Clinical analyzer automated system fault diagnostic methods

Patent metadata

Field	Value
Publication number	US-12372544-B2
Application number	US-202117358366-A
Country	US
Kind code	B2
Filing date	Jun 25, 2021
Priority date	Dec 28, 2018
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

A method for operating and diagnosing faults in a laboratory instrument comprising a plurality of subsystems may comprise performing an analytic sequence and a set of diagnostic steps. Such a method may be performed using a diagnostic reagent comprising paramagnetic particles and lacking an antibody component. Such a method may also include evaluating a set of the instrument's subsystems in the opposite of the order in which those subsystems are used during analysis.

First claim

What is claimed is:

1. A method of operating and diagnosing faults in a laboratory instrument comprising a plurality of subsystems, the method comprising:
a) performing an analytic sequence of steps to analyze a biological sample, wherein the analytic sequence of steps utilizes a set of subsystems from the plurality of subsystems of the laboratory instrument in a first order; and
b) performing a set of diagnostic steps to identify faults in the laboratory instrument, wherein:
i) performing the set of diagnostic steps comprises evaluating each subsystem in the set of subsystems in a second order;
ii) the second order in which each subsystem in the set of subsystems is evaluated reverses the first order in which the set of subsystems are used in the analytic sequence of steps.

2. The method of claim 1 , wherein:
a) the set of subsystems comprises:
i) a sample dispensing subsystem; and
ii) a chemiluminescence detection subsystem;

b) the first order comprises using the sample dispensing subsystem to dispense a biological fluid into a reaction vessel before using the chemiluminescence detection subsystem to detect chemiluminescent light from the reaction vessel; and
c) the second order comprises evaluating operation of the chemiluminescence detection subsystem before evaluating operation of the sample dispensing subsystem.

3. The method of claim 2 , wherein:
a) evaluating the chemiluminescence detection subsystem comprises, for each of a set of one or more vessels, performing a set of substrate blank check steps comprising:
i) adding a substrate adapted to generate chemiluminescent light in reaction with ALP to that vessel;
ii) incubating that vessel after the substrate adapted to generate chemiluminescent light in reaction with ALP is added to that vessel; and
iii) using a luminometer comprised by the chemiluminescence detection subsystem, measuring chemiluminescent light from that vessel after it has been incubated and placed in a luminometer vessel chamber;
and

b) each vessel from the set of one or more vessels is empty when the substrate adapted to generate chemiluminescent light in reaction with ALP is added to it.

4. The method of claim 3 , wherein the method comprises:
a) determining that there is a fault in the laboratory instrument based on chemiluminescent light detected while performing the set of substrate blank check steps;
b) extending evaluation of the chemiluminescence detection subsystem by performing a set of no-vessel light check steps comprising:
i) measuring light detected in the luminometer vessel chamber by the luminometer when no vessel is present in the luminometer vessel chamber;
ii) causing a light source comprised by the chemiluminescence detection subsystem to emit light at one or more intensities; and
iii) for each of the one or more intensities, measuring light detected by the luminometer when the light source comprised by the chemiluminescence detection subsystem is emitting light at that intensity.

5. The method of claim 3 , wherein the method comprises:
a) determining that there is a fault in the laboratory instrument based on chemiluminescent light detected while performing the set of substrate blank check steps;
b) extending evaluation of the chemiluminescence detection subsystem by performing a set of substrate volume check steps comprising:
i) adding a predetermined volume of the substrate adapted to generate chemiluminescent light in reaction with ALP to a test vessel; and
ii) measuring the actual volume of the substrate adapted to generate chemiluminescent light in reaction with ALP in the test vessel using one or more images of the test vessel captured with a digital camera.

6. The method of claim 2 , wherein:
a) evaluating the sample dispensing subsystem comprises performing a set of luminometer sample volume check steps comprising:
i) for each of a set of one or more sample vessels:
A) adding a predetermined amount of an ALP solution to that sample vessel using a reagent pipettor;
B) moving a portion of the ALP solution from that sample vessel to a corresponding reaction vessel from a set of one or more reaction vessels using a sample pipettor comprised by the sample dispensing subsystem;

ii) for each of the set of one or more reaction vessels corresponding to a sample vessel from the set of one or more sample vessels:
A) adding a substrate adapted to generate chemiluminescent light in reaction with ALP to that reaction vessel;
B) using a luminometer comprised by the chemiluminescence detection subsystem, measuring chemiluminescent light from that reaction vessel after it has been spun, incubated and placed in a luminometer vessel chamber;

b) the method comprises:
i) determining that there is a fault in the laboratory instrument based on chemiluminescent light detected while performing the set of luminometer sample volume check steps; and
ii) addressing the fault by checking the sample pipettor position.

7. The method of claim 2 , wherein:
a) evaluating the sample dispensing subsystem comprises performing a set of luminometer sample volume check steps comprising:
i) for each of a set of one or more sample vessels:
A) adding a predetermined amount of an ALP solution to that sample vessel using a reagent pipettor;
B) moving a portion of the ALP solution from that sample vessel to a corresponding reaction vessel from a set of one or more reaction vessels using a sample pipettor comprised by the sample dispensing subsystem;

ii) for each of the set of one or more reaction vessels corresponding to a sample vessel from the set of one or more sample vessels:
A) adding a substrate adapted to generate chemiluminescent light in reaction with ALP to that reaction vessel;
B) using a luminometer comprised by the chemiluminescence detection subsystem, measuring chemiluminescent light from that reaction vessel after it has been spun, incubated and placed in a luminometer vessel chamber;

b) the method comprises:
i) determining that there is a fault in the laboratory instrument based on chemiluminescent light detected while performing the set of luminometer sample volume check steps; and
ii) extending evaluation of the sample dispensing subsystem by performing a set of camera sample volume check steps comprising:
A) for each of a plurality of extended diagnostic sample vessels:
I) dispensing a first volume of wash buffer into that extended diagnostic sample vessel using a reagent pipettor;
II) aspirating a second volume of wash buffer from that extended diagnostic sample vessel using the sample pipettor; and
III) capturing one or more digital camera images of that extended diagnostic sample vessel after aspiration of the second volume of wash buffer;

B) for each of a first set of extended diagnostic reaction vessels:
I) dispensing a third volume of wash buffer into that extended diagnostic reaction vessel using the sample pipettor; and
II) capturing one or more digital camera images of that extended diagnostic reaction vessel after dispensing of the third volume of wash buffer;

C) for each of a second set of extended diagnostic reaction vessels:
I) dispensing a fourth volume of wash buffer into that extended diagnostic reaction vessel using the sample pipettor; and
II) capturing one or more digital camera images of that extended diagnostic reaction vessel after dispensing of the fourth volume of wash buffer.

8. The method of claim 2 , wherein:
a) evaluating the sample dispensing subsystem comprises performing a set of luminometer sample volume check steps comprising:
i) for each of a set of one or more sample vessels:
A) adding a predetermined amount of an ALP solution to that sample vessel using a reagent pipettor;
B) moving a portion

Assignees

• Beckman Coulter Inc

Inventors

• Mizutani Takayuki
• Kubota Kiyotaka
• Erickson Carl
• Maik Scott
• Sovde Nicole

Classifications

• G01N2035/1025

  Fluid level sensing · CPC title

• G01N2035/00653

  statistical methods comparing labs or apparatuses · CPC title

• G01N35/1016

  Control of the volume dispensed or introduced · CPC title

• G01N35/00712

  Automatic status testing, e.g. at start-up or periodic · CPC title

• G01N21/76

  Chemiluminescence; Bioluminescence · CPC title