Abstract:
A fluid specimen testing device having a removable lid which carries at least one testing strip behind a transparent top viewing window. Testing is initiated by tilting the device into a stable sideways orientation to allow the specimen to contact the sampling pad portion of the strip. The device is adapted to provide stability in the upright, tilted and inverted orientations. A roll-inhibiting feature also acts as an indicator for proper roll positioning in the tilted configuration. The strips are also oriented in the lid so that they are substantially vertical when the device is in the tilted position thereby enhancing a condition for proper capillarity. The strip is carried close to the upper surface which allows it to be copied on a flat glass copier providing for more objective recordation of the test results.

Description:
FIELD OF THE INVENTION 
     This invention relates generally to fluid specimen containers, testing devices for conducting chromatographic reaction tests using assay testing strips for fluid specimens and more particularly to sealed receptacles for holding fluid specimens having testing capability. 
     BACKGROUND OF THE INVENTION 
     Fluid specimen jars or cups are commonly used to collect and test fluid specimens for the presence or absence of specific “indicators,” which show the presence of specific chemicals, hormones, antibodies or antigens and are most commonly used for drug and pregnancy testing, among other types of assay tests. 
     Collecting and testing fluid specimens carries a measure of health risk for the person conducting the test and contamination risk to the specimen or testing media. Testing devices have previously required that a specimen be placed in a specimen cup and that a technician manually insert and submerge a portion of a testing strip into the specimen then, withdraw it to read the results. With the potential for contact with the sample by the technician and its associated health and contamination risks, a sealed receptacle for preventing contact is desirable. Various means have been proposed for further reducing the risk of contact as shown in U.S. Pat. No. 4,976,923 to Lipsky et al, and U.S. Pat. No. 5,429,804 to Sayles, which utilize a one-step testing device, with chromatographic testing strips mounted in their lids. 
     Others, as shown in U.S. Pat. No. 5,119,830 to Davis propose a test strip adhered to the floor of the lid, covered with a frangible surface which when punctured allows contact with the specimen when the device is inverted. A mylar-type sheet encasing the test strip and the frangible portion, defining the test space and preventing outside contact with the specimen during testing. 
     Other devices like U.S. Pat. No. 5,976,895 to Cipkowski, provide means for avoiding inversion. However, such devices are limited in that only a pre-determined amount of specimen can be tested. Overfilling encourages contact between specimen, and technician, either during insertion of the testing card, or when the technician opens the container to empty a portion of the contents. There can also be the difficulty of locating a proper place for discarding of the excess specimen. Also, if the maximum fluid level is exceeded, test results will not be reliable as the testing process may be adversely affected if the sample contacts the test strip higher than the sampling pad&#39;s limit line. 
     Often, medical device manufacturers, do not make products geared for use by the lay person, unless so targeted. Recently, the use of specimen testing devices by other than health care professionals has increased. Due to the fact that these tests are increasingly performed and evaluated by relatively unskilled technicians, the device needs to be relatively simple to operate to ensure adequate exposure of the test strip and provide accurate results. Devices that require inversion and subsequent righting of the container to conduct the test, involve certain measure of skill to provide adequate submersion of the test strips. 
     U.S. Pat. No. 5,403,551 to Galloway, requires inversion to an unspecified angle, making gauging adequate submersion of the test strips difficult and uncertain. Further, testing chambers that allow the flow of a fluid-specimen onto a test strip upon inversion, also allow the sample to escape upon righting, which can affect submersion of the test strip by trapping air-bubbles, which can inhibit the capillary movement of a specimen up a test strip. Since capillary action can be adversely affected by trapped air, and the position and orientation of the test strips. Devices which place the strips in a horizontal orientation, hinders capillary movement. 
     A “splash-shield” mechanism is shown by U.S. Pat. No. 5,429,804 to Sayles, to prevent secondary contact of the specimen with the test strip prior to the initial submersion to prevent premature testing of a specimen. In these devices, proper subjection of the test strip sampling pad to the specimen therefore requires a skill which may be beyond that of an inexperienced technician, resulting in unreliable and often inaccurate results. The splash-shield can also interfere with the submersion of the testing strip by trapping air-bubbles. 
