Patent Publication Number: US-2004052684-A1

Title: Diagnostic kit and method of using same

Description:
RELATED PATENT APPLICATIONS  
     [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/244,133 Entitled “Diagnostic Device and Method of Using Same”, filed on Sep. 14, 2002. 
    
    
     
       BACKGROUND OF THE INVENTION  
       [0002] The present invention relates generally to clinical diagnostic testing devices and, more particularly, to clinical diagnostic testing kits as utilized by physicians in their offices.  
       [0003] It is recognized that in the case of many pathological conditions, early identification and treatment can substantially reduce subsequent patient suffering. In this regard, testing of female vaginal samples has become recognized as important to the health of a patient.  
       [0004] The problem of vaginitis is one of the most common complaints bringing patients to physician&#39;s offices or clinics. The diagnosis is made after examination of vaginal fluid and testing of fluid pH, and a microscopic examination of the fluid.  
       [0005] In order for the test be competently performed, the pH of the fluid should be measured. Changes in pH can be visually observed. For example, a vaginal pH sampler, having pH paper mounted at the end of a plastic stick can be used to sample the vagina directly, While the stick has some utility, it presents a waste management problem after use, as the clinician attempts to dispose of it. In addition, the stick is limited in use solely for pH detection.  
       [0006] “Wet mount” tests follow as microscopic examination follows pH determination. The fluid is treated with potassium hydroxide (KOH) and the fluid/reagent mix is examined under the microscope for the presence of yeast cells or hyphae.  
       [0007] A fluid sample is also treated with saline solution and microscopically examined for the possible presence of clue cells (epithelial cells obscured by an overgrowth of bacterial cells), white blood cells and, among other things, motile organisms, spores and trichomonads.  
       [0008] The combination of pH determination plus the KOH and saline microscopic examination is the most widely accepted and clinically used method in determining the cause of vaginitis.  
       [0009] At the present time, there is a lack of inexpensive, convenient techniques for supporting performance of the diagnostic steps. The use of the pH stick, and the need to dispose of after use has been mentioned. Performance of the wet mount tests complicates the matter since handling of fluid and reagents of samples for microscopic examination can be cumbersome. It can involve, for example, tearing off a piece of pH paper from a roll and wetting it with a vaginal sample. It may also involve the use of a separate container or vial, for transporting the sample to a laboratory either in an office or at a clinic for microscopic examination. Drops of the sample are then placed on two sites of a microscope slide. In some cases, a wax line is drawn down the center of a diagnostic device in an attempt to keep the saline treated fluid separate from the KOH treated fluid during the microscopic examination. At other times, two separate microscope slides are used to avoid mixing the two solutions. After microscopic examination, of course, the waste management problem is presented once again as disposal of wet slides, pH paper, pH sticks and transport containers or vials becomes necessary.  
       [0010] The above-mentioned conventional techniques are awkward to perform, time consuming and can present a problem in disposal of wet materials, possibly carrying pathogens. Accordingly, there has been a need for a diagnostic technique that provides a quick, relatively inexpensive and reliable way to perform the three tests on vaginal fluid samples in a more convenient, economical fashion. Desirably, such a technique would help ameliorate the waste disposal and handling problems. Many clinicians, therefore, skip one or more of these diagnostic steps and try to rely on guesswork to make a diagnosis here and this has been shown in studies to result in diagnostic and treatment errors.  
       DISCLOSURE OF THE INVENTION  
       [0011] In a preferred embodiment, the invention provides a diagnostic device and kit for use in performing clinical tests on a specimen fluid. The diagnostic kit includes light transmitting slides with or without attached slipcovers, tests solutions for facilitating microscopic analysis procedures, a differential diagnosis chart to provide an immediate visual indication of any microscopy including syndrome identifiers and diagnostic criteria, specimen obtaining sterile applicators, and test result cards. Each individual slide is a transparent plate covered by a panel overlay, which is sufficiently thick for defining a plurality of test site wells. Indicia indicators disposed on the panel overlay adjacent to each individual test site well, provides technical assistance in the performance of diagnostic analysis on fluid specimens deposited within the test site wells. Each test site well is sufficiently deep to confine the fluid specimen as well as a measured drop quantity of one or more of the test solutions. An individual one of the test site wells is a pH testing well that has disposed therein a strip of pH testing material, wherein the pH testing material produces a color indicative of fluid pH upon contact with a fluid specimen. The indica indicator disposed adjacent to the pH testing well is a pH chart to provide a comparison color chart for immediate identification of the fluid specimen pH level. Another one of the test site wells defines a light-passing window wherein the indicia disposed adjacent to the window is a procedure indicator for facilitating microscopic analysis of a fluid specimen deposited within the well.  
       [0012] A diagnostic device and kit embodying the invention is mechanically simple, and is easy and convenient to use. It enables the grouping of components in a relatively small, easily reached countertop area and helps improve safe waste management by reducing the number of contaminated implements requiring disposal.  
       [0013] Other aspects and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the invention. 
     
