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US 12,742,774 B2Granted
Methods for detecting aberrant results caused by incomplete delivery of a polyhapten reagent in immunoassays
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsAmy Tyler, Tie Wei
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Abstract
Methods of detecting aberrant results caused by delivery issues for a polyhapten reagent in the context of immunoassays are disclosed.
Claims15
A method of detecting aberrant results caused by incomplete delivery of a polyhapten reagent used in an inhibition immunoassay, the method comprising the steps of:
- (A) inserting a reaction cuvette into a clinical chemistry analyzer system and reacting, within the reaction cuvette, a biological sample suspected of containing a target analyte with a target analyte-specific binding partner, thereby forming a soluble analyte/specific binding partner complex;
- (B) adding a polyhapten reagent to the reaction cuvette, wherein the polyhapten reagent comprises multiple copies of an epitope of the target analyte to which the target analyte-specific binding partner binds, and wherein the polyhapten reagent reacts with excess target analyte-specific binding partner to form an insoluble polyhapten/target analyte-specific binding partner complex;
- (C) irradiating the reaction cuvette with light at at least three wavelengths, wherein a first wavelength turbidimetrically detects the insoluble polyhapten/target analyte-specific binding partner complex, the second wavelength detects the polyhapten reagent, and the third wavelength serves as a blank, and wherein the first wavelength is about 340 nm, the second wavelength is about 293 nm, and the third wavelength is about 700 nm;
- (D) measuring absorbance values at the first, second, and third wavelengths at at least two time points following a time of delivery of the polyhapten reagent, wherein absorbance values at the first wavelength provide an indication of a concentration value for the target analyte, absorbance values at the second wavelength provide an indication of the polyhapten reagent, and wherein there is minimal to no protein/peptide detection at the third wavelength;
- (E) extrapolating an absorbance value for the polyhapten reagent at the time of delivery thereof using a regression of absorbance values measured at the second and third wavelengths at two time points following the time of delivery of the polyhapten reagent;
- and
- (F) reporting to a user that a concentration value for the target analyte obtained by a separate algorithm has been flagged as unacceptable if the extrapolated absorbance value for the polyhapten reagent at the time of delivery thereof varies from a predicted value therefor by more than an established flag constant, the established flag constant set in order to flag results that are significantly impacted by incomplete delivery of the polyhapten reagent.
4 more elements
A method of detecting aberrant results caused by incomplete delivery of a polyhapten reagent used in a glycated hemoglobin (HbA1c) inhibition immunoassay, the method comprising the steps of:
- (A) inserting a reaction cuvette into a clinical chemistry analyzer system and reacting, within the reaction cuvette, a biological sample suspected of containing a target analyte comprising HbA1c with an anti-HbA1c antibody to the target analyte, thereby forming a soluble HbA1c-antibody complex;
- (B) adding a polyhapten reagent to the reaction cuvette, wherein the polyhapten reagent comprises multiple copies of an epitope of HbA1c to which the anti-HbA1c antibody binds, and wherein the polyhapten reagent reacts with excess anti-HbA1c antibody to form an insoluble polyhapten/anti-HbA1c antibody complex;
- (C) irradiating the reaction cuvette with light at at least three wavelengths, wherein a first wavelength turbidimetrically detects the insoluble polyhapten/anti-HbA1c complex, the second wavelength detects the polyhapten reagent, and the third wavelength serves as a blank, and wherein the first wavelength is about 340 nm, and the second wavelength is about 293 nm, and the third wavelength is about 700 nm;
- (D) measuring absorbance values at the first, second, and third wavelengths at at least two time points following a time delivery of the polyhapten reagent, wherein absorbance values at the first wavelength provide an indication of a concentration value for HbA1c, absorbance values at the second wavelength provide an indication of the polyhapten reagent, and wherein there is minimal to no protein/peptide detection at the third wavelength;
- (E) extrapolating an absorbance value for the polyhapten reagent at the time of delivery thereof using a regression of absorbance values measured at the second and third wavelengths at two time points following the time of delivery of the polyhapten reagent;
- and
- (F) reporting to a user that a concentration value for HbA1c obtained by a separate algorithm has been flagged as unacceptable if the extrapolated absorbance value for the polyhapten reagent at the time of delivery thereof varies from a predicted value therefor by more than an established flag constant, the established flag constant set in order to flag results that are significantly impacted by incomplete delivery of the polyhapten reagent.
4 more elements
A method of detecting aberrant results caused by incomplete delivery of a polyhapten reagent used in a glycated hemoglobin (HbA1c) inhibition immunoassay, the method comprising the steps of:
- (A) inserting a reaction cuvette into a clinical chemistry analyzer system and reacting, within the reaction cuvette, a biological sample suspected of containing a target analyte comprising HbA1c with an anti-HbA1c antibody to the target analyte, thereby forming a soluble HbA1c-antibody complex;
- (B) adding a polyhapten reagent to the reaction cuvette, wherein the polyhapten reagent comprises multiple copies of an epitope of HbA1c to which the anti-HbA1c antibody binds, and wherein the polyhapten reagent reacts with excess anti-HbA1c antibody to form an insoluble polyhapten/anti-HbA1c antibody complex;
- (C) irradiating the reaction cuvette with light at at least three wavelengths, wherein a first wavelength turbidimetrically detects the insoluble polyhapten/anti-HbA1c complex, the second wavelength detects the polyhapten reagent, and the third wavelength serves as a blank;
- (D) measuring absorbance values at multiple time points at at least three wavelengths following addition of the polyhapten reagent, wherein:
- (i) a first wavelength is about 340 nm and turbidimetrically detects the insoluble polyhapten/anti-HbA1c antibody complex;
- (ii) a second wavelength is about 293 nm and detects the polyhapten reagent;
- and
- (iii) a third wavelength serves as a blank whereby there is minimal to no protein/peptide detection at said wavelength, and wherein the third wavelength is about 700 nm;
- (E) extrapolating an absorbance value for the polyhapten reagent at the time of delivery thereof using a regression of absorbance values measured at the second and third wavelengths at two time points following the time of delivery of the polyhapten reagent;
- and
- (F) reporting to a user that a concentration value for HbA1c obtained by a separate algorithm has been flagged as unacceptable if the extrapolated absorbance value for the polyhapten reagent at the time of delivery thereof varies from a predicted value therefor by more than an established flag constant, the established flag constant set in order to flag results that are significantly impacted by incomplete delivery of the polyhapten reagent.
8 more elements
Dependencies are inferred from the claim text.