CA2330759A1 - Failure detection in automated clinical analyzers - Google Patents

Failure detection in automated clinical analyzers Download PDF

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Publication number
CA2330759A1
CA2330759A1 CA002330759A CA2330759A CA2330759A1 CA 2330759 A1 CA2330759 A1 CA 2330759A1 CA 002330759 A CA002330759 A CA 002330759A CA 2330759 A CA2330759 A CA 2330759A CA 2330759 A1 CA2330759 A1 CA 2330759A1
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CA
Canada
Prior art keywords
fluid
vessel
dispensed
determining
metering
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002330759A
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French (fr)
Other versions
CA2330759C (en
Inventor
Randy Kristopher Bower
Michael Avdenko
Joseph John Dambra
Merrit Nyles Jacobs
David Donald Hyde
James Daniel Riall
Stuart Gilmour Macdonald
James David Shaw
Mark Alan Simon
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Ortho Clinical Diagnostics Inc
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Individual
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Filing date
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Publication of CA2330759A1 publication Critical patent/CA2330759A1/en
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Publication of CA2330759C publication Critical patent/CA2330759C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00603—Reinspection of samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G01N35/00623—Quality control of instruments
    • G01N2035/00653—Quality control of instruments statistical methods comparing labs or apparatuses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N35/1016—Control of the volume dispensed or introduced
    • G01N2035/1018—Detecting inhomogeneities, e.g. foam, bubbles, clots
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N2035/1025—Fluid level sensing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N35/1016—Control of the volume dispensed or introduced
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/11—Automated chemical analysis
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/11—Automated chemical analysis
    • Y10T436/119163—Automated chemical analysis with aspirator of claimed structure
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/2575—Volumetric liquid transfer

Abstract

The invention is a method for detecting failures in an analyzer for conducting clinical assays. Potential errors that can result in assay failures in an analyzer are identified, as are their potential sources. The probability that an error source so identified will result in a clinically significant error is also determined. Available potential detection measures corresponding to the source of potential errors are identified with a combination of such measures selected and implemented based on their probability of detecting such errors within an acceptable limit with a concomitant low probability of the false detection of an assay failure. Each of the measures selected are functionally independent of others chosen to address the source of the error and are not subject to the same inherent means of failed detection. Applications of the method in a clinical analyzer are also presented.

Claims (17)

1. A method for detecting failures in an analyzer for conducting clinical assays comprising:

a) identifying potential errors that can result in assay failures in an analyzer b) identifying potential sources of the potential errors identified in a), c) determining the probability that an error source so identified will result in a clinically significant error, d) identifying potential error detection measures corresponding to the source of potential errors, c) selecting and implementing such error detection measures based on their probability of reducing errors to an acceptable limit along with a low probability of the false detection of an assay failure.
2. The method of claim 1 wherein the step of selecting error detection measures is done quantitatively.
3. The method of claim 1 conducted in an automated manner.
4. The method of claim 3 conducted by employing linear programming processes.
5. A method of detecting fluid metering failures comprising:
a) rapidly flushing a fluid delivery vessel with a fluid so that a foam is formed by the flushed liquid, b) measuring the height of the foam within the vessel, c) determining the volume of the dispensed liquid, e) evaluating the sufficiency of the volume of the dispensed liquid, and f) identifying insufficient volumes as fluid metering failures.
6. The method of claim 5 wherein said measuring step is conducted by a liquid level sensor.
7. The method of claim 6 wherein said level sensor is a pressure sensing, capacitance, reflected energy, or visual detection sensor.
8. The method of claim 5 wherein the method of testing fluid is fast enough so that it can be done on every actuation without impacting system throughput or probe wash efficiency.
9. The method of claim 5 wherein the method is able to detect:

