Method for selectively combining multiple membranes for assembly into test strips
First Claim
1. A method for selectively combining multiple membranes for assembly into test strips comprising:
- measuring a plurality of color parameters associated with membrane samples from at least a first lot of membranes and a second lot of membranes;
simulating response characteristics of a speculative test strip that includes, for purposes of simulating the response characteristics, combined multiple membranes tentatively selected from the at least first lot of membranes and second lot of membranes, the simulated response characteristics being based on the measured plurality of color parameters of the tentative selection of combined multiple membranes,wherein the simulated response characteristics are also based on simulated color response data and are obtained utilizing an experimentally-derived multivariate mixed model equation of the form;
R=Yβ
+Zγ
+e
where;
R is an N×
1 vector of color parameter responses;
β
is a b×
1 vector of fixed effect coefficients;
Y is an N×
b matrix of independent covariates;
γ
is a g×
1 vector of random effect coefficients;
Z is an N×
g matrix of random effects; and
e is a N×
l vector of residual errors; and
assembling the at least first and second lot of membranes from which the combined multiple membranes were tentatively selected into a test strip with combined membranes, the assembly contingent on an assessment of acceptable test strip clinical accuracy based on the simulated response characteristics.
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Abstract
A method for selectively combining multiple membranes for assembly into test strips (such as visual blood glucose test strips with side-by-side membranes). The method includes first measuring a plurality of color parameters (e.g., L*, a* and b*color parameters) associated with membrane samples from at least two membrane lots. Next, response characteristics (e.g., blood glucose response levels) are simulated for a speculative test strip that includes, for purposes of the simulation, combined multiple membranes tentatively selected from the at least two membrane lots. The simulated response characteristics are based on the measured plurality of color parameters of the tentative selection of combined multiple membranes. Optionally, the simulated response characteristics can also be based on simulated color parameters of the tentative selection of combined multiple membranes. Subsequently, assembly of the at least two membrane lots into a test strip with combined membranes is contingent on acceptable simulated response characteristics. Any suitable color parameters can be employed. The method can be used to selectively combine two or more membranes based on any number of color parameters. The assembled test strips can be used to measure glucose, cholesterol, proteins, ketones, phenylalanine or enzymes in blood, urine, saliva or other biological fluid, as well as sample fluid characteristics (e.g., pH and alkalinity).
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Citations
16 Claims
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1. A method for selectively combining multiple membranes for assembly into test strips comprising:
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measuring a plurality of color parameters associated with membrane samples from at least a first lot of membranes and a second lot of membranes; simulating response characteristics of a speculative test strip that includes, for purposes of simulating the response characteristics, combined multiple membranes tentatively selected from the at least first lot of membranes and second lot of membranes, the simulated response characteristics being based on the measured plurality of color parameters of the tentative selection of combined multiple membranes, wherein the simulated response characteristics are also based on simulated color response data and are obtained utilizing an experimentally-derived multivariate mixed model equation of the form;
R=Yβ
+Zγ
+e
where;R is an N×
1 vector of color parameter responses;β
is a b×
1 vector of fixed effect coefficients;Y is an N×
b matrix of independent covariates;γ
is a g×
1 vector of random effect coefficients;Z is an N×
g matrix of random effects; ande is a N×
l vector of residual errors; andassembling the at least first and second lot of membranes from which the combined multiple membranes were tentatively selected into a test strip with combined membranes, the assembly contingent on an assessment of acceptable test strip clinical accuracy based on the simulated response characteristics. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for selectively combining multiple membranes for assembly into visual test strips, the visual test strips for use in determination of analyte concentration in a biological fluid, the method comprising:
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measuring L*, a* and b*color parameters, Commission of the Internationale de L'"'"'Eclairage, associated with membrane samples from at least a first lot of membranes and a second lot of membranes; obtaining simulated color parameters associated with the membrane samples selected from at least the first lot of membranes and the second lot of membranes; simulating response characteristics of a speculative test strip that includes, for purposes of simulating the response characteristics, combined multiple membranes tentatively selected from the at least first lot of membranes and second lot of membranes, the simulated response characteristics being based on the measured plurality of color parameters and the simulated color parameters of the tentative selection of combined multiple membranes, wherein the simulated response characteristics are also based on simulated color response data and are obtained utilizing an experimentally-derived multivariate mixed model equation of the form;
R=Yβ
+Zγ
+e
where;R is an N×
1 vector of color parameter responses;β
is a b×
1 vector of fixed effect coefficients;Y is an N×
b matrix of independent covariates;γ
is a g×
1 vector of random effect coefficients;Z is an N×
g matrix of random effects; ande is a N×
l vector of residual errors; andassembling the at least first and second lot of membranes into a test strip with combined membranes contingent on an assessment of acceptable test strip clinical accuracy based on the simulated response characteristics. - View Dependent Claims (14, 15, 16)
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Specification