a B time rate mTB for the weighted average time, a W time rate mTW for the weighted average time, a main peak start point time mNs, a main peak end point time mNe, and a main peak width mN for a plurality of calculation target areas of a minus peak of the waveform related to the coagulation acceleration.

2. The analysis method according to claim 1 wherein
when the waveform related to the coagulation rate is defined as F(t) (t represents time) and each of t1 and t2 is defined as a time when F(t) is a predetermined value x (t1<t2), the calculation target area is an area satisfying F(t)≥x, and the vT and vH are represented by the following formulas, respectively:

v
⁢
T

=

M

∑

i
=

t
⁢
1

ι
⁢
2

⁢

F
⁡

(
i
)

(
3
)

vH
=

M

∑

i
=

t
⁢

⁢
1

t
⁢

⁢
2

⁢
i

(
4
)

wherein
M=Σ i=t1 t2 ( i×F ( i ))  (2)

the vTa, vHa, and vTm are represented by the following formulas, respectively, when F(t), t1, and t2 are defined as described above and the number of data points from F(t1) to F(t2) is n:

vTa
=

∑

i
=

ι
⁢

⁢
1

t
⁢

⁢
2

⁢
i

n

(
5
)

vHa
=

∑

i
=

Assignees

• Sekisui Medical Co Ltd
• Public Univ Corporation Nara Medical Univ

Inventors

• Kawabe Toshiki
• Oda Yukio
• Shima Midori
• Nogami Keiji
• Ogiwara Kenichi

Classifications

• G01N21/47

  Scattering, i.e. diffuse reflection (G01N21/25, G01N21/41 take precedence {G01N21/55 takes precedence}) · CPC title

• G01N33/86 Primary

  involving blood coagulating time {or factors, or their receptors} · CPC title

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G01N33/4905 Primary

  Determining clotting time of blood (by chemical methods G01N33/86, C12Q1/56) · CPC title