Patent Application
20080076169
The accompanying drawings, which are incorporated into and constitute a part of the specification, illustrate specific embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the specific embodiments, serve to explain the principles of the invention.
Referring to the drawings, to the following detailed description, and to incorporated materials, detailed information about the invention is provided including the description of specific-embodiments. The detailed description serves to explain the principles of the invention. The invention is susceptible to modifications and alternative forms. The invention is not limited to the particular forms disclosed. The invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the claims.
Referring now to the drawings, and in particular to
The system 10 is a lateral flow strip assay device. The device 10 is a simple-to-use sample collection and processing package for lateral flow strip assays. The device includes a lateral flow strip housing 11 with a lateral flow strip 12 in the housing 11. The lateral flow strip 12 has a receiving portion 13 that extends from the lateral flow strip housing 11. The system 10 includes a sample collection unit 14 and a reagent reservoir 15 containing a reagent 16.
The lateral flow strip 12 is a later flow strip such as that described in Published United States Patent Application No. 2005/0227371 by Cem Gokhan, assigned to Quidel Corporation, for a hybrid phase lateral flow assay, or later flow strips commercially available. The disclosure of Published United States Patent Application No. 2005/0227371 by Cem Gokhan, assigned to Quidel Corporation, for a hybrid phase lateral flow assay is incorporated herein by this reference.
The system 10 works by first collecting sample cells from an individual using the sample collection unit 14 then immersing the sample collection unit 14 into the reagent reservoir 15 then extracting the sample collection unit 14 from the reservoir 15 then immersing the receiving portion 13 of the lateral flow strip 12 into the reservoir 15. The reagent 16 and sample mixture wicks up the lateral flow strip 12 to perform the assay. The lateral flow strip 12 operates whereby the sample is applied at the end 13 and flows through the flow strip 12 matrix, binding with secondary and primary constituents that have been applied to the flow strip 12 during the manufacturing process.
The system 10 can be used to interrogate saliva for protein or RNA markers to determine the state of the person or animal being assayed. In particular, this device was developed for indications of radiological exposure by testing for the presence of certain proteins associated with exposure. The system 10 has use for markers for drug use or illness. Health officials can use the system 10 to detect illness in patients using appropriate markers in saliva, buccal, or other cells. Law enforcement personal can use the system 10 for drug use.
Referring now to
The system 20 is a lateral flow strip assay device. The device 20 is a simple-to-use sample collection and processing package for lateral flow strip assays. The system 20 has two parts, a rod-like platform 22 one end 21 of which is used to collect the sample and the other end of which houses the lateral flow strip 24, and a reagent container 30 which is used to remove sample from the collection tip 21 and introduce sample to the lateral flow strip 24 for analysis. The end 25 of the lateral flow strip 24 extends from the rod-like platform 22. The rod-like platform 22 includes a viewing window 23.
The system 20 can be used to interrogate saliva for protein or RNA markers to determine the state of the person or animal being assayed. In particular, the system 20 was developed for indications of radiological exposure by testing for the presence of certain proteins associated with exposure. The system 20 was developed as part of a project to develop suitable protein markers in saliva/buccal cell to indicate exposure to radiation and to then to develop a triage device for testing for the presence of these markers. Potential victims of a terrorist radiological event will express certain proteins indicative of radiation exposure. Saliva/buccal cells can be collected fairly readily by minimally trained personnel using the system 20 and analyzed for the expression of these proteins. This provides for quick, inexpensive testing of large numbers of affected individuals.
The lateral flow strip 24 is a lateral flow strip this currently available and is used for biological tests. The most common application is the home pregnancy test. Use of these strips for chemical tests in saliva is well known. The system 20 is a simple dual ended package, one end 21 for sample collection and the other end to house the lateral flow strip 24, and a separate reagent reservoir 30 to condition the sample. The end 25 of the lateral flow strip 24 extends from the end of the housing 22. The user simply sequentially places each end 21 and 25 into the reagent reservoir 30 after taking the sample.
The system 20 works by first collecting saliva and/or buccal cells from an individual using the sample collection component 21 then immersing the sample collection component 21 into the reagent reservoir 30, then extracting the sample collection component 21 from the reservoir 30, then turning the rod-platform 22 around (180 degrees) so that the tip 25 of the lateral flow strip 22 is then immersed into the reservoir 30 and the reagent/sample mixture wicks up into the strip 24 to perform the assay as shown in
The reservoir 30 contains a reagent mixture which is used to wash the material from the sample collection component 21. The reagent mixture can contain lysing solution to help extract proteins from the buccal cells. The solution can also be used to reduce the viscosity of the saliva sample to make the lateral flow assay proceed more rapidly. The entrance to the reagent reservoir 30 is tapered into an hour-glass shape such that a sponge collector can be squeezed while retracting the sponge from the reservoir to increase the volume of sample introduced into the reservoir. The sponge can be squeezed in the process of insertion into the reservoir to aid in mixing the sample. Sufficient height above the restriction prevents overflow of the sample. The reservoir can be sealed prior to use using a cap, a sealed lid or a septum.
The tip 25 of the lateral flow strip 24 which is housed in the rod-like structure 22 protrudes slightly from the housing 22. This tip 25 is immersed in the sample-regent reservoir 30 following introduction of the sample into the reservoir 30 as shown in
Referring now to
Referring now to
The system 60 is a lateral flow strip assay device. The device 60 is a simple-to-use sample collection and processing package for lateral flow strip assays. The system 60 includes a lateral flow strip housing 61 with a lateral flow strip in the housing 61.
The system 60 includes a rubber chew bar 62 that enhances sample collection. In the system 60 the sample collection unit consists of the rubberized chew bar 62 surrounding the sponge 63. A colorimetric humidity indicator 64 is incorporated into the unit. As the subject chews on the chew bar 62 and saliva is absorbed into the sponge 63 the indicator will change color as water is absorbed indicating sufficient sample collection.
The system 60 works by first collecting sample cells from an individual using the sample collection unit then immersing the sample collection unit into a reagent reservoir then extracting the sample collection unit from the reservoir then immersing the receiving portion of the lateral flow strip into the reservoir. The reagent and sample mixture wicks up the lateral flow strip to perform the assay.
The system 60 can be used to interrogate saliva for protein or RNA markers to determine the state of the person or animal being assayed. In particular, this device was developed for indications of radiological exposure by testing for the presence of certain proteins associated with exposure. The system 60 has use for markers for drug use or illness. Health officials can use the system 60 to detect illness in patients using appropriate markers in saliva, buccal, or other cells. Law enforcement personal can use the system 60 for drug use.
While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.
The United States Government has rights in this invention pursuant to Contract No. W-7405-ENG-48 between the United States Department of Energy and the University of California for the operation of Lawrence Livermore National Laboratory.
