Assay kit including an analyte test strip and a color comparator

• US 4,877,580 A
• Filed: 02/09/1988
• Issued: 10/31/1989
• Est. Priority Date: 02/09/1988
• Status: Expired due to Term

• Current Assignee: Home Diagnostics Incorporated, Technimed Corporation
• Original Assignee: Technimed Corporation
• Inventors: Aronowitz, Jack L., Terminiello, Louis
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/153,967
• Time in Patent Office: 630 Days
• Field of Search: 422/56-61, 422/86, 422/87, 435/14, 436/8-19
• US Class Current: 422/401
• CPC Class Codes: G01N 21/293 with colour charts, graduated scales or turrets
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

Abstract

An assay kit comprising an analyte test strip and a color comparator including a plurality of different color fields arranged in an ordered, preferably linear, succession. There is an aperture through each color field so positioned that the reaction zone of the test strip can be placed behind each color field and the color of the reaction zone thereafter viewed through each aperture, with the particular color field framing at least a portion of the reaction zone. The color comparator can be in the form of overlapping panels of a folder or a label on a bottle. There may be a chart of numerical assay values of the color fields such that the edge of the testing strip underlies the numerical value of the color field being viewed, or the testing strip may have a window therein which frames the numerical value of the color field being viewed. This invention has application in test kits for biological substances, (i.e. glucose, cholesterol) and drugs of abuse; and, in test kits for environmental toxins.

Claims

1. A test means comprising:

(a) a test strip which includes an inert support and a sample receptive medium comprising a dry chemistry reagent system specific for an analyte of interest which upon interaction with said analyte produces a characteristic color indicative of an assay value of said analyte of interest, said receptive medium being positioned on said test strip so as to be bordered on one or more sides by said inert support;

(b) a color comparator including a plurality of different color fields representing a range of assay values of said analyte physically arranged in a predetermined ordered succession for comparison with the color of the sample receptive medium of the test strip, each of said color fields having an aperture which permits viewing therethrough of at least a portion of a reaction zone of the sample receptive medium after said analyte has reacted to produce a color therein, and

(c) means for positioning said test strip relative to the aperture of each of said color fields so as to mask from view the inert support which borders the reaction zone of the sample receptive medium.

2. The test means defined in claim 1, wherein said color fields are on a folder of sheet material including a back panel and a closely-spaced front panel, and said means for positioning said test strip include said closely spaced front and back panels of said sheet material and adhesive-free space therebetween.

3. The test means defined in claim 1, including a container having a flat side and a label wrapped around and adhered to the outside surface of said container, said label having an overlapping panel on one side thereof, and wherein said color fields are on said overlapping panel and the means for positioning the test strip includes said overlapping panel, the overlapped portion of said label and adhesive-free space therebetween.

4. The test means defined in claim 1, including a numerical scale printed adjacent said color fields in a position such that said test strip identifies the numerical assay value of each color field when sample receptive medium is viewed through each said aperture.

5. The test means defined in claim 4, wherein the assay values are upwardly offset from their respective color fields such that an edge of said test strip underlines the correct assay value in said scale when the color of said reaction zone is viewed through each of said apertures.

6. The test means defined in claim 4, wherein said assay values are opposite their respective color fields, and said test strip has a window therein so positioned that the correct assay value in said scale is framed by said window when the color of said reaction zone is viewed through each of said apertures.

7. The test means defined in claim 1, wherein said analyte is glucose or cholesterol.

8. A test means comprising an analyte test strip having an analyte reaction zone and a color comparator therefor, said color comparator comprising a plurality of color fields physically arranged in a linear succession, each successive field connoting a different numerical assay value of said analyte, characterized in that each color field has an aperture therethrough entirely framed by said color field, each aperture permitting at least a portion of said reaction zone to be viewed when said reaction zone is positioned behind the color field framing that aperture.

9. The test means defined in claim 8, wherein said test strip includes a bibulous sample receptive medium attached to said strip near one end thereof, said medium containing a dry chemistry reagent system which produce a definitive set of colors in said medium in the presence of detectable quantities of a particular analyte.

10. The test means defined in claim 9, wherein said color comparator includes a back panel of sheet material and an overlapping front panel closely spaced from said back panel, said front panel having a distal edge and carrying said color fields along said distal edge thereof, said test strip being adapted to be slid between said panels into positions whereby said reaction zone can be framed by said apertures.

11. The test means defined in claim 10, including a scale of numerical values corresponding to said color fields and located on said back panel in such positions that each value is identified by said strip when said reaction zone is viewable through each said aperture.

12. The test means defined in claim 11, wherein said numerical value is underlined by the edge of said strip.

13. The test means defined in claim 11, wherein said numerical value is framed by a window in said strip.

14. A test means comprising:

(a) test strip which includes an inert support and a sample receptive medium comprising a dry chemistry reagent system specific for an analyte of interest which upon interaction with said analyte produces a characteristic color indicative of an assay value of said analyte of interest, said receptive medium being positioned on said test strip so as to be bordered on one or more sides by said inert support;

(b) a color comparator comprising a folder having a back panel, a closely-spaced front panel, and an adhesive-free space therebetween, said front panel, including a plurality of different color fields representing a range of assay values physically arranged in a predetermined ordered succession for comparison with the color of the sample receptive medium of the test strip, each successive field connoting a different numerical assay value, each of said color fields having an aperture which permits viewing therethrough of at least a portion of a reaction zone of the sample receptive medium after said analyte has reacted to produce a color therein; and

(c) means for positioning said test strip between said front panel and said back panel and relative to the aperture of each of said color fields so as to mask from view the inert support which borders the reaction zone of the sample receptive medium.

15. A test means comprising:

(a) a test strip which includes an inert support and a sample receptive medium comprising a dry chemistry reagent system specific for an analyte of interest which upon interaction with said analyte produces a characteristic color indicative of an assay value of said analyte of interest, said receptive medium being positioned on said test strip so as to be bordered on one or more sides by said inert support;

(b) a container and a label wrapped around and adhered to the outside surface of said container, said label having a distal panel on one side thereof overlapping a proximal panel on the other side thereof, and an adhesive-free space therebetween,

(c) a color comparator, comprising said overlapping distal panel and said overlapped proximal panel, said overlapping distal panel including a plurality of different color fields representing a range of assay values physically arranged in a predetermined ordered succession for comparison with the color of the sample receptive medium of the test strip, each successive field connoting a different numerical assay value, each of said color fields having an aperture which permits viewing therethrough of at least a portion of a reaction zone of the sample receptive medium after said analyte has reacted to produce a color therein; and

(d) means for positioning said test strip between said distal panel and said proximal panel and relative to the aperture of each of said color fields so as to mask from view the inert support which borders the reaction zone of the sample receptive medium.