System for determining the concentration of components of body fluids

• US 4,852,025 A
• Filed: 02/11/1987
• Issued: 07/25/1989
• Est. Priority Date: 05/22/1986
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Herpichbohm, Bernd
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Mattson, Brian M.
• Application Number:
  US07/013,396
• Time in Patent Office: 895 Days
• Field of Search: 364/413, 364/415-417, 364/497-499, 364/550, 364/551, 364/555, 364/551.01, 364/413.18, 364/413.22, 364/413.07-413.09, 364/413.11, 128/632, 128/633, 128/637, 356/39, 356/436
• US Class Current: 702/19
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The disclosed system determines the concentration of components of body fluids using test carriers and an instrument to evaluate the test carriers. The instrument has an electronic evaluating system with a processor which, on the basis of information transmitted to it concerning the batch-specific evaluation curve of the particular test carrier batch used, calculates the concentration (C) from a value (R) measured on the test carrier. The information about the evaluation curve is contained in visible indicia printed on each test carrier itself or on material for packaging, or packaged with, multiple test carriers.

Claims

1. In a plurality of test carriers for use in a system for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), said test carriers having been manufactured in batches, each of said test carriers comprising a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) is dependence upon said concentration of said constituent in said body fluid, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of the test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

the improvement comprising;

a plurality of visible indicia disposed on each of said test carriers and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof,

each calculation supporting point being indicative of said dependence between said measurable physical quantity and said concentration in the respective region for the respective test carrier.

2. The improvement defined in claim 1, wherein said visible indicia are printed on said test carrier base.

6. The improvement defined in claim 1, 4 or 5, wherein each of said visible indicia identifies a particular calculation supporting point from among sets of points each set consisting of a finite number of prescribed calculation supporting points;

each calculation supporting point comprising an associated coordinate value pair of said measurable physical quantity (R) and its associated body fluid constituent concentration (C) in an R-C coordinate plane;

each set of calculation supporting points being located, respectively, in one of said regions of said ends and said at least one point of inflection of said curve on said R-C plane.

7. The improvement defined in claim 6, wherein said prescribed calculation supporting points in each set have different distances from the dependence between said physical quantity and said concentration for the respective test carrier, and wherein said calculation supporting points identified by said indicia are those points within said sets which are at least next to the closest to the dependence between said physical quantity and said concentration in the respective test carrier.

8. The improvement defined in claim 1, 4 or 5, wherein said visible indicia are alphanumeric characters.

9. The improvement defined in claim 8, wherein said visible indicia comprise a maximum of ten alphanumeric characters.

10. The improvement defined in claim 9, wherein said visible indicia comprise a maximum of five alphanumeric characters.

11. The improvement defined in claim 10, wherein said visible indicia comprise three alphanumeric characters.

12. The improvement defined in claim 8, wherein each visible indicium comprises one of a maximum of sixteen alphanumeric characters.

3. In a system for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), said system comprising (1) a plurality of test carriers having a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, and (2) evaluating apparatus having a digital processor and a memory for determining said concentration from said physical quantity, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of said test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

the improvement comprising;

a plurality of visible indicia disposed on each of said test carriers and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof;

each calculation supporting point being indicative of said dependence between said physical quantity and said concentration in the respective region for the respective test carrier;

said evaluating apparatus comprising means for manually entering said visible indicia into said memory.

4. In a plurality of test carriers for use in a system for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), said test carriers having been manufactured in batches, each of said test carriers comprising a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of the test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection therebetween, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

wherein a plurality of said test carriers which are manufactured together in a single batch are enclosed together in a common package;

the improvement comprising;

a plurality of visible indicia disposed on said package and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof,

each calculation supporting point being indicative of said dependence between said measurable physical quantity and said concentration in the respective region for the respective test carrier.

5. In a plurality of test carriers for use in a system for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), said test carriers having been manufactured in batches, each of said test carriers comprising a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity in dependence upon said concentration of said constituent in said body fluid, said dependence between said physical quantity (R) and said concentration being different from manufactured batch to manufactured batch of the test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection therebetween, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

wherein a plurality of said test carriers which are manufactured together in a single batch are enclosed together in a common package, together with a separate, removable record medium wrapped with said test carriers in said common package;

the improvement comprising;

a plurality of visible indicia disposed on said separate record medium and representing calculation supporting points for said curve in the region of at least one of said ends and said at lest one point of inflection thereof;

each calculation supporting point being indicative of said dependence between said measurable physical quantity and said concentration in the respective region for the respective test carrier.

