Abstract:
Devices and methods for collecting a fluid specimen and testing it are disclosed that avoid unduly exposing the tester to the specimen and eliminate the possibility of contaminating the remaining portion of the collected fluid. The device includes a first compartment for collecting the fluid and provides controlled volumes of fluid from the first compartment to a second compartment where the fluid is accessible to test strips. Fluid from the first compartment is transferred to the second compartment by use of a fluid metering valve having a valve cylinder with one or more wells formed on the surface of the cylinder. The fluid metering valve is fluidly connected to the first compartment at a first valve position and is fluidly connected to the second compartment at a second valve position.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates generally to fluid specimen containers and analytical testing methods for analyzing the contents of fluid specimens and, more specifically, to fluid specimen containers designed to transfer fluid to test strips or other containers for testing purposes.  
         BACKGROUND OF THE INVENTION  
         [0002]    Analysis of body fluids such as urine or blood typically involves a first step of collecting the fluid sample in a container and then removing a sample of the fluid from the container to analyze it in the desired test format. For example, the fluid is removed from the container using a pipette and is then applied to a chemical or immunoassay test strip. A serious problem with this approach is that the tester may become exposed to the bodily fluid during the removal or pipetting procedure and may become infected with agents contained in the fluid.  
           [0003]    A variety of fluid collection devices have been devised to limit tester exposure by combining the test component with the container (see, e.g. U.S. Pat. Nos. 4,827,944; 4,976,923; 5,119,830; 5,595,187; 5,501,837; 5,429,804; and 6,974,606). These devices, however, have various design limitations. For example, in some designs, testing occurs immediately rather than when actually desired. In other designs, the tests are built into the lid of the container, requiring inversion of the device to enable the specimen to exit the storage compartment and contact the test component. Inverting the device, however, raises the possibility for accidental leakage and makes it difficult to control the volume of fluid that is released to the test strip. Such designs also have the potential to contaminate the main fluid compartment with test reagents that flow backward from the testing compartment.  
           [0004]    Thus, a need exists for improved specimen fluid collection devices that provide controlled volumes of fluid to the test strips when desired, eliminate contamination by back flow, and avoid unduly exposing the tester to the liquid specimen.  
         SUMMARY OF THE INVENTION  
         [0005]    The present invention is directed to solving the problem alluded to above. Briefly, the device comprises: (a) a first compartment for receiving a fluid specimen to be tested and including a cover lid for fluidly sealing the first compartment; (b) a fluid metering valve comprising an assembly bearing and a valve cylinder disposed therein and rotatable along its longitudinal axis, said cylinder having one or more wells formed on the surface of the cylinder, said wells in fluid connection with said first compartment when said valve is at a first valve position; and (c) a second compartment in fluid connection to said wells of said valve cylinder when said valve is at a second valve position, said second compartment designed to receive one or more reagent test strips for testing the specimen fluid.  
           [0006]    Also provided are a variety of valve cylinder well designs, including use of multiple wells, variations in well positioning, variations in well dimensions and combinations of the above.  
           [0007]    In another embodiment, the device comprises at least one additional fluid metering valve in fluid connection with the first compartment when said additional valve is in a first position and is in fluid connection with at least one additional second compartment when the additional valve is at a second valve position.  
           [0008]    In other embodiments, fluid connection between the valve cylinder and the first or second compartment can be achieved by means of a passageway.  
           [0009]    In yet another embodiment, the fluid metering valve is located within a support structure. The second compartment also may be formed within the support structure.  
           [0010]    In other embodiments, access to the second compartment is controlled by a protective cover.  
           [0011]    The device also may comprise: (a) a first compartment for receiving a fluid specimen to be tested and including means for fluidly sealing the first compartment; (b) a second compartment designed to receive one or more reagent test strips for testing the fluid specimen; (c) a fluid metering valve comprising a valve cylinder disposed therein and rotatable along its longitudinal axis, said cylinder having one or more wells formed on the surface; and (d) means for fluidly connecting the fluid metering valve to said first compartment at a first valve cylinder position and to said second compartment at a second valve position.  
           [0012]    This device includes additional embodiments similar to those described above.  
