Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Reexamination Certificate
2001-04-13
2004-12-21
Alexander, Lyle A. (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
C422S067000, C436S164000, C436S169000, C436S808000, C600S584000
Reexamination Certificate
active
06833111
ABSTRACT:
The present invention generally relates to an assaying device and more specifically relates to an analyte assaying device with a multiple sample introduction system.
Devices for testing for the presence of single or multiple substances, (i.e. “analytes”) in a single fluid sample, for example a urine or blood specimen, are well known. The demand for inexpensive, accurate and simple to use devices for testing, or assaying, biological specimens has increased in recent years. Various commercial assaying devices are available for use in hospitals, clinics, research laboratories, at home and in the workplace. Following now are some specific, common examples illustrating the use of assaying devices. For example, in a hospital setting, patients are often subjected to massive dosages of antibiotics to defeat an infection, and thereafter a small amount of blood may be withdrawn from the patient and the serum assayed for determining if an appropriate amount of antibiotic is present in the blood. As another specific example, in a hospital emergency room where an overdose patient has impaired cognitive function, or is a small child unable to communicate, the type of drug overdosed may be quickly determined using an available assaying device in order to ensure correct administration of treatment. Assaying devices are commonly used in other settings as well. For example, many employers now routinely administer so called “drug tests” to prospective and current employees in order to maintain a safe work environment. In addition, pregnancy and fertility test kits adapted for “in home” use, are now widely available to consumers. Such test kits include assaying devices which are, for the most part, accurate, and very easy to use.
A common form of assaying device is a lateral flow test device which generally includes a porous element of nitrocellulose or paper, typically in strip form, having chemical reagents striped or incorporated onto specific regions, or “zones” thereof. One zone may include a specific binding reagent for the analyte, bearing a visible label such as a colored latex particle. The labeled reagent is incorporated onto the porous element in a manner that allows it to freely migrate through the porous material, in the presence of a liquid specimen sample. Another zone, spatially distinct from the first zone, may include an unlabeled specific binding reagent having specificity for same analyte as the first zone, and which is capable of participating with the labeled reagent in either a “sandwich” or “competition” reaction. The unlabeled specific binding reagent may be firmly immobilized on the porous element such that it is not free to migrate through the porous material, even in the moist state. In a “sandwich” type assay, any analyte present in the specimen sample will become labeled as it is carried through the porous element and bound, where its presence is manifested by a detectable color change.
Many such test devices for detecting body fluid components are capable of making not only qualitative, but also quantitative or semi-quantitative measurements. Thus, by observing a color change response after a certain period of time, an analyst can obtain not only a positive indication of the presence of a specific component, but also an estimate of how much of the component is present in the sample.
Assaying devices may take the form of a dip-and-read type device, in which one portion of the porous element is immersed in a specimen sample, such as in a collection cup, or a urine stream. May et al. U.S. Pat. No. 5,602,040 issued on Feb. 11, 1997, discloses such a dip-and-read type device which includes an elongated case having a porous test strip disposed within, and a protective, removable cap or shroud. The cap is used to cover a sample receiving member protruding from the casing, after the sample receiving member has been contacted with a urine specimen. Other assaying devices are designed to be placed horizontally on a table top and include a case enclosing a porous test element, the casing typically including a receptacle in which a measured amount of specimen sample is deposited using a syringe, for example.
Conventional assaying devices have also been developed which include multiple lateral flow test elements which allow for detection of more than one type of analyte in a single fluid specimen. For example, U.S. Pat. No. 5,976,895 issued to Cipkowski on Nov. 2, 1999 discloses such a device. The Cipkowski device includes a transparent container having a lid with a slit for receiving a single test card having multiple test strips. Procedure of use requires a test subject to fill the container with a urine specimen, and place the lid on the container. The test card with multiple strips is then manually inserted through the slit in the lid such that a portion of each strip is immersed in the specimen. Each strip absorbs some of the specimen. The card is left in the container for a period of time and test results are read on the test card by observation through the transparent container walls.
Although these and other assaying devices are generally easy to use in both a clinical and home setting, the procedures of their use are less than desirable in a situation where many different tests must be conducted on a regular, frequent basis, for example at a drug testing laboratory.
It would be highly desirable to be able to test a single fluid specimen for a number of different substances using a compact, unitary device which requires no measuring or timing. Moreover, it would be advantageous if such a device was designed to require minimal handling, was sanitary to use and did not require separate caps or coverings to prevent contamination of the laboratory work table.
The present invention provides a sample fluid test card device containing single or multiple test strips for assaying a fluid specimen. The present device promotes hygienic laboratory conditions, is easy to use, and facilitates the assaying process in comparison to currently available assaying devices.
SUMMARY OF THE INVENTION
Accordingly, an analyte assaying device with a unique sample introduction system is provided. The device enables automatic specimen volume measurement, automatic controlled specimen metering, no wet contact of the device with the laboratory counter top, controlled flow venting for preventing test strip flooding and other advantages features which facilitate assaying of a fluid specimen.
Generally, the device comprises a casing and means, disposed in the casing, for assaying a fluid specimen, for example, but not limited to a biological fluid specimen, for example urine. The assaying means preferably comprises a testing assembly including at least one test strip element, disposed within the casing. In one embodiment of the invention, the test assembly comprises multiple lateral flow test strips for enabling several different assays to be performed on a single fluid specimen. Each test element includes a sample introduction region and a detection region where chemical interactions take place to reveal a presence or absence of an analyte of interest depending upon the assaying test being performed. The test assembly preferably further comprises a sample pad for receiving the fluid sample, and an absorbent end pad. The sample pad may overlap the sample introduction region of each of the test elements. The fluid specimen absorbed by the sample pad then permeates and is absorbed by the sample introduction region of the test element and migrates into the detection region by capillary action. The absorbent end pad, provides means for absorbing any excess fluid or moisture in the casing before, during and/or after the assaying procedure.
The casing preferably comprises a cover, a base, a pocket portion and an observation portion. The cover and base form a substantially hollow cavity within the casing in which the testing assembly is disposed. Multiple frets are defined by interior surfaces of the cover and/or base in order to secure alignment of the test elements.
The observation portion of the casing def
Bachand Steven S.
Blevins Dennis D.
Grenz Robert L.
McPhee Lawrence C.
Robertson John L.
Alexander Lyle A.
Hackler Walter A.
Varian Inc.
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