13. In a system for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), said system comprising (1) a plurality of test carriers having a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, and (2) apparatus having a digital processor and a memory for determining said concentration from said physical quantity, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of said test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection therebetween, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

wherein a plurality of said test carriers which are manufactured together in a single batch are enclosed together in a common package;

the improvement comprising;

a plurality of visible indicia disposed on said package and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof;

each calculation supporting point being indicative of said dependence between said physical quantity and said concentration in the respective region for the respective test carrier;

said evaluating apparatus comprising means for manually entering said indicia into said memory.

15. The improvement defined in claim 3, 13 or 14, wherein each of said visible indicia identifies a particular calculation supporting point from among sets of points, each set consisting of a finite number of prescribed calculation supporting points;

each calculation supporting point comprising an associated coordinate value pair of said measurable physical quantity (R) and its associated, body fluid constituent concentration (C) in an R-C coordinate plane;

each set of calculation supporting points being located, respectively, in one of said regions of said ends and said at least one point of inflection of said curve on said R-C plane.

16. The improvement defined in claim 15, wherein said prescribed calculation supporting points in each set having different distances on the R-C plane from the dependence between said physical quantity and said concentration for the respective test carrier, and wherein said calculation supporting points identified by said indicia are those points within said sets which are at least next to the closest to the dependence between said physical quantity and said concentration in the respective test carrier.

17. The system defined in claim 3, 13 or 14, wherein said indicia entry means includes a plurality of keys.

14. In a system for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), said system comprising (1) a plurality of test carriers having a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, and (2) apparatus having a digital processor and a memory for determining said concentration from said physical quantity, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of said test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection therebetween, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

wherein a plurality of said test carriers which are manufactured together in a single batch are enclosed together in a common package, together with a separate, removable record medium wrapped with said test carriers in said common package;

the improvement comprising;

a plurality of visible indicia disposed on said separate record medium and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof;

each calculation supporting point being indicative of said dependence between said physical quantity and said concentration in the respective region for the respective test carrier;

said evaluating apparatus comprising means for manually entering said indicia into said memory.

18. A method of analyzing a constituent of a body fluid which is present in said fluid in a given concentration (C), using a system comprising (1) a plurality of test carriers having a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, (2) evaluating apparatus having a digital processor and a memory for determining said concentration from said physical quantity, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of said test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection, each of said ends and said at least one point of inflection defining a region immediately surrounding it, and (3) a plurality of visible indicia disposed on each of said test carriers and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof, each calculation supporting point being indicative of said dependence between said physical quantity and said concentration in the respective region for the respective test carrier, said evaluating apparatus comprising means for manually entering said visible indicia into said memory;

said method comprising the steps of;

(a) applying a body fluid to a test carrier;

(b) manually reading said visible indicia for a test carrier to be evaluated;

(c) manually entering said visible indicia into said evaluating apparatus by means of said entry means; and

(d) evaluating said test carrier by means of said evaluating apparatus to determine the concentration of said constituent of said body fluid applied to said test carrier.

19. A method for analyzing a constituent of a body fluid which is present in said fluid in a given concentration (c), said body fluid being applied to a test carrier and said method using apparatus for evaluating said test carrier;

said evaluating apparatus including means for measuring a physical quantity (R) on a test carrier as a measure of said concentration (C) of said body fluid constituent to be determined;

said test carrier being one of a plurality of test carriers which have been manufactured in batches;

the physical quantity (R) and the concentration (C) defining an evaluation curve of said test carrier, which is different, depending upon the manufacturing batch of said test carrier;

said method for determining the concentration (C) from the measured physical quantity (R) comprising the following steps;

(a) storing a standard evaluation curve in a memory, said standard curve being similar to that of the evaluation curves of the test carriers which are to be evaluated by said evaluating apparatus, said standard curve extending within a range of concentration values of said evaluation curves and having a substantially similar curvature in substantially the same sections of concentrations as said actual evaluation cures, thereby defining a plurality of standard concentration values (C_sx), said standard curve and said actual evaluation curves having two ends and at least one point of inflection therebetween;

each of said ends and said at least one point of inflection defining a region immediately surrounding it and defining sections between said regions;

(b) defining a standard supporting point, comprising an R value and a C value (R_sa, C_sa ;

R_sb, C_sb ;

