Method for control or calibration in a chemical analytical determination

• US 5,308,767 A
• Filed: 07/20/1992
• Issued: 05/03/1994
• Est. Priority Date: 10/31/1986
• Status: Expired due to Term

• Current Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Original Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Inventors: Terashima, Masaaki
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): BHAT, NINA NMN
• Application Number:
  US07/915,290
• Time in Patent Office: 652 Days
• Field of Search: 436/8, 436/10, 436/12, 436/13, 436/14, 436/15, 436/16, 436/164, 436/169, 436/170, 422/68.1, 422/69, 422/56, 422/57
• US Class Current: 436/12
• CPC Class Codes: G01N 2496/10 containing particles to mimic blood cells
• CPC Class Codes: G01N 2496/25 containing added polymers to stabilise biological material against degradation or mantain viscosity or density, e.g. gelatin, polyacrylamides, polyvinyl alcohol casein G01N2333/4731, albumins G01N2333/76, polysaccharides G01N2400/10
• CPC Class Codes: G01N 2496/30 Polyethylene glycol, e.g. PEG
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• 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 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control

Abstract

A method for control or calibration in a chemical analytical determination using a dry analysis element comprising at least one color-producing reagent and a porous layer, wherein the method comprises applying an aqueous dispersion onto the porous layer and measuring the optical density of the color produced, wherein the aqueous dispersion comprises a substance which is the same as or similar to an analyte to be determined and water-insoluble particles dispersed therein, wherein the particles are particles of a homopolymer, a copolymer, phthalates, trimellitates, phosphates, benzoates, amides, phenols, aliphatic esters, hydrocarbons, halogenated hydrocarbons, adipates, sebacates and natural polymers.

Claims

1. A method for control or calibration in a chemical analytical determination using a dry analysis element, said dry analysis element comprising at least one color-producing reagent and a porous layer, comprising the steps of:

applying an aqueous dispersion onto the porous layer; and

measuring optical density of the color produced,

wherein the aqueous dispersion comprises a substance which is the same as or similar to an analyte to be determined and water-insoluble particles dispersed therein wherein said water-insoluble particles are solid particles or liquid particles, said solid particles being selected from the group consisting of homopolymers and copolymers and said liquid particles being selected from the group consisting of adipates, sebacates, phthalates, trimellitates, phosphates, benzoates, amides, phenols, aliphatic esters, hydrocarbons, halogenated hydrocarbons, and natural polymers.

2. The method as claimed in claim 1, wherein said water-insoluble dispersed particles are solid particles.

3. The method as claimed in claim 2, wherein said solid particles comprise a homopolymer or copolymer derived from a monomer selected from the group consisting of styrene, an acrylate, vinyl acetate and vinyl chloride.

4. The method as claimed in claim 3, wherein said copolymer is derived from said monomer and a comonomer selected from the group consisting of butadiene, vinyl chloride, acrylamide, acrylic acid and methacrylic acid.

5. The method as claimed in claim 4, wherein said homopolymers and copolymers have a molecular weight of from 10⁵ to 10⁶.

6. The method as claimed in claim 1, wherein said water-insoluble dispersed particles are liquid particles.

7. The method as claimed in claim 6, wherein said liquid particles comprise a compound selected from the group consisting of phthalates, trimellitates, phosphates, benzoates, amides, phenols, aliphatic esters, hydrocarbons and halogenated hydrocarbons.

8. The method as claimed in claim 1, wherein said water-insoluble dispersed particles have a mean particle size of from about 0.01 to about 10 μ

m.

9. The method as claimed in claim 1, wherein said water-insoluble dispersed particles are present in a concentration of about 10 to 50% by weight based on the total weight of the aqueous dispersion.

10. The method as claimed in claim 1, wherein said analyte to be determined comprises a component of whole blood.

11. The method as claimed in claim 1, wherein said analyte to be determined is selected from the group consisting of glucose, urea, uric acid, creatinine, bilirubin, hemoglobin, triglyceride, total cholesterol, NH₄⁺, Ca²⁺, Mg²⁺, HPO₄^2-, SO₄^2-, and NO₃^-.

12. The method as claimed in claim 1, wherein said substance is selected from the group consisting of glucose, urea, uric acid, creatinine, bilirubin, hemoglobin, triolein, glycerine, cholesterol, (NH₄)₂ SO₄, NH₄ Cl, CaCl₂, Ca(NO₃)₂, MgCl₂, NaCl, KCl, K₂ HPO₄, (NH₄)₂ SO₄, Ca(NO₃)₂, and NaNO₃.

13. The method as claimed in claim 1, wherein said water-insoluble dispersed particles have a mean particle size of from 0.05 to 6 μ

m.

14. The method as claimed in claim 1, wherein said water-insoluble dispersed particles have a mean particle size of from 0.2 to 2 μ

m.

15. The method as claimed in claim 1, wherein the dry analysis element comprises paper containing at least one color-producing reagent.

16. The method as claimed in claim 1, wherein the dry analysis element comprises at least one color-producing reagent and a porous spreading layer.

17. The method as claimed in claim 1, wherein the dry analysis element comprises a transparent support having thereon on one side of the support at least one reagent layer comprising at least one color-producing reagent, a light reflecting layer and a porous spreading layer.