           [0013]    Also provided herein is a method for using the device to collect and test a fluid specimen. The method comprises using one or more reagent test strips that avoids exposing the tester to the collected fluid and contaminating the collected fluid with the test strips, the method comprising the steps of: (a) collecting a fluid specimen into the first compartment of the device of the present invention; (b) rotating the cylinder of the fluid metering valve of the device to a first valve position so that the one or more wells connected to the first compartment each fill with a volume of the fluid specimen suitable to perform the testing; (c) rotating the cylinder of the fluid metering valve following step (b) to the second valve position so that the one or more wells are connected to the second compartment; and (d) inserting the one or more test strips into said second compartment so that each test strip contacts a suitable volume of fluid accessible to the second compartment and thereby initiating the test, wherein a fluid specimen is tested using one or more reagent test strips.  
           [0014]    In another embodiment, the method is used to measure the presence or amount of an analyte by immunoassay while in another embodiment, the fluid tested is urine.  
           [0015]    These and still other embodiments are discussed in more detail below. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    The various features and advantages of the present invention will become more clearly appreciated as a detailed description of the preferred embodiment is given with reference to the appended drawings.  
         [0017]    [0017]FIG. 1 is a perspective side view of a sketch of the fluid collecting and testing device with lid, first chamber for collecting fluid, fluid metering valve, test card and removable protective cover. Valve cylinders of the fluid metering valve also are shown with variation in well arrangements and dimensions.  
         [0018]    [0018]FIG. 2 is a vertical sectional view substantially along the line  2 - 2  in FIG. 1, showing interior details of the fluid collecting and testing device including the first compartment, fluid metering valve, second compartment and a passageway providing a connection for fluid between the valve and the second compartment.  
         [0019]    [0019]FIGS. 3A and 3B are horizontal sectional views taken substantially along the line  3 - 3  in FIG. 1. The relationship of the fluid metering valve to the passageway linking to the second compartment is shown. FIG. 3A shows a valve cylinder having multiple wells and multiple separate passageways connecting to separate troughs at the bottom of the second compartment. FIG. 3B shows a valve cylinder having a single longitudinal well aligning with a single passageway connecting to the second compartment.  
         [0020]    [0020]FIG. 4 is a vertical sectional view of the fluid collecting and testing device similar to that shown in FIG. 2. In FIG. 4, two fluid metering valves are shown, each directly connecting to a separate passageway which connects to a separate second compartment.  
         [0021]    [0021]FIG. 5 is a vertical sectional view of the fluid collecting and testing device similar to that shown in FIG. 2. In FIG. 5, a single fluid metering valve is shown directly connecting with separate passageways each connecting to a separate second compartment.  
         [0022]    [0022]FIG. 6 is a vertical sectional view showing interior details of the fluid collecting and testing device similar to that shown in FIG. 2. In FIG. 6, the fluid metering valve is located below the bottom of the first compartment and the valve is connected directly to the passageway.  
         [0023]    [0023]FIG. 7 is a vertical sectional view of the fluid collecting and testing device that is similar to FIG. 2. In FIG. 7, the passageway is eliminated, providing direct access of the test card or test strip to the wells of the valve cylinder through the second compartment.  
         [0024]    [0024]FIG. 8 is a side view of the fluid collecting and testing device that is similar to FIG. 2. In FIG. 8, the second compartment is configured in a different relation to the first compartment and the fluid metering cylinder is connected directly to the passageway.  
         [0025]    [0025]FIG. 9 is a perspective view showing a fluid collection and testing device similar to FIG. 1. In FIG. 9, the device includes an integral protective cover for the second compartment and a cap for the cover. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0026]    Provided herein is a fluid specimen collecting and testing device and methods for using same. The device is suitable for collecting and testing any fluids, however, the fact that the tester is not appreciably exposed to the collected fluid makes the device particularly suited for the collection and testing of animal body fluids, particularly body fluids from a human. Any body fluid can be collected for testing with the device including, for example, urine, whole blood, blood serum or blood plasma. It will be readily apparent to those skilled in the art that the disclosed device and methods are suitable for testing of other fluid samples such as river water, pool water, ocean water and the like.  
         [0027]    It also will be understood that one can test a body solid (e.g. a stool) or any other solid with the device provided the body solid undergoes processing to generate a fluid specimen. Methods to solubilize or extract a soluble fraction from a solid specimen such as by use of detergents, denaturants or other agents are well known in the art. The body solid is preferably collected and processed to generate a fluid specimen before the fluid specimen is added to the collection and testing device.  
