Sample collector and test device

• US 7,879,293 B2
• Filed: 11/30/2001
• Issued: 02/01/2011
• Est. Priority Date: 09/28/2001
• Status: Expired due to Fees

• Current Assignee: Orasure Technologies Incorporated
• Original Assignee: Orasure Technologies Incorporated
• Inventors: Feindt, Hans H., Niedbala, R. Sam, Bourdelle, Peter A., Scott, John W.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/997,023
• Publication Number:
  US 20030064526A1
• Time in Patent Office: 3,350 Days
• Field of Search: 422/58, 422/61, 422/99, 422/100, 422102-104, 422/101, 436/164, 436/165
• US Class Current: 422/501
• 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: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0835 Ampoules
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A sample collector and test device is disclosed. The sample collector and test device may be used together as a diagnostic tool for collecting and assay of analytes contained in a sample. A sample collector is also disclosed which may be used with existing sample containers and or test devices. The sample collector may indicate sample adequacy when a sufficient volume of sample has been collected for assay and may also include a sample retaining feature which retains a portion of expressed sample for confirmatory testing, if desirable. The sample collector may also include a mechanism for expressing sample in a sample collector and/or test device. A test device is also disclosed for retaining and assay of an expressed sample. The disclosed test device may be used with existing sample collectors. In a preferred embodiment, test device is used with a preferred sample collector. Test device may include a locking feature for locking a sample retained on a sample collector or test device may be used to receive expressed sample collected from a syringe or another suitable sample delivery device.

Claims

1. A sample collection device for assay comprising:

a handle portion having a first end and a second end;

a collector portion having a first end and a second end,

the collector portion first end detachably coupled to the handle portion second end and

the collector portion second end having

a base being movable relative to the handle portion second end when the collector portion first end is coupled to the handle portion second end;

a plunger arm coupled to the base and including a first diameter portion and a second diameter portion, the first diameter portion being smaller than the second diameter portion; and

an expandable sponge coaxially disposed on the first diameter portion and on the second diameter portion of the plunger arm between an end wall of the collector portion and the base resulting in an extended collection size of the sponge; and

wherein the plunger arm is moved relative to the handle portion second end such that the second diameter portion of the plunger arm engages a flange reconfiguring the sponge to a smaller sample retaining size and discharging a first portion of the sample for assay and retaining a second portion of the sample in the sponge for subsequent assay.

2. The sample collection device for assay of claim 1, wherein the sponge is made from a fluid absorbing material and the sample is discharged from the sponge by compressing the sponge between the base and the handle portion second end.

3. The sample collection device for assay of claim 1, wherein the collector portion includes an elongate member and a locking portion that includes a raised portion formed on the elongate member, and the handle portion second end includes a wall sized to engage with the raised portion of the elongate member when the collector portion is moved from one of the extended size to the sample retaining size.

4. The sample collection device for assay of claim 1, wherein the handle portion includes a housing defining an opening for slidably receiving the collector portion so as to permit the collector portion to be selectively configurable between the extended size and the sample retaining size.

5. The sample collector device for assay of claim 1, wherein the sponge has a first length when the sponge has the sample retaining size, the sponge has a second length when the sponge has the extended collection size, and the collector portion has an extended length when the sponge is disposed on the plunger arm between the end wall of the collector portion and the base;

and

wherein a sufficient sample is collected for assay when the sponge extended collection size is substantially equal to the collector portion extended length.

6. The sample collector device for assay of claim 1, wherein the sponge size is reduced from the extended collection size to the sample retaining size when the collector portion is configured from an extended size to a sample retaining size.

7. A test device in combination with the sample collection device for assay of claim 1, the test device being adapted to connect with the sample collection device and including a tester to assay for analytes in the sample, the test device including:

an opening sized to receive the handle portion; and

a discharge surface adapted to engage with the collector portion, wherein the sponge extended collection size is substantially equal to the collector portion extended collection size before engaging the collector portion with the discharge surface, and the sample collection device is in fluid communication with the tester and the collector portion is configured in the sample retaining size when the collector portion is engaged with the discharge surface.

8. The test device in combination with the sample collection device for assay of claim 7, wherein the handle portion second end includes an engagement surface and the test device includes a mating surface adapted to engage with the engagement surface, wherein the handle portion is fixed to the test device when the engagement surface engages with the mating surface.

9. The test device in combination with the sample collection device for assay of claim 8, wherein the mating surface engages with the engagement surface by elastic deformation of at least one of the mating surface and the engagement surface.

10. The test device in combination with the sample collection device for assay of claim 8, wherein the handle portion is fixed to the test device by a friction fit between the engagement and mating surfaces.

11. The test device in combination with the sample collection device for assay of claim 8, wherein the sponge extended collection size is substantially equal to the collector portion extended collection size when the mating surface engages with the engagement surface.

12. The test device in combination with the sample collection device for assay of claim 8, wherein the handle portion includes a second engagement surface and the test device includes a second mating surface adapted to engage with the second engagement surface, wherein when the second engagement surface is in contact with the second mating surface, the discharge surface engages with the collector portion.

13. The test device in combination with the sample collection device for assay of claim 7, wherein the tester is a lateral flowstrip in fluid communication with the sponge when the handle portion is fixed to the test device and the collector portion is in the sample retaining size.

14. The test device in combination with the sample collection device for assay of claim 7, wherein the test device further includes an ampoule containing fluid and the ampoule is violated when the collector portion is configured to the sample retaining size.

15. The test device in combination with the sample collection device for assay of claim 7, wherein the handle portion first end comprises a grip and the first end is removable from the second end.

