摘要:
Disclosed is a serum free control reagent formulation useful for the determination of a pre-selected analyte. The formulation involves an aqueous solution of a predetermined amount of the analyte together with a polymerized quaternary salt of di- or mono- allyl, di- or tri- alkyl ammonium characterized by the formulae: ##STR1## where R is straight or branched chain alkyl of 1 to 4 carbon atoms, n is a number of at least 9 and .theta. represents a counteranion. The formulation typically contains a buffer to maintain its pH at a level of about 7.5 and a preservative.
摘要:
Disclosed is an improved procedure for the manufacture of a diagnostic test device comprising a matrix having uniformly dispersed a tetrazolium salt and a reagent system designed to convert the tetrazolium to its colored formazan upon contacting the matrix with a fluid containing an analyte whose presence and/or concentration is being sought. The procedure involves applying the tetrazolium salt to the matrix from its solution in an organic solvent and, after drying, applying the reagent system to the matrix from its aqueous solution to which has been added hexanesulfonate as wetting agent.
摘要:
Biological reagent compositions with improved sensitivity to the concentration of blood glucose in patient samples for use in measuring systems and methods. The reagent compositions comprise a glucose oxidoreductase enzyme, a flavin nucleoside coenzyme and a mediator formulation. The mediator formulation comprises at least one electroactive organic molecule and at least one coordination complex.
摘要:
A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.
摘要:
An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.
摘要:
Biological reagent compositions with improved sensitivity to the concentration of blood glucose in patient samples for use in measuring systems and methods. The reagent compositions comprise a glucose oxidoreductase enzyme, a flavin nucleoside coenzyme and a mediator formulation. The mediator formulation comprises at least one electroactive organic molecule and at least one coordination complex.
摘要:
An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.
摘要:
A test strip for measuring an analyte level in a fluid sample includes a sample chamber configured to receive the fluid sample; a plurality of electrodes configured to produce at least one current measurement related to the analyte level in the fluid sample; and at least one information-providing connector having an intrinsic electrical property representative of at least one test strip calibration parameter specific to the test strip. A system for measuring an analyte level in a fluid sample may include such a test strip along with a data acquisition system controlled by a processor and configured to measure an intrinsic electrical property of the information-providing connector and to obtain at least one test strip calibration parameter corresponding to the test strip from at least one predetermined location in a memory based on the intrinsic electrical property.
摘要:
An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.
摘要:
A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber or other testing zone, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the testing zone. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.