Automated method and apparatus for detecting erroneous sample collection in clinical assays

• US 8,548,772 B2
• Filed: 08/03/2012
• Issued: 10/01/2013
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Brouwer, Eric, Tirinato, Jody Ann, Zelin, Michael P.
• Primary Examiner(s): Gakh, Yelena G
• Assistant Examiner(s): Adams, Michelle
• Application Number:
  US13/565,930
• Publication Number:
  US 20120295359A1
• Time in Patent Office: 424 Days
• Field of Search: None
• US Class Current: 702/185
• CPC Class Codes: G01N 35/00603 Reinspection of samples
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

An automatic method for identifying biological samples that are collected using the wrong blood preservative for subsequent analytical testing. The method also provides for identification and/or suppression of certain analytical test results that are substantially or partly adversely affected. The invention is particularly suited for use in point-of-care medical diagnostic testing.

Claims

1. A method of identifying erroneous collection of a sample for a measurement of a first species in a collection device comprising a reagent incompatible with a reliable measurement of said first species, said method comprising:

taking the sample from said collection device;

determining a concentration of said first species;

determining a concentration of a second species in said sample with respect to a threshold value;

when the concentration of the second species is beyond said threshold value, flagging or suppressing a reporting of the determined concentration of said first species and the determined concentration of said second species, and reporting the collection device as being inappropriate for collection of said sample for the reliable measurement of said first species; and

when the concentration of the second species is not beyond said threshold value, flagging or suppressing the determined concentration of the first species if the determined concentration of the first species is outside of a reportable range for the first species, flagging or suppressing the determined concentration of the second species if the determined concentration of the second species is outside of a reportable range for the second species, and not reporting the collection device as being inappropriate for collection of said sample for the reliable measurement of said first species,

wherein said first species is one of a plurality of species in said sample.

2. An automatic method for determining that a sample was collected with a wrong anticoagulant, the method comprising:

(a) adding the sample to an analyzer instrument having means for analyzing analyte species within the sample that include a divalent cation and one or more other analytes,

(b) determining a concentration of the divalent cation and a concentration of the one or more other analytes in said sample,

(c) comparing the determined concentration of the divalent cation to a predetermined lower threshold value,

(d) when said predetermined lower threshold value is surpassed by the determined concentration of the divalent cation, said analyzer instrument flags or suppresses the determined concentration of the divalent cation and the determined concentration of the one or more other analytes in said sample, and reports that the sample was collected with the wrong anticoagulant, and

(e) when said predetermined lower threshold value is not surpassed by the determined concentration of the divalent cation, said analyzer instrument does not flag or suppress the determined concentration of the divalent cation and the determined concentration of the one or more other analytes if the determined concentration of the one or more other analytes is not outside of a reportable range for the one or more other analytes, and said analyzer instrument does not report that the sample was collected with the wrong anticoagulant.

3. The method of claim 2, wherein the divalent cation is calcium.

4. The method of claim 2, wherein said one or more other analytes is selected from the group consisting of:

magnesium, potassium sodium, hydrogen, chloride, bicarbonate, ammonium, lithium, pH, partial pressure of carbon dioxide (pCO₂), partial pressure of oxygen (pO₂), glucose, creatinine, lactate, blood urea nitrogen, and hematocrit.

5. The method of claim 2, wherein the divalent cation is calcium and the predetermined lower threshold value is a selected value in the range of about 0.3 mM to about 0.001 mM.

6. The method of claim 2, wherein the wrong anticoagulant is selected from the group consisting of:

K₂EDTA, K₃EDTA, and Na₂EDTA, oxalic acid and salts thereof, ethylene glycol tetra acetic acid (EGTA) and salts thereof, citric acid and salts thereof, fluorides, non-balanced heparins, and combinations thereof.