     Since these tests are widely used in the medical industry, the workplace, athletic competitions and law enforcement. There is a need for being able to conduct various assay tests in large quantities. However, since testing materials are typically disposable, this can be costly. Testing devices are costly due to materials and difficulty in manufacturing, and are therefore not practical for use by certain organizations or institutions having limited resources. 
     Examples of complicated and thus costly testing devices are demonstrated by U.S. Pat. No. 5,403,551 to Galloway, et al and U.S. Pat. No. 5,976,895 to Cipkowski, both of which require multiple components, increasing materials and manufacturing cost. Both also require specially designed cartridges that are only compatible with a specific type of container. 
     Presently, test results are viewed by examining the test strip directly or through the testing device itself and manually recorded by a technician. Therefore, the results can be very subjective and without proof after the test strip has been saturated and/or discarded. 
     Therefore, there is a need to ensure proper testing, by allowing each strip to be in continuous, but controlled contact with the fluid sample, to orient the test strips in the most efficient position to maximize capillary movement of the specimen, and to vent or prevent air-bubbles, making the testing device easy to operate and produce more reliable results than previous testing devices. 
     The invention results from a need to reduce the above-mentioned deficiencies in the art. 
     SUMMARY OF THE INVENTION 
     The principal and secondary objects of this invention are to provide a cost-effective fluid specimen testing device that can provide reliable results by preventing premature testing of the fluid specimen and proper testing by complete and continuous submersion of the testing strips&#39; sampling pads, and that can be easily used; and one in which results are recorded more objectively. 
     These and other valuable objects are achieved by a fluid specimen testing device having a removable lid, into which is mounted a testing strip behind a transparent top viewing window. Testing is initiated by tilting the device into a stable sideways orientation to allow the specimen to contact the sampling pad portion of the strip. The device is adapted to provide stability in the upright, tilted and inverted orientations. A roll-inhibiting feature also acts as an indicator for proper roll orientation in the tilted position. The strips are also oriented in the lid so that they are substantially vertical when the device is in the tilted position thereby enhancing a condition for proper capillarity. The strip is carried close to the lid&#39;s upper surface which allows it to be copied on a flat glass copier providing for more objective recordation of the test results. A specially adapted cavity allows enhanced uniformity in contact between multiple sampling pads and the specimen and discourages bubble formation and retention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a first embodiment of a fluid-specimen device according to the invention in a test orientation; 
         FIG. 2  is a perspective view of the device of  FIG. 1  in an upright orientation; 
         FIG. 3  is a cross-sectional view of the lid portion of the device of  FIG. 1  taken along line  3 - 3 ; 
         FIG. 4  is a perspective view of the device of  FIG. 1  in an inverted orientation on a photocopier; 
         FIG. 5  is a perspective view of a second embodiment of a fluid-specimen device according to the invention in an upright orientation; 
         FIG. 6  is a cross-sectional view of the lid portion of the device of  FIG. 5  taken along line  6 - 6 ; and 
         FIG. 7  is a flow-chart showing the method for recording a chromatographic assay test. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawing, there is shown in  FIGS. 1 through 4  a first embodiment of a fluid-specimen containing and testing device  1  having a cup portion  2  having a closed bottom end  3  and an opposite top opening  4  defining an inner chamber  5  for collecting a fluid specimen  6 , and a lid  7  sized and shaped to seal the opening by corresponding threading  8 . Other means well known in the art may be used to seal the lid to the cup. 
     As shown in  FIG. 2 , the bottom end  3  of the cup is flattened to allow it to rest on a substantially horizontal surface  9   a  in a stable, upright position and contain the specimen. The major axis  10  of the device is substantially vertical when the device is in an upright orientation. 