         [0028]    A preferred embodiment of the present fluid collecting and testing device  10  is shown in FIG. 1. It comprises a first compartment  12  for collecting and storing fluid to be tested and a lid  14  for sealing the fluid within the first compartment. The lid may be fluidly sealed to the top of the first compartment by methods well known in the art including, for example, use of matching screw threads on the outside top of the first compartment and the inside lip of the lid. FIG. 1 also shows an opening to a second compartment  16  formed outside of first compartment  12  and in support structure  18 , which also forms the base  19  of first compartment  12 . Fluid metering valve  20  with wells formed thereon  22  is shown partially contained within support structure  18 .  
         [0029]    Valve  20  has a short narrow extension  24  at one end which is accessible to the outside of the device and is used to rotate the valve. The extension may extend from the device or be within a recessed area in the body of the cylinder. All that is required is to provide a means for the user to be able to turn the cylinder. Below the collecting device depicted in FIG. 1 are various embodiments of valve cylinders  26 . The valve cylinders varying in well arrangements and well dimensions. As indicated in the figure, a cylinder can have one or more rows of wells, each row of a similar dimension and forming a single line along the longitudinal axis of the cylinder. Separate rows may be situated at opposite positions on the cylinder surface (i.e., 180° from each other) or may be situated closer together. In addition, a cylinder may have more than two rows of wells.  
         [0030]    Rows on a cylinder may vary in dimension from round to elongated in shape and in the volume of liquid that they hold. A cylinder also may have a row of wells where each well has a different dimension. The wells of a cylinder also need not be spaced in a single line. By spacing at different positions, fluid is delivered from each well to the second compartment at different valve position. A well also can be in the form of a trough that extends along the longitudinal axis of the cylinder. Clearly, one of ordinary skill can readily envision a variety of cylinder designs with combinations of wells and rows not shown in FIG. 1. The number of wells in a row of the cylinder also can vary.  
         [0031]    The fluid collection and testing device of the invention can be manufactured and sold with a single fluid metering valve installed in position and for ready use. Alternatively, or in addition, the device can be manufactured with the ability to remove and replace valve cylinders. In this case, the user may be provided with a selection of valve cylinders that are compatible with the device and can mount the cylinder of choice into the device before use.  
         [0032]    As shown in FIG. 1, the opening to second compartment  16  is designed to receive test unit  28  for testing fluid in the second compartment. Optional cover  30  can be applied to cover recessed area  32  of compartment  16  to protect the test unit when the device is used for testing.  
         [0033]    [0033]FIG. 2 is a vertical sectional view of the device showing the fluid metering valve  20  partly within support structure  18  including rotatable valve cylinder  26  seated within bearing assembly  34 . The portion of the bearing assembly  34  that is contained within support structure  18  can be integral to the support structure or can be made as a separate component. Valve cylinder  26  is shown with wells  22  formed as a depression on the surface of the cylinder, but not extending all the way through the diameter of the cylinder. The wells  22  of cylinder  26  take up a fixed volume of fluid from the first compartment  12  when the wells are in fluid connection with the first compartment. Fluid connection is accomplished as shown in FIG. 2 by positioning the valve cylinder at a first position where the cylinder well  22  is aligned with opening  36  in bearing assembly  34 . Bearing opening  36  may be a single longitudinal opening that provides access to all the wells of a cylinder row at the same time. Alternatively, there may be multiple bearing openings in the bearing, each opening aligning with and providing fluid access with a well of the cylinder.  
         [0034]    Once fluid from compartment  12  passes through the valve assembly opening  36  and fills wells  22 , the fluid metering valve is rotated to a second position where well (shown as  38 ) is in fluid connection with the second compartment  16 . Fluid connection occurs when fluid leaves well  38  and flows via passageway  40  through second compartment access hole  42  (positioned as a low point in the compartment relative to the cylinder to allow the fluid leaving the well  38  to flow by gravity to compartment  16 ). Fluid entering second compartment  16  collects at the bottom of compartment  44 .  
         [0035]    [0035]FIGS. 3A and 3B are horizontal sectional views of the fluid testing device looking down through the opening of the first compartment. The relationship of the fluid metering valve  20  to passageway  40  linking to second compartment  16  is shown. FIG. 3A shows a valve cylinder having multiple wells  22 , multiple passageways  40  connecting to separate troughs  46  at the bottom  44  of the second compartment  16 . The separation into troughs  46  at the bottom  44  of second compartment  16  is spaced to allow receipt of separate test devices such as separate test strips mounted on a single test card. The number of troughs normally should match the number of wells in a single row of the valve cylinder.  