16. The sample collection device for assay of claim 1, wherein the second portion of sample corresponds to an assay sample that is substantially contained in the sponge, the assay sample being transferable from the sponge to a test device for assay of the assay sample.

17. The test device in combination with the sample collection device for assay of claim 7, wherein the sponge has the sample retaining size when the sample collector is in fluid communication with the tester.

18. A sample collection device for assay comprising:

a handle portion having a first end and a second end;

a collector portion having a first end and a second end,

the collector portion first end being coupled to the handle portion second end and

the collector portion second end being movable relative to the handle portion second end when the collector portion first end is coupled to the handle portion second end, the collector portion having at least an extended size and a sample retaining size, the sample retaining size being smaller than the extended size, the sizes being defined by a configurable distance between the collector portion second end and the handle portion second end;

the collector portion second end also including a plunger arm coupled to the collector portion and including a first diameter portion and a second diameter portion, the first diameter portion being smaller than the second diameter portion; and

a locking portion disposed on the collector portion, the locking portion being spaced from the handle portion second end when the collector portion is configured in the extended size and the locking portion being engaged with the handle portion second end when the collector portion is configured in the sample retaining size, and

a sponge coaxially disposed on the first diameter portion and the second diameter portion of the plunger arm between the locking portion and the collector portion second end resulting in an extended collection size of the sponge when the sponge holds a first amount of sample;

wherein the plunger arm is moved relative to the handle portion second end such that the second diameter portion of the plunger arm engages the locking portion reconfiguring the sponge to a smaller sample retaining size and discharging a first portion of the sample for assay and retaining a second portion of sample in the sponge for subsequent assay.

19. The sample collection device for assay of claim 18, wherein the locking portion is formed on the collector portion.

20. The sample collection device for assay of claim 19, wherein the locking portion is received within the handle portion when the collector portion is configured from the extended size to the sample retaining size.

21. The sample collection device for assay of claim 18, wherein the collector portion further includes:

a first diameter portion having a first length and a first width dimension wherein the first length substantially corresponds to the sample retaining size of the sponge, and

a second diameter portion having a second length and a second width dimension, wherein the total length of the first length and the second length substantially corresponds to the extended collection size of the sponge.

22. The sample collection device for assay of claim 18, wherein when the collection portion has the extended size and is configured from the extended size to the sample retaining size, the sponge is configured from the extended collection size to the sample retaining size and a sample sufficient for a first assay is expressed from the sponge.

23. The sample collection device for assay of claim 18, wherein the sponge is made from a fluid absorbing material and the collector portion expresses fluid sufficient for assay of sample from the sponge when the collector portion is configured from the extended size to the sample retaining size.

24. A sample collection device for assay comprising:

a handle portion having a first end and a second end;

a collector portion having a first end operably connected to a second end,

the collector portion first end being coupled to the handle portion second end and

the collector portion second end having

a base being movable relative to the handle portion second end when the collector portion first end is coupled to the handle portion second end;

the collector portion second end also including a plunger arm coupled to the collector portion and including a first diameter portion and a second diameter portion; and

a sponge coaxially disposed on the first diameter portion and on the second diameter portion of the plunger arm between the handle portion second end and the base resulting in an extended collection size of the sponge; and

;

wherein the base is moved relative to the handle portion second end such that the second diameter portion of the plunger arm engages a flange reconfiguring the sponge to a smaller sample retaining size and discharging a first portion of the sample for assay and retaining a second portion of the sample in the sponge for subsequent assay.

25. The sample collection device for assay of claim 24, wherein the second portion of sample includes at least a first assay sample and a second assay sample.

26. The sample collection device for assay of claim 24, wherein the sponge is made from a fluid absorbing material and the sample is discharged from the sponge by compressing the sponge between the base and the handle portion second end.

27. A sample collection device for assay comprising:

a handle portion having a first end and a second end;

a collector portion coupled to the handle portion second end and selectively configurable between at least an extended size and a sample retaining size;

the collector portion also including a movable base positioned at a first length from the handle portion second end when the collector portion is in the extended size and positioned at a second length from the handle portion second end when the collector portion is in the sample retaining size,

the collector portion also including a plunger arm coupled to the base and including a first diameter portion and a second diameter portion; and

an expandable sponge coaxially disposed on the first diameter portion and on the second diameter portion of the plunger arm between the collector portion and the handle portion second end and having a dry size, a sample retaining size when the sponge holds a first amount of the sample and a extended size when the sponge holds

a second amount of the sample, the sample retaining size being smaller than the extended size and the first amount of sample being sufficient for assay;

wherein a sufficient sample is collected for assay when the sponge extended size is substantially equal to the collector portion extended size,

wherein the plunger arm is an elongate member having a proximal end adjacent the handle portion second end and the base formed at a distal end, wherein the base is a perforated disc,

wherein the sponge is made from a fluid absorbing material that is movable along the elongate member to place the sponge in the extended collection size and

wherein the plunger arm has a first diameter portion having a first length and a first width dimension wherein the first length substantially corresponds to the sample retaining size of the sponge, a second diameter portion proximal from the handle portion second end relative to the first diameter portion and having a second length and a second width dimension that is smaller than the first width dimension, wherein the total length of the first length and the second length substantially corresponds to the extended collection size of the sponge, and wherein the handle portion second end defines an opening sized for slidably receiving the plunger arm, such that as the plunger arm slides within the opening, the opening impedes the movement of the first length of the plunger arm, thus defining the sample retaining size.