IP Library Granted Patent US 12674809
Granted Patent B2
US 12674809 · App. 18/067,483 · Granted Jul 7, 2026

Specimen analysis method and specimen analyzer

Inventors: Naoya Kameyama (Kobe, JP); Tomoyuki Nishida (Kobe, JP); Yasuhiro Takeuchi (Kobe, JP); Takayuki Arai (Kobe, JP); Masahiro Mimura (Kobe, JP)
Assignee: SYSMEX CORPORATION
G01N35/0092G01N35/00732G01N35/00871G01N2035/00851G01N2035/00891
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Quick Facts
Patent No.
US 12674809
App. No.
18/067,483
Granted
Jul 7, 2026
Kind
B2
Abstract

Disclosed is a specimen analysis method for analyzing a specimen regarding a plurality of measurement items, the specimen analysis method comprising: measuring a first measurement item and a second measurement item on the basis of a measurement order; executing a process related to a time difference between a measurement of the first measurement item and a measurement of the second measurement item; and obtaining a calculation value from a measurement value of the first measurement item and a measurement value of the second measurement item.

Claims (29)

1 . An immunoassay analyzer configured to measure a target analyte in a specimen, comprising:

a measurement device configured to perform measurement on the specimen, the measurement device comprising:

a sample dispenser configured to dispense the specimen into a number of containers, wherein the number of containers is determined by a number of target analytes requested to measure by a measurement order issued for the specimen;

a reagent dispenser configured to dispense an aliquot of reagent into each of the containers to prepare measurement samples, wherein the reagent is prepared in different types that each contain a different labeled antibody bound to a specific target analyte in the measurement sample; and

a light detector configured to detect light excited out from the labeled antibody bound to the target analyte in each of the measurement samples; and

a controller programmed to control the measurement device to measure the target analytes in the measurement samples requested to measure by the measurement order and obtain measurement values on the measured target analytes based on amounts of lights detected by the light detector,

wherein the controller is programmed to control the measurement device to:

prepare a first measurement sample from one specimen to measure a first target analyte and a second measurement sample from said one specimen to measure a second target analyte in response to the measurement order requesting measurement of the first and second target analytes, wherein the first target analyte is a first type of protein, and the second target analyte is a second type of protein; and

perform a first measurement on the first measurement sample to obtain a first measurement value representative of an amount of the first type of protein in the first measurement sample and a second measurement on the second measurement sample to obtain a second measurement value representative of an amount of the second type of protein in the second measurement sample,

wherein the controller is programmed to perform the first measurement and perform the second measurement at a measurement interval after the first measurement is performed,

wherein the controller is programmed to calculate an arithmetic relationship between the first measurement value and the second measurement value,

wherein the controller is further programmed to set the measurement interval equal to or less than a predetermined time interval to suppress a decrease of reliability of a calculation result of the arithmetic relationship due to a temporal degrading of the first and second types of proteins, and wherein setting the measurement interval comprises at least one of (a) or (b):

(a) determining by the controller, before preparation of the first and second measurement samples, if it is possible to perform the first and second measurements at a time interval equal to or less than the predetermined time interval, and wherein the controller is programmed to execute the preparation of the first and second measurement samples in response to a determination that the time interval is equal to or less than the predetermined time interval; or

(b) determining by the controller, after performing the first and second measurements, if the second measurement has been performed within the predetermined time interval after the first measurement had been performed, and wherein the controller is programmed to execute the calculation of the arithmetic relationship between the first measurement value and the second measurement value in response to a determination that the second measurement has been performed within the predetermined time interval after the first measurement had been performed.

2 . The immunoassay analyzer of claim 1 , wherein setting the measurement interval further comprises prohibiting by the controller, before preparation of the first and second measurement samples, the preparation of the first and second measurement samples in response to a determination that the time interval is longer than the predetermined time interval.

3 . The immunoassay analyzer of claim 1 , wherein setting the measurement interval further comprises prohibiting by the controller, before preparation of the first and second measurement samples, the preparation of the first and second measurement samples in response to a determination that remaining amounts of reagents used, respectively, for the first and second measurements are less than threshold amounts enough to perform the first and second measurements, respectively.

4 . The immunoassay analyzer of claim 1 , wherein setting the measurement interval further comprises prohibiting by the controller, before preparation of the first and second measurement samples, the preparation of the first and second measurement samples in response to a determination that one of reagents used for the first and second measurements is past its expiration date.

5 . The immunoassay analyzer of claim 1 , wherein setting the measurement interval further comprises prohibiting by the controller, before preparation of the first and second measurement samples, the preparation of the first and second measurement samples in response to a determination that an environmental temperature in the measurement device is without a predetermined temperature range.

6 . The immunoassay analyzer of claim 1 , wherein the controller is programmed to generate a previously presented measurement order for the specimen to measure the first and second target analytes in response to a determination that the second measurement has been performed past the predetermined time interval after the first measurement had been performed.

7 . The immunoassay analyzer of claim 1 , wherein the controller is programmed to issue a notification that measurements of both first and second types of protein are not requested, in response to receipt of a measurement order that requests a measurement of only one of the first and second types of protein.

8 . The immunoassay analyzer of claim 1 , wherein the controller is programmed to control the measurement device to measure the first and second types of proteins in response to a determination that the measurement order requests measurements of both first and second types of proteins.

9 . The immunoassay analyzer of claim 1 , wherein

the controller is programmed to monitor an environmental temperature at the measurement device during the first and the second measurements,

the first type of protein includes amyloid beta 1-40 and the second type of protein includes amyloid beta 1-42, and

an allowable temperature range to perform the first measurement is narrower than an allowable temperature range to perform the second measurement.

10 . The immunoassay analyzer of claim 1 , wherein calculating the arithmetic relationship between the first and second measurement values comprises calculating a ratio between the first measurement value and the second measurement value.

11 . The immunoassay analyzer of claim 1 , wherein the first type of protein includes a first type of amyloid beta or amyloid beta precursor protein, and the second type of protein includes a second type of amyloid beta or amyloid beta precursor protein different from the first type.

12 . The immunoassay analyzer of claim 11 , wherein the first type of amyloid beta or amyloid beta precursor protein includes one of amyloid beta 1-40 and amyloid beta 1-42, and the second type of amyloid beta or amyloid beta precursor protein includes another one of the amyloid beta 1-40 and the amyloid beta 1-42.

13 . The immunoassay analyzer of claim 12 , wherein the first type of amyloid beta or amyloid beta precursor protein includes one of amyloid beta 1-42 and amyloid beta precursor protein 669 - 711 , and the second type of amyloid beta or amyloid beta precursor protein includes another one of the amyloid beta 1-42 and the amyloid beta precursor protein 669 - 711 .