Lateral flow test strip
The present invention provides a test strip having a first layer comprising a wicking member and a second layer comprising a capillary transfer plane member. The capillary transfer plane has a plurality of capillary transfer passages. The capillary transfer passages can comprise various shapes to control sample flow rate. Located above the capillary transfer passages are a plurality of testing members. The test strip can include a third layer next to the wicking member, the third layer comprising a backing member for providing support to the wicking member. Another aspect of the present invention provides a sample testing device, which includes a housing having a plurality of openings, and a test strip as described above, wherein a sample application area of the test strip is accessible through one of the openings in the housing, and each of the testing members is viewable through one of the openings of the housing.
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This application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application Ser. No. 60/115,984 filed Jan. 15, 1999.
FIELD OF THE INVENTIONThis invention relates to the field of sample testing systems, and specifically to a lateral flow test strip and apparatus.
BACKGROUNDTesting of bodily fluids for drugs is an increasingly important field because of increased recognition of the need for safety. For example, employers have the need to test employees in dangerous jobs such as construction, truck driving or piloting. Also, testing bodily fluid samples for other purposes, such as disease detection and other diagnostic purposes, is also important.
In the past, assorted systems for collecting and testing samples have been used. For example in one method, when a test is needed, a sample, usually urine, blood, or another bodily fluid, is deposited into a cup. Currently, the user places a dipstick into the collection cup, assuring that all test sites on the dipstick are submerged within the fluid. The dipstick remains in the sample fluid for approximately one second. The dipstick is then removed by dragging it along the edges of the specimen cup to remove excess urine or other fluid. Some type of absorbent paper must be placed on a flat surface, upon which the dipstick will be placed, with test sites up, to absorb all excess fluid. The dipstick must not be left in the collection cup any longer than one second because the chemicals used in the test area will begin to dissolve into the sample, coming off the test area, thereby providing inaccurate test results because of cross-contamination.
Overall, this is an unsanitary process that can result in urine getting onto counter-tops, clothes, instruments, etc. Also, if multiple samples are being tested, as is the case in a laboratory environment, it is difficult to efficiently identify multiple samples once they are removed from the collection cup.
For the reasons stated above and for other reasons stated below which will become apparent to those skilled in the art upon reading and understanding the present specification, there is a need in the art for a better method and apparatus for performing testing of samples.
SUMMARY OF THE INVENTIONIn one embodiment, the present invention provides an a test strip having a first layer comprising a wicking member and a second layer comprising a capillary transfer plane member. The capillary transfer plane member has a plurality of capillary transfer passages. Located above one or more of the capillary transfer passages are a plurality of testing members holding a testing reagent.
In further embodiments, the test strip includes a third layer next to the wicking member for providing support to the wicking member. Other features include capillary transfer passages comprising a hole, channel, or other shape to control sample flow rate.
Another aspect of the present invention provides a sample testing device, which includes a housing having a plurality of openings, and a test strip as described above, wherein each of the testing members viewable through at least one of the plurality of openings of the housing.
Advantageously, the present system provides a test strip that separates the testing member holding the testing reagent from the sample holding member itself. Thus, providing a simpler testing process which helps prevent unsanitary conditions and cross-contamination. The test strip can be placed into a carrier device or instrument to assist in handling and containing the sample being tested, such as urine, blood, body fluids or any other type of sample extraction. The present invention makes the testing process easier, more sanitary, and less confusing when processing multiple samples.
BRIEF DESCRIPTION OF THE DRAWINGS
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.
Capillary transfer plane member 102 is adhesively attached to one side of the first layer or wicking member 101. It is located so that it is coplanar with the wicking member and sandwiched between the first layer and the testing members 108-112. In one embodiment, the wicking member is longer than the capillary transfer plane member so that sample application area 115 of wicking member 101 is exposed so that a sample can be placed thereon. In one embodiment, capillary transfer plane member 102 is fabricated from Mylar or other suitable material.
Member 102 includes a plurality of capillary transfer passages 103-107.
