MULTI-STAGE ORAL-FLUID TESTING DEVICE
First Claim
1. A multi-stage, oral-fluid collection and testing device for collecting and testing an oral-fluid for substances, the testing device comprising:
- a body assembly, including;
a collection sponge for absorbing an oral fluid received from a donor,a test strip for receiving the oral fluid and presenting a visual indicator indicating presence of a predetermined substance,a body portion securing the collection sponge and the test strip and defining a fluid reservoir and a test strip channel, the test strip located in the test strip channel; and
a cap assembly, including;
a cap having a first closed end and a second open end, and configured to receive a portion of the body assembly, the cap defining a cap cavity;
a fluid container having a sealing membrane and containing a fluid for mixing with the oral fluid, the fluid container housed within the cap cavity, anda plunger defining a fluid channel;
wherein the cap assembly is configured to release the fluid for mixing onto the collection sponge upon receiving a cap-engagement portion of the body portion in a first engagement position, thereby causing a first-stage fluid flow.
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Accused Products
Abstract
In an embodiment, the claimed invention includes an oral-fluid collection and testing device that. is simple to operate. The device includes a body assembly and a cap assembly that are easy to handle by a user. A collection sponge projects from an end of the body assembly for absorbing the oral fluid of a donor, A cap assembly is easily aligned with the body assembly by way of visual alignment indicators on both the body and the cap. Once the cap is aligned with the body, a user simply pushes the cap onto the '"'"'body, which causes a first stage fluid, flow. More specifically, a buffer fluid is released from the cap and mixes with the oral fluid collected on the sponge—After waiting a short time* the cap is rotated, then pushed again, causing a second-stage fluid flow in which the sponge is compressed such that the buffer fluid/oral fluid exits the sponge and flows toward a. pair of test strips. A user can then easily view the test results by observing a visual indication, such as a color change of the test strips through a viewing window.
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Citations
25 Claims
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1. A multi-stage, oral-fluid collection and testing device for collecting and testing an oral-fluid for substances, the testing device comprising:
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a body assembly, including; a collection sponge for absorbing an oral fluid received from a donor, a test strip for receiving the oral fluid and presenting a visual indicator indicating presence of a predetermined substance, a body portion securing the collection sponge and the test strip and defining a fluid reservoir and a test strip channel, the test strip located in the test strip channel; and a cap assembly, including; a cap having a first closed end and a second open end, and configured to receive a portion of the body assembly, the cap defining a cap cavity; a fluid container having a sealing membrane and containing a fluid for mixing with the oral fluid, the fluid container housed within the cap cavity, and a plunger defining a fluid channel; wherein the cap assembly is configured to release the fluid for mixing onto the collection sponge upon receiving a cap-engagement portion of the body portion in a first engagement position, thereby causing a first-stage fluid flow. - View Dependent Claims (2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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4. The testing device of claim 4, wherein the second stage fluid flow further comprises the oral-fluid mixture contacting the test strip and flowing through the test channel toward a distal end of the body portion and away from the cap assembly.
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15. A method of testing an oral fluid for a substance, the method comprising:
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receiving an oral fluid at a collection sponge of a testing device, the testing device including a cap assembly and a body assembly; rotationally aligning the cap assembly with the body assembly, the cap assembly including a fluid container having fluid and a plunger; moving the cap assembly to a first engagement position to receive a cap-engagement portion of the body assembly, thereby causing the plunger to pierce a membrane of the fluid container and causing fluid to flow from the fluid container through the plunger and to the collection sponge; rotating the cap assembly relative to the body assembly; and moving the cap assembly to a second engagement position, thereby causing the collection sponge to be compressed and causing a mixture of the fluid and the oral fluid to flow into a fluid reservoir of the body assembly. - View Dependent Claims (16, 17, 18, 19, 20)
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21. A method of testing an oral fluid for a substance, the method comprising:
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receiving an oral fluid at a collection sponge of a testing device, the testing device including a cap assembly and a body assembly, the sponge attached to the body assembly; engaging the cap assembly with the body portion with the sponge therebetween; moving axially the cap to release a buffer solution that travels to the sponge; compressing the sponge with the buffer solution and saliva into a restricted region with a saliva pathway outlet that leads to a test strip. - View Dependent Claims (22, 23, 24, 25)
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Specification