         [0036]    [0036]FIG. 3B shows a valve cylinder having a single longitudinal well  22  aligning with a single passageway  40  connecting to the bottom of second compartment  16 . Thus, in this case, there is a single well and a single trough at the bottom of the second compartment.  
         [0037]    The purpose of the first compartment is for fluid collection and retention. The purpose of the second compartment  16  varies with the embodiment. In some embodiments, the second compartment  16  serves provide access for a test strip or test card to reach the fluid at the bottom of the second compartment which has collected there following distribution through the fluid metering valve  20 . In other embodiments, the second compartment serves to provide access for a test strip or test card to reach fluid within the wells of the cylinder. In yet another embodiment, the second compartment  16  serves to hold fluid collecting containers.  
         [0038]    [0038]FIG. 4 depicts an embodiment having a single first chamber  12  and two separate fluid metering valves  20 , each connecting to a separate second chamber  16 . In this case, fluid connection occurs when the metering valve is in a second valve position. At this point, fluid in wells  38 , passing through opening  36  of bearing  34 , flows via a separate passageway  40  to collect in a separate second compartment  16 . Thus, the same device can be used to run two assay tests at the same time.  
         [0039]    [0039]FIG. 5 shows an alternative embodiment where a single first chamber  12  connects to two second chambers  16  by a single fluid metering valve  20 . Passageway  40  in FIG. 5, although shown nearly level to bearing opening  36 , still must direct fluid on a downhill path to second compartment  16  in order to take advantage of gravity. One skilled in the art can readily appreciate additional embodiments involving one or more fluid transfer valves in conjunction with one or more second compartments.  
         [0040]    [0040]FIG. 6 is a vertical sectional view of an embodiment of the invention where fluid metering valve  20  is positioned fully within the support structure  18 . In this case, an opening  48  is provided in bottom  19  of first compartment  12 . Opening  48  connects to passageway  50  in the support structure, which connects to opening  36  in valve bearing  34 . Thus, when the fluid metering valve is in a first valve position, the well  22  of cylinder  26  aligns with the opening  36  in valve bearing  34 , thus placing the well of the metering valve in fluid connection with the first chamber. There may be a separate opening  48  connecting to a separate passageway  50  for each opening  36  in the valve bearing  34 . Alternatively, opening  48  may be a single long trough-shaped opening connecting via a single passageway  50  to each opening in the valve bearing. Clearly different arrangements are possible depending on the valve cylinder well arrangement chosen.  
         [0041]    [0041]FIG. 7 is a vertical sectional view of an embodiment of the invention where the second compartment  16  is directly connected to the wells  22  of fluid metering valve  20 , thus providing fluid connection without the use of a passageway. In this design, when the valve is in a first position, fluid from the first chamber  12  passes through opening  36  in valve bearing  34  to fill well  22 . When the metering valve is rotated to a second valve position, fluid connection is provided to the second chamber  16 . At this point, test device  28  can be inserted into the second chamber  16  and directly contact fluid within the wells  38  of cylinder  26 .  
         [0042]    [0042]FIG. 8 is a side view of an embodiment of the invention showing second compartment  16  positioned nearly horizontal with respect to its position in FIG. 2, where it is shown in an essentially vertical position. It is appreciated that second compartment  16  may be located anywhere between a vertical position and a horizontal position provided that at the second metering valve position, fluid exists the wells and flows to bottom of  16  where it is retained.  
         [0043]    The second compartment  16  also can have any number of sizes and shapes For example, the second compartment  16  can be designed with contours that follow the shape of test card  28 . The second compartment also may be much larger than the shape of a test card. In this latter embodiment, the device can be configured such that the second compartment is below the first compartment and the test card  28  can be placed horizontally within the second compartment  16  below the cylinder so as to receive fluid that is released from wells of the cylinder. Alternatively, in this design, the second compartment  16  can hold one or more fluid containers such as a tube or a plate with wells, positioned to receive the fluid released from the valve cylinder wells. The fluid container or plate with wells can be removed from the device and tested elsewhere.  
