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Porous solid phase for binding assay, and binding assay method using the same

一种多孔性、类固醇的技术，应用在测量装置、仪器、科学仪器等方向，能够解决没有解决测量波形扰动问题、不存在解决方案等问题，达到优异再现性、防止假阴性和假阳性、防止流动行进不良的效果

Active Publication Date: 2011-05-25
SEKISUI MEDICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The prior art does not address the perturbation of the measured waveform, so there is no known solution to this problem

Method used

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  • Porous solid phase for binding assay, and binding assay method using the same
  • Porous solid phase for binding assay, and binding assay method using the same
  • Porous solid phase for binding assay, and binding assay method using the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0147] Example 1: Manufacture of an immunochromatographic device using a test strip according to the invention

[0148] (1) Preparation of the membrane of the present invention (porous solid phase for binding assay) on which anti-DD antibody is immobilized

[0149] A nitrocellulose membrane ("HF240" manufactured by Millipore) was soaked in 10 mmol / l phosphate buffer (pH 7.2) containing the surfactant of the present invention shown in Table 1 at a concentration of 0.05% (w / v), and shake at room temperature for 30 minutes. After removing excess liquid, the membrane was dried in an oven at 37°C for 1 hour. The obtained surfactant-containing membrane was then processed in the same manner as in step (3) of Comparative Example 1 to obtain the membrane of the present invention on which the anti-DD antibody was immobilized.

[0150] (2) Manufacture of the immunochromatographic device of the present invention

[0151] In the same manner as in step (5) of comparative example 1, the t...

Embodiment 2

[0152] Example 2: Verification of the effect of preventing poor flow progression of test samples exhibited by the porous solid phase for binding assays according to the present invention [1]

[0153] (1) Preparation of model whole blood with high Ht value

[0154] Whole blood was centrifuged to obtain a blood cell layer. Plasma obtained from the same whole blood was added to the blood cell layer to obtain model whole blood with an Ht value of 70%.

[0155] (2) Test method

[0156] 100 μl of model whole blood was applied to the sample pad of the test strip of the device according to the invention manufactured in Example 1, and after 15 minutes, it was checked with the naked eye whether the purple-red line originating from the conjugate and indicating the edge of the advancing liquid Access to the absorbent located at one end of the test strip. If the magenta line had reached the absorber at one end of the test strip, it was judged that the porous solid phase had prevented th...

Embodiment 3

[0162] Example 3: Verification of the effect of preventing poor flow progression of test samples exhibited by the porous solid phase for binding assays according to the present invention [2]

[0163] (1) Preparation of model whole blood with high Ht value (DD model whole blood) containing purified D-dimer (DD)

[0164] Whole blood was centrifuged to obtain a blood cell layer. 10 mmol / l Tris-HCl buffer (pH 8.0) containing purified DD and plasma obtained from the same whole blood was added to the blood cell layer to obtain DD with a final concentration of 1.0 μg / ml after reconstitution and Ht values 70% model whole blood.

[0165] (2) Test method

[0166] 100 μl of DD model whole blood was applied to the sample pad of the immunochromatographic device comprising the porous solid phase for binding assay (containing n-octyl-β-D-glucoside) of the present invention manufactured in Example 1, and at intervals of 1 minute (from 1 minute to 15 minutes after adding the sample) by usin...

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Abstract

Disclosed are: a porous solid phase for use in a binding assay method, which enables the analysis of a sample of interest (e.g., whole blood) rapidly, conveniently, accurately and at low cost without the need of any specific pretreatment procedure after the collection of the sample; and a binding assay method using the porous solid phase. Specifically disclosed are: a porous solid phase for use in a binding assay, which is characterized in that at least one surfactant selected from the group consisting of the following surfactants (A) to (C) is added to the porous solid phase before a sample to be measured is added to the porous solid phase: (A) a sugar-containing surfactant comprising a compound represented by general formula (I), (B) a sugar-containing surfactant comprising a sucrose fatty acid ester in which a fatty acid component has 5 to 14 carbon atoms, and (C) a steroid-type surfactant.

Description

technical field [0001] The present invention relates to an improved porous solid phase for binding assays that prevents the problems of poor flow progression of test samples, poor sensitivity and disturbances in the measurement waveform associated with binding assays in which porosity A solid phase (eg, a membrane) is used to detect test sample components. The invention also relates to binding assays using said porous solid phase. More specifically, the present invention provides a porous solid phase for binding assays (porous solid phase for binding assays) into which at least one surfactant has been incorporated prior to addition of a test sample. agent, the at least one surfactant is selected from the group consisting of: (A) sugar-containing surfactants comprising compounds represented by general formula (I), (B) sugar-containing surfactants, Comprising sucrose fatty acid ester, wherein constituent fatty acids have 5 to 14 carbon atoms, and (C) a steroid surfactant, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543
CPCG01N33/54393G01N33/538G01N33/543
Inventor 吉水美和子近藤万友美丹野真志
Owner SEKISUI MEDICAL CO LTD
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