Rapid sample collection and analysis device and methods of use
First Claim
1. A test device for detecting an analyte suspected of being present in a fluid sample, comprising:
- a casing, comprising a port for a sample collection well;
a sample collection well, situated in the port and comprising an expression plate, and a plunger having a raised position and a lower position;
a chamber for storage of a confirmation sample;
a test compartment containing at least one test element;
a sample outlet sealed by a frangible material and providing liquid communication between the sample collection well and the test compartment when the sample outlet is open;
a lance for piercing the frangible material; and
a cap for the sample collection well, wherein a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well.
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Accused Products
Abstract
The present invention is directed to devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more. The invention also provides methods of using the devices, and kits containing the devices.
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Citations
33 Claims
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1. A test device for detecting an analyte suspected of being present in a fluid sample, comprising:
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a casing, comprising a port for a sample collection well; a sample collection well, situated in the port and comprising an expression plate, and a plunger having a raised position and a lower position; a chamber for storage of a confirmation sample; a test compartment containing at least one test element; a sample outlet sealed by a frangible material and providing liquid communication between the sample collection well and the test compartment when the sample outlet is open; a lance for piercing the frangible material; and a cap for the sample collection well, wherein a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well. - View Dependent Claims (3, 4, 5, 6, 7, 9, 10, 12, 15, 16)
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2. The device of claim I wherein the plunger and expression plate are comprised within the sample collection well, and the sample collection well further comprises a lower chamber when the plunger is in the raised position, and an upper chamber where the confirmation sample is stored;
- and wherein the lance is carried on the plunger.
- View Dependent Claims (8, 17)
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11. The device of claim I wherein the test strip comprises specific binding molecules immobilized on the test strip.
- 13. The device of claim I wherein the fluid sample is selected from the group consisting of oral fluid, blood, serum, plasma, urine, feces, spinal fluid, vaginal swabs, mucus, and tissue.
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18. A kit comprising:
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a device comprising a casing, comprising a port for a sample collection well; a sample collection well, situated in the port and comprising an expression plalte, and a plunger having a raised position and a lower position; a chamber for storage of a confirmation sample; a test compartment containing at least one test element; a sample outlet sealed by a frangible material and providing liquid communication between the sample collection well and the test compartment when the sample outlet is open; a lance for piercing the frangible material; a cap for the sample collection well, wherein a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well; and a sample applicator. - View Dependent Claims (19, 20, 21, 22, 23)
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24. A method of detecting the presence of an analyte in a fluid sample comprising,
applying the fluid sample to a device comprising, a casing comprising a port for a sample collection well; -
a sample collection well, situated in the port and comprising an expression plate, and a plunger having a raised position and a lower position; a chamber for storage of a confirmation sample; an expression plate; a test compartment containing at least one test element; a sample outlet sealed by a frangible material and providing liquid communication between the sample collection well and the test compartment when the sample outlet is open; and a lance for piercing the frangible material; and a cap for the sample collection well, wherein a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well; applying the cap to the sample collection well and engaging the plunger; lowering the plunger so that the lance punctures the frangible material and releases the fluid sample into the test compartment; and determining the presence of the analyte in the fluid sample. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33)
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Specification