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Assay device

An analysis device and analyte technology, applied in the direction of measuring devices, analysis materials, material inspection products, etc., can solve problems that have not been recognized

Inactive Publication Date: 2010-03-03
INVERNESS SWITZERLAND GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These issues do not appear to have been previously recognized in the prior art

Method used

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Examples

Experimental program
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Embodiment 1

[0156] An analytical device was prepared in a manner similar to Comparative Example 1, except that the first and second detection zones were provided on the first and second test strips, respectively, wherein the first and second detection zones were provided On nitrocellulose, each test strip contained a glass fiber provided upstream of the nitrocellulose, sprayed with a removable latex-labeled α-hCG antibody. The first and second detection zones are each provided at 16 mm on the nitrocellulose test strip.

[0157] run test strip

[0158] The test strips of Example 1 and Comparative Example 1 were tested using an in-house reader with calibrated hCG buffer standards at concentrations of 0, 25, 50, 100, 250, 500, 1000, 2500, 5000, 10000, 15000, 20000, 25000, 50000, 150000, 200000 and 250000 mIU / ml hCG.

[0159] Signal intensities measured in the inhibition detection zone as a function of the assayed hCG concentration for Example 1 (indicated by -- ◆--) and Comparative Example...

Embodiment 2

[0161] Example 2 - Contains the first test strip containing the first sandwich assay and except the sandwich Preparation of an analytical device for a second test strip containing a scavenger reagent in addition to the assay

[0162] Preparation of the first analytical test strip

[0163] The first analytical test strip was prepared as in Example 1 for the first (sandwich) analytical test strip.

[0164] Preparation of Second Analytical (Scavenger) Test Strips

[0165] Using the preparation of the first analytical test strip according to Example 2, the detection zone was prepared on nitrocellulose.

[0166] Mouse anti-human α-hCG mAb (clone 3299) and 3 mg / ml scavenger antibody mAb mouse anti-human β-hCG antibody (own clone 3468) conjugated to 400 nm blue polystyrene latex (Duke Scientific) Mixing was performed to give a final % blue latex of 3%, a final 3468 concentration of 0.075 mg / ml, and a free anti-β-hCG antibody concentration of 0.06 mg / ml. The resulting mixture...

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Abstract

Disclosed is an assay device for the determination of the presence and / or extent if an analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole detection zone capable of immobilising a labelled binding reagent and the second assay for said analyte comprises a secondflow- path having a sole detection zone capable of immobilising a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and / or extent of analyte in said liquid sample.

Description

technical field [0001] The present invention relates to analytical devices, kits and methods for determining the presence or extent of an analyte over an extended concentration range. Background of the invention [0002] For the detection of analytes in fluid samples, simple lateral flow immunoassay devices have been developed and commercialized, see eg EP291194. Such devices generally comprise a porous carrier containing dry, mobile, labeled binding reagents capable of binding the analyte of interest, and the immobilized binding reagents are also capable of binding the analyte provided in the detection zone downstream of the labeled binding reagent. thing. Detection of the immobilized, labeled binding at the detection zone provides an indication of the presence of the analyte in the sample. [0003] Alternatively, when the analyte of interest is a hapten, the immunoassay device may utilize a competition reaction in which a labeled analyte or analyte analog competes with t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558G01N33/68
CPCG01N33/558G01N33/689
Inventor 巴比尔·拉伊沙伊·伊彭埃兹拉·林利
Owner INVERNESS SWITZERLAND GMBH