Rapid sample collection and analysis device and methods of use

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.

Description

[0001] This application claims priority to U.S. provisional patent application Ser. No. 60 / 520,437, filed Nov. 14, 2003, which is incorporated by reference herein, including all Tables, Figures and claims.FIELD OF THE INVENTION [0002] The present invention is directed to devices for the rapid analysis of fluids for analytes of interest and the storage of those fluids. BACKGROUND OF THE INVENTION [0003] The following Background of the Invention is intended to aid the reader in understanding the invention and is not admitted to be prior art. [0004] Illicit drug use is an established and growing problem in our society. In 2003, the US Department of Health and Human Services found that an estimated 19.5 million Americans or 8.2 percent of the population aged 12 or older, were current illicit drug users. Current illicit drug use means use of an illicit drug during the month prior to the US Department of Health and Human Services survey interview. Marijuana was found to be the most common...

AI Technical Summary

Benefits of technology

[0013] In one embodiment the sample collection well also has a lower chamber present when the plunger is in the raised position, and an upper chamber where the confirmation sample is stored. In one embodiment the sample collection well contains the plunger, upper and lower chambers, the expression plate, and the sample outlet, however, in other embodiments these components can be located outside the sample collection well. In one embodiment, expression plate divides the upper chamber from the lower chamber, and has an aperture for flow of liquid sample from the upper chamber to the lower chamber. The lance can be carried on the plunger (e.g., on the bottom surface of the plunger), and can be downwardly-projecting and perpendicularly aligned with the sample outlet for breaking the frangible material. The sample collection well and cap can have complementary engaging screw threads. In one embodiment the cap carries a downward projection that interacts with the plunger when the cap is applied to the sample collection well. The expression plate can have an opening through which the projection passes to interact with (and push) the plunger. By “complementary engaging screw threads” is meant that the cap and sample collection well each have screw threads which are complementary and the cap can be screwed onto the sample collection well to obtain a fit by rotation of the cap on the sample collection well and engagement of the screw threads, and where liquid sample does not leak from around the cap.

Problems solved by technology

Illicit drug use is an established and growing problem in our society.

These devices can be complicated and difficult or messy to use, or they may pose special problems of sample adulteration by the subject trying to hide their recent drug abuse.

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