. . . ) on said standard curve in the region of each of said at least one point of inflection between a curved section and in the region of said range of values to be determined;

(c) storing a plurality of calculation supporting points, arranged in a plurality of sets, each particular set of calculation supporting points lying in said region of a standard supporting point and being assigned to such standard supporting points;

(d) selecting calculation supporting points, one from each set, from said sets of calculation supporting points;

(e) measuring the physical quantity (R) on a test carrier;

(f) converting the measured physical quantity (R) by an approximation procedure into a standard physical quantity (R_sx) on said standard evaluation curve, taking into consideration relative magnitudes of a distance between two R values (R_ia, R_ib) of the nearest calculation supporting point and a second distance between two R values (R_sa, R_sb) of the standard supporting points, to which the calculation supporting points are assigned; and

(g) converting the standard concentration value (C_sx) on said standard evaluation curve, corresponding to said standard measured value (R_sx), into a final concentration value (C_ix) to be determined, taking into consideration the relative magnitude of the distance between the two concentration values (C_ia, C_ib) of a nearest calculation supporting point, and the distance between the two concentration values (C_sa, C_sb), to which the calculation supporting points are assigned.

20. The method of claim 19, wherein said standard measured value R_sx is calculated by the linear approximation ##EQU3## and said final concentration value is calculated by the linear approximation ##EQU4##

21. The method defined in claim 19, wherein each of said sets of calculation supporting points in the vicinity of a standard supporting point lie on an approximately straight line which intersects the standard curve at an obtuse angle.

22. The method defined in claim 19, wherein each of said set of calculation supporting points lie on a straight line which runs parallel to a coordinate of the R-C coordinate plane.

23. The method defined in claim 19, wherein step (c) includes the step of storing at least two, and at most five set of calculation supporting points.

24. A method of analyzing the presence of a constituent of a body fluid which is present in said fluid in a given concentration (c), using a system comprising (1) a plurality of test carriers having a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, and (2) apparatus having a digital processor and a memory for determining said concentration from said physical quantity, said dependence between said physical quantity and said concentration being different from manufactured batch to manufactured batch of said test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection therebetween, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

wherein a plurality of said test carriers which are manufactured together in a single batch are enclosed together in a common package;

wherein a plurality of visible indicia are disposed on said package and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof;

each calculation supporting point being indicative of said dependence between said physical quantity and said concentration in the respective region for the respective test carrier; and

wherein said evaluating apparatus comprises means for manually entering said indicia into said memory;

said method comprising the steps of;

(a) applying a body fluid to a test carrier;

(b) manually reading said visible indicia for a test carrier to be evaluated;

(c) manually entering said visible indicia into said evaluating apparatus by means of said entry means; and

(d) evaluating said test carrier by means of said evaluating apparatus to determine the concentration of said constituent of said body fluid applied to said test carrier.

25. A method of analyzing the presence of a constituent of a body fluid which is present in said fluid in a given concentration (c), using a system comprising (1) a plurality of test carriers having a base and a test field arranged on said base and impregnated with at least one reagent which reacts with said constituent when said body fluid is applied thereto to produce a measurable physical quantity (R) in dependence upon said concentration of said constituent in said body fluid, and (2) apparatus having a digital processor and a memory for determining said concentration from said physical quantity, said dependence between said physical quantity and said concentration being difference from manufactured batch to manufactured batch of said test carriers, but substantially following a standard, predictable, non-linear curve having two ends and at least one point of inflection therebetween, each of said ends and said at least one point of inflection defining a region immediately surrounding it;

wherein a plurality of said test carriers which are manufactured together in a single batch are enclosed together in a common package, together with a separate, removable record medium wrapped with said test carriers in said common package;

wherein a plurality of visible indicia disposed on said separate record medium and representing calculation supporting points for said curve in the region of at least one of said ends and said at least one point of inflection thereof;

each calculation supporting point being indicative of said dependence between said physical quantity and said concentration in the respective region for the respective test carrier; and

wherein said evaluating apparatus comprising means for manually entering said indicia into said memory;

said method comprising the steps of;

(a) applying a body fluid to a test carrier;

(b) manually reading said visible indicia for a test carrier to be evaluated;

(c) manually entering said visible indicia into said evaluating apparatus by means of said entry means; and

(d) evaluating said test carrier by means of said evaluating apparatus to determine the concentration of said constituent of said body fluid applied to said test carrier.