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Additive for measuring diluted sample in non-dilution-type immunochromatographic method reagent

A technique of immunochromatography and immunochromatography, which is applied in the direction of measuring devices, analytical materials, instruments, etc., can solve problems such as changes in detection intensity, extension of test solution spreadability, etc., and achieve accurate measurement results

Active Publication Date: 2015-07-29
SEKISUI MEDICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In this document, it is described that if the weight-average molecular weight is greater than 9000 and the concentration of the nonionic water-soluble polymer in the test sample is increased to obtain a sufficient reaction acceleration effect, the deterioration of the test solution spreadability prolongs to obtain a constant The time required for color development or the detected intensity of the marker varies between test strips

Method used

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  • Additive for measuring diluted sample in non-dilution-type immunochromatographic method reagent
  • Additive for measuring diluted sample in non-dilution-type immunochromatographic method reagent
  • Additive for measuring diluted sample in non-dilution-type immunochromatographic method reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] [Example 1]

[0046] The same operation as in Comparative Example 1 was performed except that the plasma was diluted tenfold with PBS containing BSA or HES at the concentrations indicated in Table 1. For HES, a HESPANDER (registered trademark) fluid solution (manufactured and sold by Fresenius Kabi Japan; weight average molecular weight: about 70,000, degree of substitution of hydroxyethyl groups: 0.50 to 0.55; HES concentration: 6% by weight) was used. The HES concentrations in Table 1 represent the actual HES concentrations in the dilutions.

[0047] The measurement results are shown in Table 1.

[0048] In the case of dilution with PBS containing BSA or HES, an improvement in recovery relative to the reference value was confirmed.

[0049] The improvement effect of HES was greater than that of BSA in the concentration range studied.

[0050] [Table 1]

[0051]

[0052] Conc.: Concentration, wt.: Weight

[0053] Blank indicates no experiment was performed.

Embodiment 2

[0054] [Example 2]

[0055] The same operation as in Comparative Example 1 was performed except that the plasma was diluted tenfold with PBS containing HES at the concentrations indicated in Table 2 and 1.0% BSA.

[0056] The measurement results are described in Table 2.

[0057] The recovery relative to the reference was further improved by allowing the coexistence of HES and BSA.

[0058] [Table 2]

[0059] HES concentration (weight%)

Embodiment 3

[0060] [Example 3]

[0061] The same operation as in Comparative Example 1 was carried out except that plasma (nine samples) each yielding a measured value equal to or greater than 800 pg / mL and equal to or less than 2000 pg / mL in the measurement by MI02 Shionogi BNP (SHIONOGI) was washed with PBS ( Comparative Example 2) or PBS containing 1.5% HES and 1.0% BSA (Example 3) was diluted tenfold. Investigate the correlation with MI02 Shionogi BNP.

[0062] The measurement results are displayed on figure 2 middle.

[0063] When the measurement was performed on whole blood diluted with PBS containing 1.5% HES and 1.0% BSA (Example 3), compared with the measurement performed on whole blood diluted with PBS (Comparative Example 2), compared with the reference value correlation is improved.

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Abstract

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.

Description

technical field [0001] The present invention relates to immunochromatographic method (immunochromatographic method). Background technique [0002] In the field of clinical examinations, it is extremely common to use measurement reagents of immunochromatography which require simple operation and short measurement time and can realize measurement with a small and inexpensive device even in the case of quantification. In order to further improve simplicity and rapidity, there is an increasing demand for the development of immunochromatographic methods that allow direct use of blood samples (whole blood, serum or plasma) as samples without pretreatment such as dilution. [0003] However, even in the case of immunochromatography using a measurement system designed in such a way that a blood sample can be directly used as a sample, if the concentration of the analyte in the blood sample is high enough to exceed the upper limit of quantification of the measurement system, it must ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543
CPCG01N33/558G01N33/543G01N33/54388G01N33/54366G01N33/54393
Inventor 吉田万友美森田元喜山本光章
Owner SEKISUI MEDICAL CO LTD
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