Automatic analysis device and analysis method

• US 10,295,555 B2
• Filed: 12/08/2014
• Issued: 05/21/2019
• Est. Priority Date: 12/25/2013
• Status: Active Grant

• Current Assignee: Hitachi High-Tech Company Limited (Hitachi, Ltd.)
• Original Assignee: Hitachi High-Technologies Corporation (Hitachi, Ltd.)
• Inventors: Yabutani, Chie, Makino, Akihisa, Matsubara, Shigeki
• Primary Examiner(s): Whatley, Benjamin R
• Application Number:
  US15/032,781
• Publication Number:
  US 20160274133A1
• Time in Patent Office: 1,625 Days
• Field of Search: None
• CPC Class Codes: G01N 2035/00702 Curve-fitting; Parameter matching; Calibration constants
• CPC Class Codes: G01N 2035/00821 nature of coded information
• CPC Class Codes: G01N 2035/00891 Displaying information to the operator
• CPC Class Codes: G01N 2035/009 alarms, e.g. audible
• CPC Class Codes: G01N 2035/0091 GUI [graphical user interfaces]
• CPC Class Codes: G01N 2035/0097 monitoring reactions as a function of time
• CPC Class Codes: G01N 2035/0441 for samples
• CPC Class Codes: G01N 2035/0443 for reagents
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01N 35/00584 Control arrangements for automatic analysers
• CPC Class Codes: G01N 35/00693 Calibration
• CPC Class Codes: G01N 35/00722 Communications; Identification
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/10 Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices G01N35/0099 takes precedence
• CPC Class Codes: G01N 35/1065 Multiple transfer devices

Abstract

A signal reference value (SLocal) is set at which a blood coagulation reaction time (T) of a blood coagulation time reference sample measured on the basis of the result of comparing a signal value (amount of transmitted light, amount of scattered light, amount of fluorescence, or turbidity) pertaining to blood coagulation time that varies temporally according to the mixing and reaction of the blood coagulation time reference sample and a reagent and a signal reference value (S) corresponds to an expected value (Te) for the blood coagulation reaction time that has been set beforehand so as to correspond to the blood coagulation time reference sample. As a result, it is possible to use the blood coagulation time reference sample to determine the state of the reagent and enhance the reliability of measurement results by setting a unique signal reference value for each reagent container.

Claims

1. An automatic analysis device, comprising:

a sample vessel placing section in which a first sample vessel containing a biological sample to be analyzed and a second sample vessel containing a blood clot time reference sample that has a known blood clot time are placed;

a reagent vessel placing section in which a plurality of reagent vessels each containing a reagent and each having a barcode attached thereto are placed;

a reaction vessel;

a sample dispensing mechanism which dispenses the biological sample or the blood clot time reference sample into the reaction vessel;

a reagent dispensing mechanism which dispenses the reagent into the reaction vessel from the reagent vessel;

a detector which detects a signal value that changes over time in accordance with a mixing reaction of the reagent and the biological sample or the blood clot time reference sample;

a barcode reader;

a control section programmed to;

control the barcode reader to read information from a barcode on a first reagent vessel of the plurality of reagent vessels,

obtain an expected blood clot time based on the information read from the barcode,

control the detector to detect first signal values from a mixture of the blood clot time reference sample and the reagent and generate a first reaction curve based on the first signal values,

determine a signal reference value based on the first reaction curve and the expected blood clot time,

store the signal reference value in association with identification information of the reagent,

control the detector to detect second signal values from a mixture of the biological sample and the reagent and generate a second reaction curve based on the second signal values,

determine whether the expected value of blood clotting time is in a predetermined range,

upon determining the blood clotting time is not in the range, issue an alarm on a display, and

determine the blood clotting time of the biological sample based on the signal reference value and the second reaction curve of the biological sample.

2. The automatic analysis device according to claim 1, wherein the one or more first signal values and the one or more second signal values indicate any one of transmitted light, an amount of scattered light, an amount of fluorescence, and a turbidity.

3. The automatic analysis device according to claim 1,

wherein the control section is programmed to display a status of the signal reference value for each of a plurality of reagents, including the reagent, on the display, and display an alarm upon determining a signal reference value has not been set for any of the plurality of reagents,

wherein the status indicates at least whether a corresponding signal reference value has been set for each of the reagents.

4. The automatic analysis device according to claim 1, wherein

the control section is programmed to determine another signal reference value based on a third reaction curve generated based on controlling the detector to detect third signal values from a mixture of another blood clot time reference sample and the reagent,

determine an approximate formula based on the signal reference value and the another signal reference value, and determine a third signal reference value based on the determined approximate formula, and

determine the blood clotting time of the biological sample based on the third signal reference value.

5. The automatic analysis device according to claim 4, wherein the approximate formula is formed by any one method of linear approximation, polynomial approximation, logarithmic approximation, and exponential approximation.

6. A sample analysis method using an automatic analysis device which includes:

a sample vessel placing section in which a first sample vessel containing a biological sample to be analyzed and a second sample vessel containing a blood clot time reference sample that has a known blood clot time are placed;

a reagent vessel placing section in which a plurality of reagent vessels each containing a reagent and each having a barcode attached thereto are placed;

a reaction vessel;

a sample dispensing mechanism which dispenses the biological sample or the blood clot time reference sample into the reaction vessel;

a reagent dispensing mechanism which dispenses the reagent of the into the reaction vessel from the reagent vessel;

a detector which detects a signal value that changes over time in accordance with a mixing reaction of the reagent and the biological sample or the blood clot time reference sample; and

a barcode reader; and

a control section, the method comprising steps executed by the control section of;

controlling the barcode reader to read information from a barcode on a first reagent vessel of the plurality of reagent vessels;

obtaining an expected blood clot time based on the information read from the barcode;

controlling the detector to detect first signal values from a mixture of the blood clot time reference sample and the reagent and generate a first reaction curve based on the first signal values;

determining a signal reference value based on the first reaction curve and the expected blood clot time;

storing the signal reference value in association with identification information of the reagent; and

controlling the detector to detect second signal values from a mixture of the biological sample and the reagent and generate a second reaction curve based on the second signal values;

determining whether the expected value of blood clotting time is in a predetermined range;

upon determining the blood clotting time is not in the range, issue an alarm on a display; and

determining the blood clotting time of the biological sample based on the signal reference value and the second reaction curve of the biological sample.