These passages provide a capillary force action to draw a portion of a sample placed on wicking member 101 to be drawn upwards through the passage and into contact with the testing members 108-112. Each of the capillary transfer passages are of a suitable size for providing correct flow rate of the sample. In one embodiment, the passages are holes of approximately 0.5 to 2.5 millimeters in diameter. In another embodiment, each passage is a hole approximately 2 millimeters in diameter. Those skilled in the art will appreciate that the exact size of the hole is determined by the viscosity of the liquid and the desired flow rate. Moreover, it is noted that if the passage is too small, surface tension of the sample fluid will prevent flow and if the passage is too large, the capillary action will not be activated. Alternatively, the passages can be channels, such as channels 801-805 shown in
Furthermore, more than one hole, channel, or other shaped passage may be located under each test area, as shown in
The present invention is not limited by the size of the layers, and those skilled in the art will appreciate that a variety of sizes are within the scope of the present invention. However, by way of example, but not limitation, in one embodiment, the first layer, such as wicking member 101, is approximately 70 millimeters long by 5 millimeters wide and 0.20 millimeters thick. Also, way of example, but not limitation, in one embodiment, member 102 is approximately 56 millimeters long by 5 millimeters wide and 0.50 millimeters thick.
Testing members 108-112 are testing areas or test pads which are fabricated from porous materials that will hold specific testing reagents. The testing reagents in the testing members 108-112 can provide for separate testing of a single sample. In one embodiment, the testing members can include a color-coded, positive or negative, test result. The testing members are located over the capillary transfer passages 103-107 in the capillary transfer plane member 102. In one embodiment, member 102 includes adhesive zones 601-605 for attaching testing members 108-112 over its capillary transfer passages 103-107 (see
As a sample flows along the wicking member 101, some of the sample will be pulled through the first capillary transfer passage 103 and saturate the first testing member 108. As noted above, the capillary transfer passages 103-107 are shaped and designed a suitable size for providing correct flow rate of the sample. The sample will continue on to each adjacent capillary transfer passage 104-107 in the same manner until it reaches the absorbent area 113. This system provides that a user need only add a few drops to the application area 115. This lessens the complexity of doing multiple tests since there is no need to carefully time the immersion of the test strip in the fluid sample. Also, since immersion is not required, the present system provides for a neater, more sanitary testing system.
As will be recognized by one skilled in the art, the present invention relates generally to any dipstick format test whereby the sample must be introduced to the testing area by submerging the dipstick into the sample being tested or have the sample introduced directly onto the test areas. Advantageously, the lateral flow test strip 100 placed within the carrier device 1200 provides that a sample can be tightly controlled, isolated and identified, even after introducing the sample into the sample application area 115. For example, if multiple samples are being tested, as is the case in a laborator, environment, it is difficult to efficiently identify multiple samples from different patients once the samples are removed from a collection cup. Advantageously, in the present system, the lateral flow test strip in a carrier device provides an area for permanent and efficient sample/patient identification. Moreover, the present system can be used for the conversion of adulterant or urinalysis dipsticks that screen for adulterants in urine samples or uranalysis tests that screen for Ph factors, for example.
CONCLUSIONA sample testing system has been described. In one embodiment, the system includes a test strip 100 for testing a sample. Test strip 100 having a first layer, such as a wicking member 101, for holding and carrying the sample. The test strip includes a second layer next to the first layer comprising a capillary transfer plane member 102 having a plurality of capillary transfer passages 103-107 for drawing a portion of the sample away from the wicking member 101. The test strip also includes and a plurality of testing members 108-112, each testing member located over at least one of the plurality of capillary transfer passages, each testing member 108-112 for receiving the portion of the sample from the capillary passage(s) beneath the testing member. In one embodiment, the wicking member 101 comprises a first end having a sample application area 115 and a second end comprising an absorbent area 113. In one embodiment, the capillary transfer passages comprises a hole of approximately 0.5 to 2.5 millimeters in diameter. Alternatively, the capillary passage can be shaped as a channel, star, or other shape to provide the correct flow depending on the flow rate desired by the designer. Each of the plurality of testing members 108-112 comprise a porous material holding a testing reagent.
In another aspect, the present system provides a lateral flow test strip 100 that can be placed into a carrier device 1200 or instrument to assist in handling and containing the sample being tested, such as urine, blood, body fluids or any other type of sample extraction. The lateral flow test strip 100 provides a method for converting any type of dipstick style test, such as adulterants, glucose, urinalysis, etc. to an easy and sanitary format by enclosing and controlling the sample. The present invention makes the testing process easier, more sanitary, and less confusing when processing multiple samples.
