Analytical test device and method

A technology for analyzing assay devices and analytes, applied in measuring devices, analytical materials, biological material analysis, etc., can solve the problems of large amount of labeling, large detection area, increased assay time, etc., and achieve the effect of rapid and effective flow

Inactive Publication Date: 2001-10-17
SPECTRAL DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this requires a larger amount of labeling and a larger area of ​​the detection zone
[0021] If the zone is in the form of a long channel and the zone area is increased by simply increasing the channel length, the result is a substantial increase in assay time as the velocity of the forward moving liquid decreases exponentially along the entire distance being wetted

Method used

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  • Analytical test device and method
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  • Analytical test device and method

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0303] Whole blood CK-MB test

[0304]1A) On a polyester-supported nitrocellulose film (Gerbermenbrane GmbH, Gerbershausen, Germany), paint the contour shown in Figure 4 with Paint Marker 751 Yellow (Edding AG, Ahrensburg, Germany). A capture test line was prepared with 13 mg / ml streptavidin in water (Streptavidin, poly, from Micrsoft GmbH, Benried, Germany). Controls were prepared with 80 μl of a 4% (wt / vol) sucrose solution (from Sigma-Aldrich GmbH, Steinheim, Germany), 10 μl of water, and 10 μl of a 1 mg / ml recombinant CK-MB solution (from Spectral Diagnostics, Toronto, Canada). Test line. After drying, octyl-beta-D-gluco-pyranoside (Octyl-beta-D-Gluco-Pyranoside) (from Sigma-Aldrich GmbH in Steinheim, Germany), 1 : 30 dilutions of Kasein-Bindemittel (from H. Schmineke & Co., Erkrath, Germany) and 30 mM 1,4-piperazinediethanesulfonic acid (from Sigma-Aldrich GmbH, Steinheim, Germany) with a final pH value of 6.2 (blocking) solution to impregnate the ...

example 2

[0309] Comparison of semicircular and rectangular CK-MB assays

[0310] To illustrate the concept of generality, the specimen was brought into a semicircular area (circular section) (Fig. 4 and Figure 5 ) and the specimen enters the rectangular area (ie Figure 9 Compare with side 3) of Figure 10. The assay area (contour area) was the same in both cases. All the steps are the same as in Example 1) except for the outline shape and the direction of blood entry. rCKMB circular part rectangular ng / ml signal assay time signal assay time 0 - 6.5 min - 7.5 min 20 ++ 7.0 min ++ 7.5 min

example 3

[0312] Semi-circular area - 3 analytes - one detection area

[0313] Prepare the assay as in Example 1B), but in addition to having the CKMB antibody capture line, the TNI antibody capture line and the myoglobin antibody capture line.

[0314] TNI capture: 13mg / ml polyclonal goat TNI

[0315] CKMB Capture: lrCKMB-28 at 13mg / ml

[0316] Myoglobin capture: 13mg / ml polyclonal rabbit myoglobin

[0317] All antibodies were from Spectral Diagnostics, Toronto.

[0318] The conjugated alloys corresponding to the 3 analytes were from British BiocellIntern.. from Cardiff, UK:

[0319] TNI-gold-a: 40nm gold sol filled with 8 μg / ml of 81-7 antibody (OD10)

[0320] TNI-gold-b: 40nm gold sol filled with 16μg / ml 21-14 antibody (OD10)

[0321] Myoglobin-gold: 15nm gold sol filled with 90μg / ml 2Mb-295 antibody (OD10)

[0322] CK-MB gold: 40nm gold sol filled with 22μg / ml 5CKMB-6 (OD10)

[0323] All antibodies were from Spectral Diagnostics, Toronto.

[0324] The TNI-gold bindi...

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Abstract

An analytical test device is described for the immunochromatographic determination of the presence of one or more analytes in fluid samples. The device is configured such that the sample is allowed to enter the detection zone simultaneously from many different directions, eliminating stagnation of the flow of the sample. By selection of the porous substrate, the device also allows for the separation of red blood cells from plasma, providing a rapid test for one or more analytes in a sample of whole blood. The device of the present invention may measure more than one analyte simultaneously from a single sample, either by having multiple immunochromatographic pathways fed by a single sample, or multiple analytes detected in the same pathway by way of multiple capture antibodies.

Description

field of invention [0001] The present invention relates to an analytical assay device and method for determining the presence of an analyte in a fluid sample. The devices and methods are particularly useful for determining the presence of cardiac analytes in whole blood, although their application is not limited thereto. Background of the invention [0002] The products and methods of the invention are useful for many diagnostic purposes, as well as for following the course and treatment of mammalian diseases. It is suitable for a variety of mammalian body fluids such as whole blood, serum, plasma and urine. Although the invention is primarily discussed for use in the detection of cardiac analytes, it is also applicable to other fields utilizing antigen / antibody or equivalent reactions. [0003] Numerous related analytical operations, particularly those involving immunoassays, can be performed using the device of the present invention and its disclosed variations. For exa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/543G01N33/548G01N33/558
CPCG01N33/54366Y10S436/811G01N2333/9123G01N2333/4712G01N33/558G01N2333/805Y10T436/25125G01N33/53
Inventor 赫尔穆特·E·弗莱塔格史沁卫查尔斯·A·哈林顿
Owner SPECTRAL DIAGNOSTICS
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