     The lid  7  has a substantially rigid, disk-shaped top portion  20  having a substantially planar outer, upper surface  17  and inner, lower surface  21 . A substantially cylindrical flange  22  extends downward from the periphery of the top portion having inner threads  23  commensurate with corresponding threads  24  on outer upper periphery of the cup. The lid  7  is preferably made from substantially rigid, durable, fluid impermeable and non-reactive plastic material such as polycarbonate, polyethylene, polypropylene, or acrylic, and is adapted to carry a number of chromatographic assay test strips  11  within dedicated oblong pockets  12  behind transparent windows  27 . An information carrying sticker  18  may be placed adjacent to the windows. 
     As shown in  FIG. 1 , the pockets  12  are positioned to orient the strips in a substantially vertical orientation when the device is in a tilted test orientation where the major axis  10  is substantially parallel to a horizontal support surface  9   b . A pair of roll inhibiting ears  13  extend radially from the flange of the lid to help stabilize the device and thus help prevent the test strips from rolling beyond their optimum vertical test orientation. The ears also maintain the device at a predetermined and optimum test angle, and act as a readily perceived indicator of the proper roll position when the test is initiated. Other means well-known in the art may be employed to inhibit rolling motion. Pitch motion is prevented by top  14   a  and bottom  14   b  surfaces of the device respectively. 
     It is an important feature of the invention to provide for easy and more objective recordation of the test results. This is accomplished by placing the strips within the device in an orientation in which the results shown thereon may be recorded by an objective, automated reader such as a photocopier, scanner, camera or other well known or future reading apparatus. Means are provided to stabilize the device in an inverted orientation as shown in  FIG. 4  when the device is resting on the horizontal glass surface  9   c  of a flat bed copier  15  where the major axis  10  is in a substantially inverted vertical orientation. In this embodiment three upper spaced apart portions  16   a ,  16   b ,  16   c  of the flat upper surface  17  of the lid form a plane and tripod support for the device in the inverted orientation. Additionally, the minimum distance D between the test strip and a photocopier contact surface CS is minimized so that precise recordation is accomplished. The distance will of course depend on the thickness of the viewing window, which will preferably range between about 1 and about 5 millimeters. 
     Referring now to  FIG. 3 , each strip  11  is mounted within an oblong pocket  12  formed into the lid  7 . The upper wall of the pocket is made from substantially transparent, fluid-resistant, non-reactive material to form a viewing window  27  between the pocket and the upper surface  17  of the lid allowing visual access to the strip. As shown in  FIG. 3 , the entire top portion and peripheral flange of the lid may be made from the same optically transparent material to reduce manufacturing costs. 
     The pocket  12  is formed by an oblong channel formed into the inner surface  21  and partially covered by a substantially planar backing  25  made of vinyl, foil, plastic, Teflon, or other fluid-impermeable and non-reactive sheet material having an attachment layer  26  of non-reactive, pressure sensitive adhesive. Such backings are commercially available from MBK Enterprises, Inc. of Chatsworth, Calif. Optionally, information may be printed on the adhesive side of the backing. 
     Partial covering of the channel thereby forms an aperture  30  through which extends the sampling pad portion  32  of the strip  11 . The aperture is sized and shaped to encircle the strip thus preventing over-saturation of the test strip, which can adversely affect the testing process. The backing completely covers the rest of the channel so that the aperture is the only effective opening of the pocket. Therefore the strip and any trapped air helps prevent flow of fluid into the pocket. A depression  37  is sized and shaped to enhance uniformity of exposure between the sampling pad  32  and the specimen by allowing controlled contact to both sides of the sampling pad. The depression also forms a venting region allowing the escape of air-bubbles from near the sampling pad which would disrupt specimen-to-pad contact and reduce test accuracy. 
     The oblong channel is formed during injection molding of the lid to further save manufacturing costs. The pocket is shaped and dimensioned to closely envelop the test strip  11  to enhance the predictable movement of fluid up the strip by capillarity alone. The strip is one of any number of commonly available chemical assay devices well known in the art which, in general, are made up of various porous materials for carrying chemical reagents specifically selected to test for the adequate presence of a chemical in the specimen. One end of the strip is a sampling pad  32  for contacting the specimen. The rest of the strip is constructed to establish a predetermined flow of the specimen from the sampling pad up through a conjugate region  33 , which conjugates the sought after chemical into one which is detectable, then through a membrane region  34  carrying test and control lines  35 , and a terminal absorbent pad  36 . Maintaining the substantially vertical orientation of the strips during testing helps prevent the fluid from contacting the strip above the sampling pad  32 , which can result in inadequate conjugation or otherwise interfering with the proper test sequence. 