It is understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
1. A test strip, comprising:
- a first layer;
- a second layer located next to the first layer, the second layer comprising a capillary transfer plane member having a plurality of capillary transfer passages; and
- a plurality of testing members, each testing member located over at least one of the plurality of capillary transfer passages.
2. The test strip of claim 1, wherein the first layer comprising a wicking member.
3. The test strip of claim 1, further comprising a third layer, the third layer located next to the first layer, the third layer comprising a backing member.
4. The test strip of claim 1, wherein each of the plurality of capillary transfer passages comprises a hole.
5. The test strip of claim 1, wherein each of the plurality of capillary transfer passages comprises a channel.
6. The test strip of claim 1, wherein the first layer comprises a wicking member, the wicking member comprising a first end having a sample application area and a second end comprising an absorbent area.
7. The test strip of claim 1, wherein each of the plurality of testing members comprise a porous material holding a testing reagent.
8. The test strip of claim 1, wherein each of the capillary transfer passages comprises a hole of approximately 0.5 to 2,5 millimeters in diameter.
9. The test strip of claim 1, wherein each of the capillary transfer passages comprises a hole of approximately 2 millimeters in diameter.
10. A test strip for testing a sample, comprising:
- a first layer for holding the sample;
- a capillary transfer plane member having a plurality of capillary transfer passages, each capillary transfer passage for drawing a portion of the sample away from the first layer; and
- a plurality of testing members, each testing member located over at least one capillary transfer passage, each testing member for receiving the portion of the sample from the capillary passage(s) beneath the testing member.
11. The test strip of claim 10, wherein the first layer comprises a wicking member.
12. The test strip of claim 11, wherein each of the capillary transfer passages comprises a hole of approximately 0.5 to 2.5 millimeters in diameter.
13. The test strip of claim 11, wherein each of the plurality of capillary transfer passages comprises a channel.
14. The test strip of claim 11, further comprising a backing member for providing support to the wicking member.
15. The test strip of claim 11, wherein the wicking member comprises a first end for applying the sample to the test strip and a second end comprising an absorbent area for causing the sample to flow down the wicking member.
16. A test strip for testing a sample, comprising:
- a first layer comprising a wicking member for carrying the sample, the wicking member comprising a first end having a sample application area and a second end comprising an absorbent area;
- a second layer attached to the first layer and coplanar with the first layer, the second layer comprising a capillary transfer plane member having a plurality of capillary transfer passages, each capillary transfer passage for drawing a portion of the sample away from the wicking member; and
- a plurality of testing members, each testing member located over at least one of the plurality of capillary transfer passages, each of the plurality of testing members comprise a porous material holding a testing reagent.
17. The test strip of claim 16, wherein each of the capillary transfer passages comprises a hole of approximately 0.5 to 2.5 millimeters in diameter.
18. The test strip of claim 16, wherein each of the plurality of capillary transfer passages comprises a channel.
19. The test strip of claim 16, further comprising a backing member for providing support to the wicking member.
20. A sample testing device, comprising:
- a housing having a plurality of openings; and
- a test strip located within the housing, the test strip comprising: a first layer; a second layer located next to the first layer, the second layer comprising a capillary transfer plane member having a plurality of capillary transfer passages; and a plurality of testing members, each testing member located over at least one of the plurality of capillary transfer passages, each of the testing members viewable through at least one of the plurality of openings of the housing.
21. The test strip of claim 20, wherein the first layer comprises a wicking member, the wicking member having a first end comprising a sample application area and a second end comprising an absorbent area, the sample application area accessible through one of the plurality of openings in the housing.
22. The test strip of claim 20, wherein each of the plurality of testing members comprise a porous material holding a testing reagent.
23. The test strip of claim 20, wherein each of the capillary transfer passages comprises a hole of approximately 0.5 to 2.5 millimeters in diameter.
24. The test strip of claim 20, wherein each of the capillary transfer passages comprises a channel.
25. A method of performing a test of a sample, the method comprising:
- providing a test strip having a wicking member and at least one testing member, wherein the wicking member and the at least one testing member are separated by a member having a plurality of capillary transfer passages; and
- depositing the sample onto the wicking member of the test strip.
Type: Application
Filed: May 20, 2005
Publication Date: Sep 22, 2005
Applicant: Medtox Scientific, Inc. (St. Paul, MN)
Inventors: Mitchell Owens (Greensboro, NC), Norman Reddick (Liberty, NC), Michael Turanchik (Gibsonville, NC)
Application Number: 11/134,641