         [0044]    [0044]FIG. 9 is a perspective view showing an alternative embodiment of the protective cover design shown in FIG. 1. In this case, opening to second chamber  16  is enclosed within a protective compartment  52  having an opening at top  54  and a cover  56 . Thus, when using this device, lid  14  and cover  56  are removed, test unit (not shown: e.g. test strip or test card) can be inserted through opening  54  and into second compartment  16 .  
         [0045]    Generally the fluid collecting and testing device  10 , can be sterilized as a whole or can be separated into a lid and fluid container which are separately sterilized and packaged. Preferably the entire device with the lid attached is sterilized and stored in a sterile package.  
         [0046]    The present invention provides methods to collect and test a fluid specimen using one or more reagent test strips in conjunction with the collecting and testing device disclosed herein. Body fluid to be tested can be collected from any animal, preferably from a human by standard methods. In the case of human body fluids, the donor may collect his/her own urine specimen while the assistance of a professional should generally be used if blood is collected. If an anti-coagulant agent is used to collect the blood, plasma is obtained following centrifugation and pelleting of blood cells. If no anti-coagulant is used, the blood is allowed to clot and the serum is separated from the clot using standard methods such as centrifugation. Blood plasma or serum thus obtained can be added to the first compartment  12  of the device  10  with our without dilution. Alternatively, whole blood collected with anti-coagulants may be added to the first compartment  12  of the collecting and testing device  10  and tested using test strips or test cards designed for use with whole blood (see, e.g., U.S. Pat. No. 6,036,919).  
         [0047]    In the case of human urine, the fluid donor can remove the testing device lid  14  and discharge urine into the first compartment  12 . Afterwards, the lid  14  is affixed in fluid-tight relationship thereon such as by screw threads or other attachment means. The collected fluid can now be tested or may be stored in the device for later testing. The simplicity of the device and the ease of using reagent test unit (e.g. test strip or test card) allows testing to be conducted in the office or in the laboratory.  
         [0048]    To initiate testing, in general, the fluid metering valve is rotated to a first position where wells are in fluid connection with fluid in the first compartment. A tab  24  at the end of the cylinder  26  (see FIG. 1) assists the operator in rotating the valve cylinder within its seat assembly  34  (see FIG. 2). Once the wells are filled, the cylinder of the metering valve is rotated to a second valve position where the filled wells are in fluid alignment a second compartment  16  via passageway  40  (see FIG. 2).  
         [0049]    As shown in many of the figures, a test unit is positioned in the second compartment so that each test contacts a suitable volume of fluid at the bottom of the compartment to properly initiate and complete the test. A test unit is typically a single test strip or a card containing multiple test strips affixed.  
         [0050]    Test strips using immunoassay technology to detect the presence of a particular analyte in the fluid can be used individually or attached to a card or solid backing made, for example, from cardboard or plastic as is well known in the art. Immunoassay test strips can be of any format including direct binding, competition as well as double or single antibody assays. Individual test strips and cards with multiple test strips attached can be prepared by methods well known in the art (see, e.g. Carlberg, IVD Technology, vol. 5(no.3), p46, May/June 1999, U.S. Pat. Nos. 5,141,850, 5,976,895, 5,770,458, and 6,036,919). Test strips whereby analyte detection involves visualization of colloidal gold or colored particles such as latex are preferred.  
         [0051]    The test strip or card with test strips also can contain one or more chemical patches, each of which changes to a degree of color indicative of a characteristic of the test fluid. For example, in the case of pH testing, one of the patches will change to a particular color, or shade of color, depending upon a pH level of the test fluid. Chemical test patches for measuring pH, protein, glucose, ketone, bilirubin, blood and urobilinogen among others are well known in the art. A test card also can contain a mixture of test strips including immunoassay test strips as well as test strips with chemical patches.  
         [0052]    When the test unit is properly inserted into the second compartment, the bottom end of the test strip contacts fluid at the lower end of the second compartment. The fluid is drawn along the reagent test strip until it comes to bands of the chromatographic immunoassay test reagent where a color change can occur to perform the desired test. One can visualize the test results while the test strips are positioned in the second compartment or the test card may be removed from the device after contacting the fluid and be read at a later time.  
         [0053]    The invention thus has been disclosed broadly and illustrated in reference to representative embodiments described above. Those skilled in the art will recognize that various modifications can be made to the present invention without departing from the spirit and scope thereof. All publications, patent applications and issued patents, are herein incorporated by reference to the same extent as if each individual publication, patent application or issued patent were specifically and individually indicated to be incorporated by reference in its entirety