7. A method of identifying erroneous collection of a sample for a measurement of a first species in a collection device comprising a reagent incompatible with a reliable measurement of said first species, said method comprising:

taking the sample from said collection device;

determining a concentration of said first species;

determining a concentration of a second species in said sample with respect to a threshold value;

when the concentration of the second species is beyond said threshold value, flagging or suppressing a reporting of the determined concentration of said first species and the determined concentration of said second species, and reporting the collection device as being inappropriate for collection of said sample for the reliable measurement of said first species; and

when the concentration of the second species is not beyond said threshold value, flagging or suppressing the determined concentration of the first species if the determined concentration of the first species is outside of a reportable range for the first species, flagging or suppressing the determined concentration of the second species if the determined concentration of the second species is outside of a reportable range for the second species, and not reporting the collection device as being determined to be inappropriate for collection of said sample for the reliable measurement of said first species,

wherein said second species is one of a plurality of species.

8. A method of identifying erroneous collection of a sample for a measurement of at least one species in a collection device containing a reagent incompatible with a reliable measurement of said at least one species, the method comprising:

taking the sample from said collection device;

determining a concentration of said at least one species;

determining a concentration of a plurality of other species in the sample with respect to a threshold value;

when the concentration of the plurality of other species is beyond said threshold value, flagging or suppressing a reporting of the determined concentration of said plurality of other species and the determined concentration said at least one species, and reporting the collection device as being inappropriate for collection of said sample for the reliable measurement of said at least one species; and

when the concentration of the plurality of other species is not beyond said threshold value, flagging or suppressing the determined concentration of the at least one species if the determined concentration of the at least one species is outside of a reportable range for the at least one species, flagging or suppressing the determined concentration of the plurality of other species if the determined concentration of the plurality of other species is outside of a reportable range for the plurality of other species, and not reporting the collection device as being inappropriate for collection of said sample for the reliable measurement of said at least one species.

9. An automatic method for determining that a collection device was incorrectly used to collect a bleed sample for analysis of ionic species, the method comprising:

adding the sample from the collection device to an analyzer instrument having means for analyzing said ionic species that include a divalent cation and one or more other ionic species;

determining a concentration of the divalent cation and a concentration the one or more other ionic species in said sample;

comparing the concentration of the divalent cation to a predetermined threshold value;

when said predetermined threshold value is surpassed by the determined concentration of the divalent cation, said analyzer instrument flags or suppresses the determined concentration of the divalent cation and the determined concentration of the one or more other ionic species in said sample, and said analyzer instrument reports that the sample was incorrectly collected using the collection device; and

when said predetermined lower threshold value is not surpassed by the determined concentration of the divalent cation, said analyzer instrument flags or suppresses the determined concentration of the divalent cation if the determined concentration of the divalent cation is outside of a reportable range for the divalent cation, said analyzer instrument flags or suppresses the determined concentration of the one or more other ionic species if the determined concentration of the one or more other ionic species is outside of a reportable range for the one or more other ionic species, and said analyzer instrument does not report that the sample was incorrectly collected using the collection device.

10. The method of claim 9, wherein the collection device comprises EDTA.

11. An automatic analyte testing method for distinguishing samples incorrectly collected with a wrong anticoagulant from samples collected using a correct anticoagulant, the method comprising:

(a) introducing a sample into an analyzer instrument having means for determining a concentration of a first analyte and a concentration of a second analyte in said sample;

(b) comparing the concentration of the first analyte concentration to a predetermined threshold concentration value;

(c) when the predetermined threshold concentration value is not surpassed by the concentration of the first analyte, reporting by said analyzer instrument the concentration of the first analyte and the concentration of the second analyte, and not reporting by said analyzer instrument that the sample was incorrectly collected with the wrong anticoagulant, and

(d) when the predetermined threshold concentration value is surpassed by the concentration of the first analyte, reporting by said analyzer instrument that the concentration of the first analyte and the concentration of the second analyte should not be used, and reporting by said analyzer instrument that the sample was incorrectly collected with the wrong anticoagulant.