     In  FIGS. 5 and 6  there is shown an alternate embodiment of the device wherein the lid  40  has a generally disk-shaped top portion  41  having an outer, upper surface  42  and inner, lower surface  43 . A substantially cylindrical flange  44  extends downward from the periphery of the top portion having inner threads  45  for attaching to the cup. The lid is generally formed from any type of rigid, durable, fluid impermeable and non-reactive material such as plastic. Unlike the previous embodiment, the material need not be transparent. In this embodiment a roll-inhibiting indentation  46  is set radially into a portion of the outer surface of the flange. 
     A generally disc-shaped valley  47  is formed into the outer surface of the lid. A channel  48  is formed into the bottom surface of the valley for each strip  50  to be carried by the lid. A generally disc-shaped transparent plate  51  fills the valley and covers the channels to form an individual pocket and a viewing window  52  for each strip. A layer of adhesive  53  or other means bond the plate to the bottom surface of the valley. The remaining peripheral ring of the upper surface  42  provides three upper spaced apart portions  54   a ,  54   b ,  54   c  which form a plane and tripod support for the device in the inverted orientation. Therefore, the thickness T of the plate is less than the depth D′ of the valley so as to not interfere with the spaced apart portions. Again, the minimum distance D between the test strip and a scanner or photocopier contact surface is minimized so that precise recordation is accomplished. 
     As with the previous embodiment, the pocket formed by each covered oblong channel is sized and shaped to envelop the strip and allow for a aperture  55  through which extends the sampling pad portion  56  of the strip  50 . A depression  57  is sized and shaped to enhance uniformity of exposure between the sampling pad  56  and the specimen by allowing controlled contact to both sides of the sampling pad. A divot  58  having a generally rounded shape and smooth surface is formed into the inner surface of the lid adjacent to the depression to further allow for the escape of air bubbles when the device is tipped into the tilted test orientation. 
     Optionally, the upper surface of the plate  51  is coated with a layer  59  of anti-reflective chemical coating material to reduce reflected light by about 98 percent, and hydrophobic material to lessen finger smudges thereby enhancing accurate recordation by reducing unwanted reflection and blurring. Such coatings are available from DENTON VACUUM, INC., of Moorestown, N.J. Alternately, other means such as lightly sanded upper surface may be used to reduce unwanted reflections. 
       FIG. 7  is a flow-chart diagram demonstrating the preferred method for conducting an immunological assay test and making a permanent record of the results by photocopying the external surface of the lid. A fluid-specimen is collected  60  in a container by removing the lid, placing the specimen in the jar portion, and replacing the lid. A test is then conducted  61  by tipping the container to a predetermined angle whereby the fluid-specimen is allowed to contact a testing strip carried in the lid. The test is preferably conducted by merely placing the container in a tilted orientation on a flat surface so that a roll-inhibiting means stabilize the container, and waiting for a period of time sufficient to allow the test results to appear. Once testing is complete, the container is placed  62  in an orientation readable by an automated reading device. If the reader is a photocopier, the container is placed in an inverted orientation on the horizontal copier surface, the n performing  63  a read operation by taking a copy to create a permanent and objective record of the test results. 
     In this specification the term “transparent” means that the material will not significantly hamper the ability to read the results displayed or carried on the test strips. 
     Although the preferred embodiments disclose a generally cylindrical container, those skilled in the art will readily appreciate other non-cylindrically shaped containers or specimen carriers and lids which do not depart from the invention. 
     While the preferred embodiments of the invention have been described, modifications can be made and other embodiments may be devised without departing from the spirit of the invention and the scope of the appended claims.