Miles Laboratories, Inc.

Adam P Zipp

Paul R Hemmes

Mark T Skarstedt

Ibrahim A Ismail

Richard S Turk

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.

Viability test device

Test means, method for making same and method for assaying the urea content of fluids such as blood serum, plasma, urine and spinal fluid are disclosed. The preferred method for making the test means involves a three stage application of reagents separated from each other on an acid modified carrier matrix. One reagent is o-phthalaldehyde and the other reagent is 3-hydroxy-1,2,3,4-tetrahydrobenzo[h] quinoline, 3-acetoxy-1,2,3,4-tetrahydrobenzo[h]quinoline or their dihydrochloride salts. Stability of the reagents is achieved and precipitation of serum proteins is avoided. Moreover, the interfering color due to the presence of bilirubin is minimized when the urea content of serum is determined.

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Goshen, IN, United States of America

Adam P Zipp