Automated methods for detecting sample collection with erroneous anticoagulant in clinical assays
First Claim
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1. An automatic method for determining that a collection device was incorrectly used to collect a sample for analysis of analyte species in the sample, the method comprising:
- (a) adding the sample to an analyzer instrument having means for analyzing species that include a monovalent cation, a divalent cation, and one or more other analytes, wherein the sample is from the collection device;
(b) determining a concentration of the monovalent cation, a concentration of the divalent cation, and a concentration of the one or more other analytes in said sample;
(c) comparing the monovalent cation concentration to a predetermined upper threshold concentration value and the divalent cation concentration to a predetermined lower threshold concentration value; and
(d) reporting by said analyzer instrument that the sample was collected with a wrong anticoagulant when both said threshold concentration values are surpassed, but not when only one of said threshold concentration values is surpassed, where a correct collection device for the sample omits a selected anticoagulant.
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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.
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Citations
39 Claims
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1. An automatic method for determining that a collection device was incorrectly used to collect a sample for analysis of analyte species in the sample, the method comprising:
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(a) adding the sample to an analyzer instrument having means for analyzing species that include a monovalent cation, a divalent cation, and one or more other analytes, wherein the sample is from the collection device; (b) determining a concentration of the monovalent cation, a concentration of the divalent cation, and a concentration of the one or more other analytes in said sample; (c) comparing the monovalent cation concentration to a predetermined upper threshold concentration value and the divalent cation concentration to a predetermined lower threshold concentration value; and (d) reporting by said analyzer instrument that the sample was collected with a wrong anticoagulant when both said threshold concentration values are surpassed, but not when only one of said threshold concentration values is surpassed, where a correct collection device for the sample omits a selected anticoagulant. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. A method of identifying an erroneous blood sample collection for measurement of one or more ionic species in a collection device containing a cationic salt of a calcium binding agent, the method comprising:
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taking a blood sample from the collection device; determining a concentration of a monovalent cation in the blood sample with respect to an upper threshold value; determining a concentration of calcium cation in the blood sample with respect to a lower threshold value; flagging or suppressing a reporting of the monovalent cation, calcium cation and at least one other measured ionic species in said blood sample when both the monovalent cation concentration is above the upper threshold value and the calcium cation concentration is below the lower threshold value; and reporting that the collection device is an inappropriate type for collection of the blood sample for the measurement of one or more other selected ionic species when both the monovalent cation concentration is above the upper threshold value and the calcium cation concentration is below the lower threshold value, but not when only one of said threshold values is surpassed. - View Dependent Claims (32, 33, 34, 35, 36, 37)
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38. A method of identifying erroneous collection of a biological sample in a collection device containing a reagent incompatible with reliable measurement of a monovalent cation and a divalent cation, said method comprising:
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taking the biological sample from the collection device; determining a concentration of the monovalent cation in the biological sample with respect to an upper threshold value; determining a concentration of the divalent cation in the biological sample with respect to a lower threshold value; flagging or suppressing a reporting of the monovalent cation and the divalent cation in said biological sample when both the monovalent cation concentration is above the upper threshold value and the divalent cation concentration is below the lower threshold value; and reporting that the collection device is suspected of being an inappropriate type for collection of the biological sample for the reliable measurement of the monovalent cation and the divalent cation when both the monovalent cation concentration is above the upper threshold value and the calcium cation concentration is below the lower threshold value, but not when only one of said threshold values is surpassed. - View Dependent Claims (39)
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Specification