Test device with novel control symbolism

• US 5,132,085 A
• Filed: 02/28/1991
• Issued: 07/21/1992
• Est. Priority Date: 02/28/1991
• Status: Expired due to Fees

• Current Assignee: Eastman Kodak Company
• Original Assignee: Eastman Kodak Company
• Inventors: Pelanek, Geraldine A.
• Primary Examiner(s): Lacey, David L.
• Assistant Examiner(s): CHAN, KWONG
• Application Number:
  US07/663,239
• Time in Patent Office: 509 Days
• Field of Search: 436/169, 436/170, 436/178, 436/809, 435/293, 435/300, 435/311, 435/288, 422/55-60, 422/102, 422/104
• US Class Current: 422/402
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/56955 involved in periodontal diseases
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays

Abstract

There are described assay devices having a control surface on which controls are deposited to produce a representational symbol that preferably indicates a satisfactory test procedure, or a failure in the test procedure. In one aspect of the invention, the symbol comprises exclusively the positive control areas and the negative control area, so that the negative control area will convert the "satisfactory" symbolism into "unsatisfactory" symbolism. In another aspect, the symbols that are formed are "OK" and "OK", respectively.

Claims

1. In a solid phase assay device for use in a binding assay to determine the presence of an analyte in a liquid sample, the device comprising a plurality of reaction surfaces which comprise at least one of positive control area, a negative control area and a patient sample analyte area, wherein at least one of said reaction surfaces have at least two of said areas taken from any two of said positive control, said negative control and said patient sample analyte combined and configured together so that said two areas produce, in the presence of an appropriate analyte, a representational symbol selected from words and pictures that a) are of a predetermined, connected shape b) are informative of the test result and its validity,

the improvement wherein said at least two areas configured together are the positive and negative controls on one of said reaction surfaces and said symbol is formed so as to be indicative of either of two exclusive alternatives:

that the test device and procedure are operating satisfactorily, or they are not operating satisfactorily,

and further wherein said patient sample analyte area is on another of said reaction surfaces and spaced away from said reaction surface of said two control areas, and wherein said two control areas occupy only the approximate center portion of the reaction surface containing them so that they occupy less than the total area of said reaction surface containing them,

so that false positives are readily distinguished by the user.

2. An assay device as defined in claim 1, wherein said positive control area includes a separate subarea for testing for a plurality of antigens, said subareas being disposed and configured such that when all positive controls for all of the antigens react as expected to each produce part of the representational symbol indicative of satisfactory operation, then the indicative symbol will be complete.

3. An assay device as defined in claim 1 or 2, wherein said negative control area occupies the area of a diagonal slash that is connected to the representational symbol produced by said positive control area.

4. An assay device as defined in claim 3, wherein said representational symbol produced by said positive control area is the symbol "OK".

5. An assay device as defined in claim 3, wherein said representational symbol produced by said positive control area is the symbol "OK", each of said subareas contributing to a portion only of said "OK", so that the failure of any one positive control will prevent the complete formation of the symbol.

6. An assay device as defined in claims 1 or 2, wherein said areas occupied by said positive and negative controls form a facial expression having recognition in more than one language.

7. An assay device as defined in claim 6, wherein said positive control area is configured to produce the eyes and a smile of said facial expression.

8. An assay device as defined in claim 7, wherein said negative control area is configured to convert said smile into a frown, if the negative control area is active to signal a failure in the negative control.

9. An assay device as defined in claim 2, further including periodontal disease antigens.

10. An assay device as defined in claim 9, wherein said antigens comprise the periodontal antigens Aa, Bi and Bg, and said positive control area includes immobilized reagent for each of said periodontal antigens.

11. An assay device as defined in claim 1 or 2, wherein said areas each comprise immobilized binding reagent for a label, said binding reagent for a positive control area being active to bind a label regardless of the presence of the target analyte in the patient sample, said binding reagent for said sample-analyte binding area being effective to bind label only in the presence of said target antigen in the patient sample, and said binding agent in said negative control area being effective to form a visual signal if there is non-specific binding of reagents.

12. An assay device as defined in claim 1, wherein the area occupied by said negative control is such as to produce, in an invalid test, a representational symbol known to be a negation of the representational symbol produced by said area of the positive control.

13. An assay device as defined in claim 12, wherein the area of said negative control is a dot that is under and extends beyond said positive control area, and comprises chemistry that produces a visible dye build-up if the test is invalid.

14. An assay device as defined in claim 12 wherein said negative control area and the resulting representational symbol of negative is one having recognition in more than one language.

15. In a solid phase assay device for use in a binding assay to determine the presence of multiple analytes in a liquid sample, the device comprising a plurality of reaction surfaces which comprise at least one of positive control area, a negative control area and a patient sample-analyte area, at least one of said areas being configured to produce, in the presence of an appropriate analyte, a predetermined connected symbol representing the results of the test;

the improvement wherein said at least one area is configured to produce as a representational symbol of validity, the symbol "OK", and said "OK" symbol is defined by said at least one positive control area in combination with another positive control area for a different analyte than said one positive control area,

and further wherein said patient sample-analyte area is on another of said reaction surfaces and spaced away from said reaction surface of said two control areas, and wherein said two control areas occupy only the approximate center portion of the reaction surface containing them so that they occupy less than the total area of said reaction surface containing them,

so that false positives are readily distinguished by the user.

16. A device as defined in claim 15, wherein another of said two control areas of said reaction surface is effective, if activated to produce a visual indication, to negate said "OK" symbol.

17. A device as defined in claim 16, wherein said another area is said negative control area.

18. In a solid phase assay device for use in a binding assay to determine the presence of an analyte in a liquid sample, the device comprising a plurality of reaction surfaces while comprise at least one of positive control area, a negative control area and a patient sample-analyte area, wherein at least one of said reaction surfaces have at least two of said areas taken from any two of said positive control, said negative control and said patient sample analyte combined and configured together so that said two areas produce, in the presence of an appropriate analyte, a representational symbol selected from words and pictures that area of a predetermined, connected shape and are informative of the test result,

the improvement wherein said at least two areas configured together are the positive and negative controls on one of said reaction surfaces and said symbol is formed so as to be indicative of either of two exclusive alternatives:

that the test device and procedure are operating satisfactorily, or they are not operating satisfactorily,

and wherein said negative control area comprises an antibody specific to the analyte being tested.

19. In a solid phase assay device for use in a binding assay to determine the presence of multiple analytes in a liquid sample, the device comprising at least one reaction surface having at least one positive control area, a negative control area and a patient sample-analyte area, at least one of said areas being configured to produce, in the presence of an appropriate analyte, a predetermined, connected symbol representing the actual results of the test;

the improvement wherein said at least one area is configured to produce the representational symbol "OK", and said "OK" symbol is defined by said at least one positive control area in combination with another positive control area for a different analyte than said one positive control area,

and wherein said negative control area comprises an antibody specific to the analyte being tested.