Device for assaying analytes in bodily fluids

• US 10,076,314 B2
• Filed: 10/11/2016
• Issued: 09/18/2018
• Est. Priority Date: 02/16/2009
• Status: Expired due to Fees

• Current Assignee: Farmers & Merchants Savings Bank
• Original Assignee: Express Diagnostics Int'l, Inc.
• Inventors: Engel, Matthias W., Wilson, Leslie, Johnson, Paul
• Primary Examiner(s): Chin, Chris L
• Application Number:
  US15/290,503
• Publication Number:
  US 20180008240A1
• Time in Patent Office: 707 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: G01N 33/54388 based on lateral flow

Abstract

A device for determining the presence and/or quantity of one or more analytes in a sample of human body fluid has a container for receiving a sample of body fluid, with an interior that is delimited by a base and by a circumferential surface. It further comprises at least one test strip and a holding element for receiving and holding the one or more test strips. The holding element is designed such that it has a shape corresponding and adapted to the peripheral circumferential surface of the container. The device further comprises an elongate sampling element having an absorbent sampler that takes up the sample of body fluid and by means of which the sample of body fluid is transferred into the container. The sampling element can include an indicator strip for determining whether the amount of liquid sample sufficient for carrying out an assay.

Claims

1. A device for determining the presence and/or quantity of one or more analytes in a sample of human body fluid, comprising:

a container for receiving a sample of body fluid, with an interior that is delimited by a base and a wall,

at least one test strip with an absorbent section and with reagents for determining the presence and/or quantity of one or more analytes in the sample of body fluid, the test strip secured within the containers at the wall

an elongate sampling element with a first and a second end, has an absorbent sampler at one of the first and second ends that takes up the sample of body fluid, and wherein said absorbent sample is insertable into the container for transferring the sample of body fluid into the container,

wherein the container conveys the sample of body fluid from the sampler, by compression thereof in the container, to the at least one test strip,

wherein the elongate sampling element includes an indicator for indication of the presence of the liquid sample of sufficient quantity for the carrying out of the assay for determining the presence of the one or more analytes in the sample.

2. The device of claim 1, wherein the container has a hemispherical elevation arranged centrally on the base inside of the container.

3. The device of claim 2, wherein the elevation comprises ridge-shaped elements which extend centrally from the elevation towards the base for conveying the sample of body fluid to a peripheral edge of the base of the container.

4. The device of claim 1, wherein the base of the container has a depression at the wall, for receiving the sample of body fluid from the sampling element.

5. The device of claim 4, wherein the at least one test strip, with its absorbent section taking up the sample of body fluid, extends into the depression.

6. The device of claim 1, wherein the sampling element, at its end remote from the end with the sampler has a closure means for closing the container after the sampling element has been introduced into the container.

7. The device of claim 6, wherein the closure means is provided with blocking means for blocking the removal of the sampling element from the container after the sampling element has been introduced into the container.

8. The device of claim 6, wherein the container has a pierceable self-sealing sampling element for permitting, after it has been pierced, access to the interior of the container even after the closure means has been fitted onto the container.

9. The device of claim 1, wherein means for indicating the presence of an amount of the liquid sample that is sufficient for determining the presence and/or the amount of one or more analytes in the sample is in a hollow rod.

10. The device of claim 9, wherein the means are an indicator strip of an absorbent material present in the sampling element.

11. The device of claim 10, wherein the indicator strip has a zone for indicating the amount of the liquid sample that is sufficient for determining the presence and/or the amount of one or more analytes in the sample.

12. The device according to claim 10, wherein the sampling element has a marking for indicating the minimum travelling distance of the sample of body fluid through the indicator strip for indicating that the amount of the liquid sample is sufficient for determining the presence and/or the amount of one or more analytes in the sample.

13. The device of claim 1, wherein the container is a cylindrical container with a circular base and wherein a holding element has a shape adapted to the circular cross section of circumferential surface, such that the holding element is formed peripherally over an inner circumference of the circumferential surface.

14. The device of claim 1, wherein the container is a cuboid container with an essentially rectangular base, having two short and two long edges forming the essentially rectangular base, and wherein a holding element has a shape adapted to a cross section of a circumferential surface such that that the holding element is formed peripherally over an inner circumference of the wall.

15. The device of claim 3, wherein the base of the container has means by which the sample of body fluid can be conveyed to the depression of the base.

16. The device of claim 1, wherein a holding element is shaped with pretensioning and is clamped into the container.

17. The device of claim 1, wherein a holding element is at least partially bonded to a circumferential surface on the inside of the container and/or of the base.

18. The device of claim 1, wherein a holding element has recesses in which the test strips are respectively arranged.

19. The device of claim 1, wherein test strips are provided for the detection of at least one drug and/or medicament selected from the group consisting of amphetamines, barbiturates, benzodiazepines, cocaine, marihuana, methadone, methamphetamine, methylenedioxy-meth-amphetamine, morphine, opiates, oxycodone, phencyclidine, propoxyphene, tricyclic antidepressants, buprenorphine, cotinine, EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine), fentanyl, and alcohol.

20. The device of claim 1, wherein the sampling element is a hollow, rod-shaped element, with a sampler arranged on one of its end to be inserted into the container and with an insertion element, which is arranged in the rod-shaped element and has a recess for an indicator.