Hydroxyethyl Starch Additive for Immunochromatographic Measurement Accuracy
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Solution Overview
Problem
The immunochromatographic method faces deviations in measurement values when using undiluted blood specimens as samples, especially when analyte concentrations exceed the upper limit of quantitation, leading to inaccurate results.
Innovation Solution
Incorporating hydroxyethyl starch (HES) into the immunochromatographic device or blood specimen diluent to reduce deviations in measurement values, allowing for accurate quantitation even with diluted samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a diluted blood specimen is used as a sample when analyte concentration exceeds upper limit of quantitation, then the measurement system can handle high concentration samples, but deviations from theoretical values occur and measurement accuracy deteriorates
Solution Approach 1:
Hydroxyethyl starch acts as an intermediary substance that mediates between the diluted blood specimen and the immunochromatographic measurement system. It is incorporated into the measurement system (in the membrane or conjugate pad) to prevent direct adverse interactions between the diluted sample and the assay components, thereby reducing measurement deviations while maintaining the ability to handle high concentration samples through dilution
Solution Approach 2:
The invention changes the compositional parameters of the measurement system by incorporating hydroxyethyl starch at specific concentrations (0.1-10% by mass in the membrane, or 0.01-1% in the conjugate pad). This parameter change modifies the measurement environment to reduce deviations from theoretical values when diluted blood specimens are used, thereby improving measurement accuracy
2Productivity
If nonionic water-soluble polymer with molecular weight greater than 9000 is used as reaction accelerator, then reaction-accelerating effect is sufficient, but spreadability of tested solution deteriorates and detection time increases
Solution Approach 1:
The invention changes the molecular weight parameter of the nonionic water-soluble polymer from greater than 9000 to between 2000 and 9000. This parameter optimization maintains sufficient reaction-accelerating effect while improving spreadability of the tested solution, thereby reducing the time required to achieve constant color development in the detection site
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The use of hydroxyethyl starch suppresses deviations from theoretical values, enabling accurate measurements with diluted blood specimens, thus preventing reductions in measurement accuracy.
Implementation Method 1
when measurement is performed in the presence of hydroxyethyl starch at the time of measurement of a diluted blood specimen in a non-dilution method, the deviation from the theoretical value can be reduced
Data Source
Figure 1~2
AI summary
Provided are: an immunoassay method in which the deviation from a theoretical value (hereinafter also referred to as "a reference value"), which may be caused when a diluted blood specimen is used as a sample, is reduced in an immunochromatographic method that is so designed that a blood specimen (whole blood, serum or plasma) is used directly as a sample without subjecting the blood specimen to any pretreatment such as a dilution treatment; and a reagent for use in the method. An immunochromatographic method performed on a blood specimen using an immunochromatographic device equipped with (1) a sample pad and (2) a membrane on which a component capable of specifically binding to an analyte is immobilized, arranged in the order of (1) and (2) from upstream, wherein hydroxyethyl starch is present in the measurement system.