Viability test device

• US 4,683,209 A
• Filed: 07/21/1986
• Issued: 07/28/1987
• Est. Priority Date: 02/26/1985
• Status: Expired due to Fees

• Current Assignee: Miles Laboratories, Inc. (Bayer AG)
• Original Assignee: Miles Laboratories, Inc. (Bayer AG)
• Inventors: Hemmes, Paul, Zipp, Adam, Ismail, Ibrahim A., Skarstedt, Mark T.
• Primary Examiner(s): Kyle, Deborah L.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/887,723
• Time in Patent Office: 372 Days
• Field of Search: 435/14, 436/8-18
• US Class Current: 436/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 21/81 Indicating humidity
• 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
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control

Abstract

A viability test device wherein the viability of a test composition for the determination of an analyte of interest can be determined by simply wetting the device with ordinary water. The viability device can be prepared in three formats: a control or calibrator device, an internal control device and a self indicating device. Unreacted analyte, or an analog thereof, can be incorporated in a limited defined portion of a dried carrier matrix incorporated with a test composition to provide an internal control test device. When wetted with water, a positive optical response, usually color, indicates the test composition can provide a viable test for the analyte. The internal control test device is particularly advantageously used by diabetics in their own homes where a negative test response could be due to the desired control of the user'"'"'s condition or due to deterioration of a test composition because of unfavorable storage conditions.

Claims

1. A method for preparing a viability test device, comprising the sequential steps of:

(a) incorporating a carrier matrix substantially uniformly with a test composition which test composition is capable of providing a detectable optical response upon wetting of the test composition incorporated carrier matrix with water in the presence of the analyte to be determined;

(b) drying;

(c) incorporating at least a portion of the dried carrier matrix with a solution of unreacted analyte, or analog thereof, in a dried non-aqueous solvent at a analyte concentration sufficient to provide a detectable optical response in the doubly incorporated carrier matrix upon wetting of the matrix with water; and

(d) drying.

2. A method for preparing a viability test device, comprising the sequential steps of:

(a) incorporating a carrier matrix substantially uniformly with a test composition which test composition is capable of providing a detectable optical response upon wetting of the test composition incorporated carrier matrix with water in the presence of the analyte to be determined;

(b) drying;

(c) incorporating at least a portion of the dried carrier matrix with a suspension of finely divided particles of unreacted analyte, or analog thereof, in a dried non-aqueous solvent; and

(d) drying.

3. A method for preparing an internal control test device comprising the steps of:

(a) incorporating a carrier matrix substantially uniformly with a test composition which test composition is capable of providing a detectable optical response upon wetting of the test composition incorporated carrier matrix with water in the presence of the analyte to be determined;

(b) drying;

(c) incorporating a limited defined portion of the dried carrier matrix with a solution of unreacted analyte, or analog thereof, in a dried non-aqueous solvent at an analyte concentration sufficient to provide a detectable optical response in the doubly incorporated carrier matrix upon wetting of the matrix with water; and

(d) drying.

4. The method of claim 3 in which the incorporated analyte is chosen from a mixture of α

-and β

-D-glucose, β

-D-glucose or an analog of D-glucose, and which dried nonaqueous solvent used is capable of dissolving and maintaining D-glucose in the β

form or capable of supporting mutarotation of D-glucose to the β

form.

5. The method of claim 4 in which the solvent is chosen from dimethylformamide, pyridine, 2-methoxyethanol and methoxy-2-propanol.

6. A method for preparing internal control test device comprising the steps of:

(a) incorporating a carrier matrix substantially uniformly with a test composition, which test composition is capable of providing a detectable optical response upon wetting of the test composition incorporated carrier matrix with water in the presence of the analyte to be determined;

(b) drying;

(c) incorporating a limited defined portion of the dried carrier matrix with a suspension of finely divided particles of unreacted analyte, or analog thereof, in a dried nonaqueous solvent at an analyte concentration sufficient to provide a detectable optical response in the doubly incorporated carrier matrix upon wetting of the matrix with water; and

(d) drying.