Analyte measurement device and method of use
First Claim
1. A test device for insertion into a measurement instrument having an alignment member therein for engagement with said test device, said test device comprising:
- (a) a longitudinal axis;
(b) a distal edge substantially transverse to said longitudinal axis and configured for insertion into said measurement instrument; and
(c) an aligrunent notch formed in said distal edge for engagement with said alignment member and comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis.
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Accused Products
Abstract
Devices, systems, methods and kits are provided for use in determining the concentration of chemical and biochemical components in aqueous fluids. The subject devices include test strips which define a longitudinal axis and include a distal edge configured for insertion into a measurement instrument and having an alignment notch formed in the distal edge for engagement with an alignment member of the measurement instrument. The alignment notch has opposing edges wherein at least a portion of the opposing edges is in substantially parallel relation to the longitudinal axis. In using the subject devices, the devices are inserted into a measurement instrument having an alignment pin. When operatively engaged with the alignment pin, the notch serves to maintain the device in a substantially motionless position. The invention is useful in a variety of applications, particularly in the determination of blood glucose concentrations.
159 Citations
31 Claims
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1. A test device for insertion into a measurement instrument having an alignment member therein for engagement with said test device, said test device comprising:
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(a) a longitudinal axis;
(b) a distal edge substantially transverse to said longitudinal axis and configured for insertion into said measurement instrument; and
(c) an aligrunent notch formed in said distal edge for engagement with said alignment member and comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A test strip for use in conjunction with a measurement instrument having an alignment member therein and for measuring the concentration of at least one analyte within a sample of biological fluid, said test strip comprising:
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(a) a support member defining a longitudinal axis and comprising;
(i) a distal edge substantially transverse to said longitudinal axis and configured for insertion into said measurement instrument;
(ii) an alignment notch formed in said distal edge for engagement with said alignment member and comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis; and
(iii) an aperture therein for receiving said sample of biological fluid; and
(b) a reagent pad fixed to said support member and covering said aperture, said reagent pad containing at least one reagent material selected for reacting with said at least one analyte. - View Dependent Claims (14, 15, 16)
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17. A system for measuring the concentration of at least one target analyte in a sample of biological fluid, said system comprising:
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(a) at least one test strip having top and bottom surfaces, comprising;
(i) a substantially obround-shaped aperture for receiving a volume of from less than about 5 μ
l to about 10 μ
l of said sample of biological fluid;
(ii) a hydrophilic pad affixed to one of said top or bottom surfaces and covering said substantially obround-shaped aperture; and
(iii) an alignment notch comprising opposing parallel edges; and
(b) a measurement instrument comprising an alignment pin configured for engagement with said alignment notch wherein said test strip is maintained in a substantially motionless position with respect to said alignment pin when said test strip is operatively engaged within said test strip holder. - View Dependent Claims (18, 19)
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20. A method of measuring the concentration of at least one constituent in a fluid sample, the method comprising the steps of:
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(a) providing a test device defining a longitudinal axis and comprising;
(i) a distal edge substantially transverse to said longitudinal axis;
(ii) an alignment notch formed in said distal edge for engagement with an alignment pin of a measurement instrument adapted for measuring the concentration of said at least one constituent in said fluid sample, said alignment notch comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis; and
(iii) an aperture formed therein for receiving said fluid sample;
(b) inserting said test device into said measurement instrument; and
(c) operatively engaging said alignment notch with said alignment pin. - View Dependent Claims (21, 22, 23, 24)
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25. A kit for measuring the concentration of at least one constituent in a fluid sample, said kit comprising at least one test device defining a longitudinal axis and comprising:
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(a) a distal edge substantially transverse to said longitudinal axis;
(b) an alignment notch formed in said distal edge for engagement with said alignment member and comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis; and
(c) an aperture formed therein for receiving said fluid sample. - View Dependent Claims (26, 27, 28, 29, 30, 31)
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Specification