System for determining the concentration of components of body fluids

Claim 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.

Claim 24

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.

Claim 25

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.

Claim 26

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.

Claim 27

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.

Claim 32

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.

Claim 33

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.

Claim 34

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.

Claim 35

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.