Diagnostic strips

• US 5,871,695 A
• Filed: 12/12/1995
• Issued: 02/16/1999
• Est. Priority Date: 12/12/1995
• Status: Expired due to Fees

• Current Assignee: New Diatech Diagnostic Technology Corporation
• Original Assignee: New Diatech Diagnostic Technology Corporation
• Inventors: Khartchenko, Alina S., Khartchenko, Alissa S., Khartchenko, Nadejda P., Khartchenko, Serguei V.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/571,046
• Time in Patent Office: 1,162 Days
• Field of Search: 422/56, 422/58, 422/61, 436/169
• US Class Current: 422/421
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/728 Bilirubin; including biliverdin

Abstract

A gelatinous reagent containing chloride ions, aliphatic alcohol, Fe³⁺ and trace amounts of selected agents is useful for detecting the pathologies of atherogenic metabolism and bilirubinemia by observation of a color change when the reagent is brought into contact with a body fluid. The reagent can be carried on a diagnostic strip or can be used for spectrometric analysis in liquid form. The reagent can be used with a second reagent containing oxammonium sulfate to identify the pathologies by measurement of the electropotential generated when a body fluid is brought into contact with both of the reagents.

Claims

1. A diagnostic strip carrying a carrier matrix impregnated with a gelatinous reagent for diagnostic determination comprising 0.083 to 0.15% by weight gelatin, about 0.05 to 6.0M chloride ions, about 0.05 to 5.5M aliphatic alcohol, 0.015 to 4.0M Fe³⁺ from a ferric salt and 0.05% to 0.1% calcium, 0.03 to 0.1% sodium, 0.02 to 0.05% potassium, 0.01 to 0.03% , each of nitrate and sulfate, 0.01 to 0.02%, each of phosphate, copper and zinc, 0.003 to 0.005% each of Fe²⁺ and lead;

and 0.0003 to 0.0005% arsenic, all by weight.

2. The diagnostic strip of claim 1 wherein the carrier matrix is formed of paper and the strip is formed of a water insoluble material.

3. The diagnostic strip of claim 1 wherein in the gelatinous reagent the aliphatic alcohol is a polyalcohol selected from the group consisting of glycerol and ethylene glycol and is present at a concentration of 0.05 to 0.1M, the ferric ions are from the addition of ferric chloride hexahydrate and are present at a concentration of 0.93 to 1.83M and the chloride ions are in part from the addition sodium chloride and/or potassium chloride at a concentration of 0.05 to 0.1M.

4. A diagnostic strip carrying a first carrier matrix and a second carrier matrix, the first carrier matrix impregnated with a first gelatinous reagent for diagnostic determination comprising:

0.083 to 0.15% by weight gelatin, about 0.05 to 6.0M chloride ions, about 0.05 to 5.5M aliphatic alcohol, 0.015 to 1.85M Fe³⁺ ions from a ferric salt and 0.05% to 0.1% calcium, 0.03 to 0.1% sodium, 0.02 to 0.05% potassium, 0.01 to 0.03% , each of nitrate and sulfate, 0.01 to 0.02%, each of phosphate, copper and zinc, 0.003 to 0.005% each of Fe²⁺ and lead; and

0.0003 to 0.0005% arsenic, all by weight; and

the second carrier matrix impregnated with a second gelatinous reagent for diagnostic determination comprising 0.083 to 0.15% by weight gelatin, about 3.0 to 4.0M oxammonium sulfate, the first and second carriers being positioned in close proximity on the strip.

5. The diagnostic strip of claim 4 wherein in the first gelatinous reagent the aliphatic alcohol is a polyalcohol selected from the group consisting of glycerol and ethylene glycol and is present at a concentration of 0.05 to 0.1M, the ferric ions are from the addition of ferric chloride hexahydrate and are present at a concentration of 0.93 to 1.83M and the chloride ions are in part from the addition sodium chloride and/or potassium chloride at a concentration of 0.05 to 0.1M.

6. The diagnostic strip of claim 4 wherein the second carrier matrix is positioned on top of the first carrier matrix.