Determination of an analyte
First Claim
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1. A method of recalibrating in an analyzer, a calibration relationship between concentrations of analyte and analyzer-generated signals corresponding to those concentrations, using a factory-prepared relationship for N number of concentrations, wherein each concentration has an expected signal value Rexp, the method comprising the steps of:
- a) selecting at least two calibrators of differing concentrations one being higher in analyte value than the other, so that one (C1) is at a high concentration and one (C2) at a low concentration, respectively, that are optionally independent of the value of the concentrations of said N number;
b) ascertaining actual signals Ract1 +Ract2 produced by each of said at least two calibrators in said analyzer;
c) ascertaining which of said N number of concentrations (Ci)low have an expected signal value below the actual signal of said low concentration-selected calibrator of step a) and which concentrations (Ci)high have an expected signal value greater than the actual signal of said high concentration-selected calibrator of step a);
d) forming the ratio of Ract1 /Rexp1 and Ract2 /Rexp2, where Rexp1 and Rexp2 are predicted signals expected for concentration C1 and C2 using said factory-prepared relationship;
e) producing a corrected signal for each of said concentrations (Ci)low by multiplying each signal (Rexp)low for each of said below concentration values by the ratio Ract1 /Rexp1 and a corrected signal for each of said concentrations (Ci)high by multiplying each signal (Rexp)high for each of said greater concentration values by the ratio Ract2 /Rexp2 ;
f) for each of said N number of concentrations having values between C1 and C2, producing a corrected signal PSremainder in accord with the following formula;
space="preserve" listing-type="equation">PS.sub.remainder =(R.sub.act2 -R.sub.act1)/(R.sub.exp2 -R.sub.exp1)·
(R.sub.expremainder -R.sub.exp1)+R.sub.act1 ;
g) ascertaining the relationship for the corrected signals so obtained in steps e)-f) versus the N number of concentrations; and
h) providing a best curve fit for data points between the N number of concentrations to obtain the recalibrated relationship.
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Abstract
A method and kit are disclosed for recalibrating a factory-prepared relationship between concentration and expected signal Rexp produced by an analyzer. The method and kit use two or three calibrators at the field to obtain an actual signal Ract for the two calibrators Clow and Chigh, for example, and these two actual signals are used to create a ratio of Ractlow /Rexplow and Racthigh /Rexphigh. The first of these is used to correct the expected signals for concentrations below the lower calibrator concentration, and the second is used to correct expected signals for concentrations above the higher calibrator concentration, producing pseudosignals PSlow and PShigh. A straight-line relationship is applied between the corrected PSlow and PShigh, and that relationship is used for concentrations between Clow and Chigh.
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Citations
4 Claims
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1. A method of recalibrating in an analyzer, a calibration relationship between concentrations of analyte and analyzer-generated signals corresponding to those concentrations, using a factory-prepared relationship for N number of concentrations, wherein each concentration has an expected signal value Rexp, the method comprising the steps of:
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a) selecting at least two calibrators of differing concentrations one being higher in analyte value than the other, so that one (C1) is at a high concentration and one (C2) at a low concentration, respectively, that are optionally independent of the value of the concentrations of said N number; b) ascertaining actual signals Ract1 +Ract2 produced by each of said at least two calibrators in said analyzer; c) ascertaining which of said N number of concentrations (Ci)low have an expected signal value below the actual signal of said low concentration-selected calibrator of step a) and which concentrations (Ci)high have an expected signal value greater than the actual signal of said high concentration-selected calibrator of step a); d) forming the ratio of Ract1 /Rexp1 and Ract2 /Rexp2, where Rexp1 and Rexp2 are predicted signals expected for concentration C1 and C2 using said factory-prepared relationship; e) producing a corrected signal for each of said concentrations (Ci)low by multiplying each signal (Rexp)low for each of said below concentration values by the ratio Ract1 /Rexp1 and a corrected signal for each of said concentrations (Ci)high by multiplying each signal (Rexp)high for each of said greater concentration values by the ratio Ract2 /Rexp2 ; f) for each of said N number of concentrations having values between C1 and C2, producing a corrected signal PSremainder in accord with the following formula;
space="preserve" listing-type="equation">PS.sub.remainder =(R.sub.act2 -R.sub.act1)/(R.sub.exp2 -R.sub.exp1)·
(R.sub.expremainder -R.sub.exp1)+R.sub.act1 ;g) ascertaining the relationship for the corrected signals so obtained in steps e)-f) versus the N number of concentrations; and h) providing a best curve fit for data points between the N number of concentrations to obtain the recalibrated relationship. - View Dependent Claims (2, 3, 4)
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Current AssigneeClinical Diagnostic Systems Inc.
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Original AssigneeJohnson & Johnson Clinical Diagnostics Inc. (Johnson & Johnson)
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InventorsDoyle, Kevin P. J., Chadney, Donovan C.
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Primary Examiner(s)Housel, James C.
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Assistant Examiner(s)FREED, RACHEL
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Application NumberUS08/360,481Time in Patent Office629 DaysField of Search436/8.63, 436/824, 73/1 R, 364/571.01, 364/571.04, 364/571.05US Class Current436/8CPC Class CodesG01N 2035/00752 bar codesG01N 2035/00762 magnetic codeG01N 2035/00782 reprogrammmable codeG01N 2201/127 Calibration; base line adju...G01N 35/00594 Quality control, including ...G01N 35/00693 CalibrationG01N 35/00732 Identification of carriers,...Y10T 436/10 Composition for standardiza...