a) partially plugged reagent probes, b) fully plugged reagent probes, and c) failed valves.
10. A method of detecting failures in assays that require sample dilution comprising:
a) aspirating sample in a fluid delivery device, b) metering sample into a dilution vessel, c) metering diluent is metered into said dilution vessel, d) determining the volume of b) and c), e) determining the sufficiency of the measurement taken in d), and f) identifying as a failure insufficiencies identified in e).
11. The method of claim 10 further comprising the steps of g) metering reagent into the dilution vessel, and h) determining the volume of either i) the sample plus diluent plus reagent or,ii) sample plus diluent.
12. A carryover free fluid delivery and verification device comprising a hollow vessel through which fluid is dispensed having an end out of which fluid is dispensed, said vessel being in contact with a transducer, wherein said end out of which fluid is dispensed comprises a geometry resistant to carryover.
13. The device of claim 15 wherein said end out of which fluid is dispensed is notched.
14. A method of detecting analyzer failures comprising:

I) a) rapidly flushing a fluid delivery vessel with a fluid so that a foam is formed by the flushed liquid, b) measuring the height of the foam within the vessel, c) determining the volume of the dispensed liquid, e) evaluating the sufficiency of the volume of the dispensed liquid, f) identifying insufficient volumes as fluid metering failures, and II) a) aspirating sample in a fluid delivery device, b) metering sample into a dilution vessel, c) metering diluent is metered into said dilution vessel, d) determining the volume of b) and c), e) determining the sufficiency of the measurement taken in d), and f) identifying as a failure insufficiencies identified in e).
15. A method of detecting analyzer failures comprising:
I) a) rapidly flushing a fluid delivery vessel with a fluid so that a foam is formed by the flushed liquid, b) measuring the height of the foam within the vessel, c) determining the volume of the dispensed liquid, e) evaluating the sufficiency of the volume of the dispensed liquid, f) identifying insufficient volumes as fluid metering failures, and II) a) aspirating sample in a fluid delivery device, b) metering sample into a dilution vessel, c) metering diluent is metered into said dilution vessel, d) determining the volume of b) and c), e) determining the sufficiency of the measurement taken in d), and f) identifying as a failure insufficiencies identified in e), and III) employing a carryover free fluid delivery and verification device comprising a hollow vessel through which fluid is dispensed having an end out of which fluid is dispensed, said vessel being in contact with a transducer, wherein said end out of which fluid is dispensed comprises a geometry resistant to carryover.
16. The method of claim 1 implemented by a computer program interfacing with a computer.
17. An article of manufacture comprising a computer usable medium having computer readable program code configured to conduct the process of claim 1.
CA2330759A 2000-01-13 2001-01-11 Failure detection in automated clinical analyzers Expired - Lifetime CA2330759C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US48259900A 2000-01-13 2000-01-13
US09/482,599 2000-01-13

Publications (2)

Publication Number Publication Date
CA2330759A1 true CA2330759A1 (en) 2001-07-13
CA2330759C CA2330759C (en) 2012-03-13

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CA2330759A Expired - Lifetime CA2330759C (en) 2000-01-13 2001-01-11 Failure detection in automated clinical analyzers

Country Status (8)

Country Link
US (1) US8026101B2 (en)
EP (1) EP1116953A3 (en)
JP (1) JP4913284B2 (en)
KR (1) KR100815414B1 (en)
CN (2) CN101363871B (en)
AU (2) AU777102B2 (en)
CA (1) CA2330759C (en)
HK (1) HK1037725A1 (en)

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Also Published As

Publication number Publication date
JP4913284B2 (en) 2012-04-11
CN1307239A (en) 2001-08-08
AU1000401A (en) 2001-07-19
CA2330759C (en) 2012-03-13
HK1037725A1 (en) 2002-02-15
AU2004242539A1 (en) 2005-01-27
AU2004242539B2 (en) 2007-08-09
KR100815414B1 (en) 2008-03-20
JP2001221804A (en) 2001-08-17
KR20010076249A (en) 2001-08-11
CN101363871A (en) 2009-02-11
US8026101B2 (en) 2011-09-27
US20050196867A1 (en) 2005-09-08
AU777102B2 (en) 2004-09-30
CN101363871B (en) 2012-10-03
EP1116953A2 (en) 2001-07-18
CN100419429C (en) 2008-09-17
EP1116953A3 (en) 2003-10-08

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