Screening device for analysis of bodily fluids

Abstract

A screening device for testing bodily fluids for the presence of certain constituents. The device can include a planar front face through which all of the test strips are viewed. The device also includes an inclined surface that directs the fluid under test to test strips with more efficiency, and partitions the fluid that is directed to a given test strip to better assure that the test strip receives an adequate amount of bodily fluid for a valid analysis. In one embodiment, the device includes a three-dimensional gasket that creates a pressurized environment upon insertion of the sampling stem for improved diffusion of the bodily fluid into the test strips.

Description

RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Patent Application No. 61 / 725,898, filed Nov. 13, 2012, the disclosure of which is incorporated by reference herein in its entirety.FIELD OF THE INVENTION[0002]This application is directed generally to devices and methods for analysis of the presence of constituents in fluids, and more specifically to devices and methods for analysis of the presence of constituents in bodily fluids for drug test screening.BACKGROUND OF THE INVENTION[0003]Various drug screening devices are known for testing a sample of bodily fluids for the presence of certain constituents. These devices typically include a container for receiving a bodily fluid from a delivery device, and a plurality of reagent test strips arranged to contact the bodily fluid, with each test strip being sensitive to a particular constituent of interest. The targeted constituents for screening can range from controlled substances such as alcohol and mar...

AI Technical Summary

Benefits of technology

[0008]Structurally, various embodiments of the invention include a container or cup having a first or “viewing” side through which all of the test strips can be viewed. The bottom of the cup is inclined and intersects the viewing side along a junction line that constitutes the lowest portion of the cavity within the cup where the bodily fluid collects. The test strips are oriented so that the detection end proximate the junction line for in contact with the bodily fluid that collects at the low portion of the cavity. By this arrangement, all of the test strips can be inspected by viewing a single surface of the cup, and the inclined surface of the bottom of the cup directs all of the bodily fluid into contact with the detection end of the test strips. Furthermore, the angle of the intersection between the bottom and the viewing side can be steep enough to counter a substantial holding angle induced by the operator.

[0009]In certain embodiments, a three-dimensional gasket is implemented to provide certain sealing and pressurization advantages. The three-dimensional gasket can be made of a soft, pliable material to provide a sealing surface between the gasket and the cup and to provide a seal between a sampling stem that is inserted through the gasket. The pliable material can also cause the three-dimensional gasket to act as a diaphragm; when the sampling stem is inserted into the three-dimensional gasket, the displaced air causes the three-dimensional gasket to expand (as would a diaphragm), thereby causing the air contained by the three-dimensional gasket to become slightly pressurized. The pressurization can assist in the diffusion of the bodily fluid into the test strips, thus augmenting the capillary action between the bodily fluid and the test strip.

[0010]The device can also provide barriers between the detection ends of adjacent test strips to prevent more absorbent or faster absorbing test strips from drawing test fluid away from less absorbent or slower absorbing test strips.

[0011]A feature and advantage of embodiments of the invention is a specimen sampling device for saliva where the saliva is absorbed in a sponge, is squeezed into a saliva pathway of a specimen container, the saliva pathway is pressurized urging the saliva into engagement with a plurality of sample test strips. In embodiments a vent may be provided downstream of where the saliva engages the test strips. In embodiments, the plurality of test strips are each positioned in a plurality of recesses in a row, the recesses having an overfill level whereby fluid that overflows one recess flows into an adjacent recess. In embodiments, the pressurization may be provided by a stem attached to the sponge, the stem having a sliding plunger member. In embodiments the pressurization may be provided by a separate manual squeeze or push pump as part of the specimen sampling device.

[0012]Another feature and advantage of embodiments of the invention is a specimen sampling device for saliva where the saliva is absorbed in a sponge, is squeezed into a saliva pathway of a specimen container, the saliva pathway leading to a plurality of sample test strips aligned in a linear row of at least 8 strips positioned on a substantially planar wall and exposed to be readable through one or more transparent regions, the strips having a sample receiving end that is placed at the bottom of an inclined plate in the saliva pathway. In some such embodiments, embodiments may have a gasket sealingly enclosing a specimen chamber including the inclined plate and a row of recesses into which the at least 8 strips extend. In some such embodiments, a curved, wall is positioned opposite the planar wall.

[0013]An additional feature and advantage of embodiments of the invention is a specimen sampling device for saliva where the saliva is absorbed in a sponge, is squeezed into a saliva pathway of a specimen container, the saliva pathway leading to a plurality of sample test reservoirs, each with test strip extending therein, a gasket with a separate aperture for each respective test strip, the gasket providing sealing between the saliva pathway including and the reservoirs and regions of the container above the saliva pathway thereby preventing unintended migration of the saliva upward.

Problems solved by technology

One problem with the prior art arrangement of having a plurality of test strips arrayed on several sides of a test container is that the arrangement is prone to operator error.

While holding the device, there is a tendency to tilt the proximal face of the device backward for easier reading.

Unfortunately, this can cause the bodily fluid under test to pool at the bottom of the distal face of the testing device, thus starving the test strips that are disposed on the proximal face.

The result is an invalid test for the constituents represented by the test strips on the proximal face.

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