Device and method for collecting and testing fluid specimens

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.

What is claimed is:  
     
         1 . A device for specimen fluid collection and for testing the fluid with reagent test strips, said device comprising: 
 (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 valve cylinder disposed therein and rotatable along its longitudinal axis, said cylinder having one or more wells formed on the surface, said wells in fluid connection with said first compartment when said valve cylinder 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 fluid specimen.    
     
     
         2 . The device of  claim 1  wherein said cylinder of said fluid metering valve contains multiple wells.  
     
     
         3 . The device of  claim 2  wherein said multiple wells of said cylinder form a single line running parallel with the longitudinal axis of the cylinder such that all of the wells will fill with fluid and discharge the fluid at a single valve position.  
     
     
         4 . The device of  claim 3  wherein said cylinder of said fluid metering valve contains more than a single line of wells.  
     
     
         5 . The device of  claim 2  wherein said multiple wells of said cylinder are spaced out of alignment with each other such that each of the wells will fill with fluid and discharge fluid at a different valve position from the other wells.  
     
     
         6 . The device of  claim 2  where said multiple wells of said cylinder differ in the volume of fluid that can be contained in the well.  
     
     
         7 . The device of  claim 2  wherein said well of said cylinder is formed in the shape of a trough running along the longitudinal axis of the cylinder.  
     
     
         8 . The device of  claim 1  wherein said device further comprises at least one additional fluid metering valve in fluid connection with said first compartment when said additional cylinder valve is in a first position and in fluid connection with at least one additional second compartment when said additional valve cylinder is at a second valve position, wherein said additional second compartments are each designed to receive one or more reagent test strips for testing the fluid.  
     
     
         9 . The device of  claim 1  wherein said first compartment is located above said second compartment.  
     
     
         10 . The device of  claim 1  wherein said wells of said valve cylinder at a second valve position and said second compartment are in fluid connection by means of a passageway.  
     
     
         11 . The device of  claim 1  wherein said wells of said valve cylinder at a first valve position and said first compartment are in fluid connection by means of a passageway.  
     
     
         12 . The device of  claim 1  wherein wells of said valve cylinder at a second valve position are directly accessible to the one or more reagent test strips inserted into the second compartment.  
     
     
         13 . The device of  claim 1  wherein said fluid metering valve is located within a support structure.  
     
     
         14 . The device of  claim 13  wherein said second compartment is formed within said support structure.  
     
     
         15 . The device of  claim 1  wherein access to the second compartment is controlled by a protective cover.  
     
     
         16 . A device for specimen fluid collection and for testing the fluid with reagent test strips, said device comprising: 
 (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.    
     
     
         17 . The device of  claim 16  wherein said fluidly connecting includes an assembly bearing within which the valve cylinder is disposed.  
     
     
         18 . The device of  claim 16  wherein said wells of said valve cylinder at a first valve position and said second compartment are fluidly connected by means of a passageway.  
     
     
         19 . The device of  claim 16  wherein said wells of said valve cylinder at a first valve position and said first compartment are in fluidly connected by means of a passageway.  
     
     
         20 . The device of  claim 16  wherein said cylinder of said fluid metering valve contains multiple wells.  
     
     
         21 . The device of  claim 20  wherein said multiple wells of said cylinder differ in the volume of fluid that can be contained in the well.  
     
     
         22 . The device of  claim 16  wherein said device further comprises at least one additional fluid metering valve in fluid connection with said first compartment when said additional cylinder valve is in a first position and in fluid connection with at least one additional second compartment when said additional valve cylinder is at a second valve position, wherein said additional second compartments are each designed to receive one or more reagent test strips for testing the fluid.  
     
     
         23 . The device of  claim 16  wherein wells of said valve cylinder at a second valve position are directly accessible to the one or more reagent test strips inserted into the second compartment.  
     
     
         24 . A method for collecting and testing a fluid specimen 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  claim 1;     (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.    
     
     
         25 . The method of  claim 24  wherein said one or more test strips measures the presence or amount of an analyte by immunoassay.  
     
     
         26 . The method of  claim 24  wherein said fluid is urine.