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
     [0014]FIG. 1 is an isometric view of a preferred embodiment of a diagnostic device that is constructed according to the present invention;  
     [0015]FIG. 2 is a plan view of the diagnostic device shown in FIG. 1;  
     [0016]FIG. 3 is an exploded pictorial view of another preferred embodiment of a diagnostic kit that is constructed in accordance to the present invention;  
     [0017]FIG. 4 is an isometric view of a kit container of FIG. 3;  
     [0018]FIG. 5 is an isometric view of another preferred embodiment of a diagnostic kit that is constructed in accordance to the present invention; and  
     [0019]FIG. 6 is an isometric view of still yet another preferred embodiment of a diagnostic kit that is constructed in accordance to the present invention. 
    
    
     BEST MODE FOR CARRYING OUT THE INVENTION  
     [0020] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.  
     [0021] In the following detailed description and in the several figures of the drawings, like elements are sometimes identified with like reference numerals.  
     [0022] As shown in the drawings for purposes of illustration, the invention is embodied in a novel diagnostic kit and device for enabling effective and efficient real time diagnosis of a medical condition. The diagnosis comprises both gross examination and microscopic examination of a bodily fluid by means of a device that is simple and convenient to use and, as one piece, is relatively safer from a waste management viewpoint.  
     [0023] Referring now to the drawings, and in particular to FIGS. 1 and 2, there is shown a diagnostic device  10  that is constructed according to the present invention. The diagnostic device  10  is a disposable device that enables a clinician to perform a series of tests on vaginal fluid samples in a more convenient, economical fashion as will be explained hereinafter in greater detail. Moreover, since the diagnostic device  10  is disposable it helps ameliorate waste disposal and handling problems associated with other testing devices.  
     [0024] Considering now the diagnostic device  10  in greater detail with reference to FIGS.  1 - 2 , the diagnostic device  10  is formed from a generally rectangular, light transmitting blank, or plate  12 . The plate  12  is generally about 2 inches in height and about 3 inches in width and thus, is very easily handled.  
     [0025] As best seen in FIG. 1, the plate  12  is substantially covered by a stiff paper or cardboard panel  14  that adheres to an upper surface  13  of the plate  12 . In the upper half of the panel  14  there is disposed a color gradient chart, generally referred to by the reference numeral  28 . The color gradient chart  28  provides a series of color indicators  24 , where colors across the gradient are indicative of pH indicators of about pH 3.0 to about pH 5.5. This color gradient arrangement, allows a clinician to conduct a simple visual matching, without the need of resorting to any other charts or tools for determining the pH level of a sampled fluid as will be explained hereinafter in greater detail.  
     [0026] A pair of adjacent cutouts or windows  31  and  41  respectively, is disposed in the panel  14  in its lower right quadrant. Another cutout or opening  18  is also disposed in a lower left quadrant of the panel  14 . A strip of pH testing material, here in the form of pH indicator paper  19 , is fixed between the plate  12  and the panel  14  to fill substantially the opening  18 . The panel  14  is sufficiently thick to form a step or a wall  22  circumscribing the opening  18 . The wall  22  in cooperation with plate  14  defines a test site well that helps confine any fluid placed in the opening  18 . As in the case of the opening  18 , steps or walls  35  and  45  circumscribe the windows  31  and  41 , respectively, that serve to retain fluids within the respective test site areas therein defined. In this manner, after examination is completed, effective elimination of possibly contaminated fluid can be accomplished.  
     [0027] To further help facilitate retaining any vaginal fluids deposited in the window area wells  31  and  41 , the diagnostic device  10  includes a pair of cover slips, such as the cover slips  58  and  59  respectively. The cover slips are adapted to be attached to the top surface of the panel  14  by a flexible adhesive hinge, such as the hinge  60 . In this manner, after a vaginal fluid sample has been deposited into either window area, the slip cover can be attached to the plate  14  as indicated allowing the cover to close the fluid receiving area of the window. In the preferred embodiment of the present invention, the slip covers  58  and  59  are separated from the panel  14 . It will be understood however, by those skilled in the art, that the slip covers could also be initially attached by their respective hinges, such as the hinge  60 , rather than be separated.  
     [0028] Considering now the method of using the diagnostic device  10  for testing vaginal fluids, the clinician in testing for fluid pH, first places a drop of fluid (not shown) onto the pH indicator paper  19  and observes any color change in the paper. The resultant color is indicative of the fluid pH and this can be determined readily by reference to the colored chart  28 . Thus, by simple visual matching, and without need to resort to other tools or separate reference color charts, the clinician can determine the pH of the fluid.  
     [0029] As set forth above, microscopic analysis is appropriate, along with a determination of fluid pH. Such analysis is facilitated by use of the windows  31  and  41  formed in the label  14 . As in the case of the opening  18 , steps or walls  35  and  45  circumscribe the windows, respectively, that serve to retain fluids within the respective areas therein defined.  
     [0030] In use of the diagnostic device  10 , microscopic examination of both the KOH and saline preparations are preferred. In this regard, upon determination of the type of microscopic examination desired, the clinician chooses the KOH window  31  and then after examination the saline window  41 . As best seen in FIG. 2, indicia  52 , located adjacent the window  41 , displays the word “Saline” to prompt the clinician to add this solution to fluid previously placed on the window  41 . In a similar manner, indicia  56 , located adjacent the window  31 , prompts the clinician to add potassium hydroxide (KOH) to the fluid on the window  31 . It should be understood by those skilled in the art that although the preferred embodiment of the present invention describes the test solutions as a saline solution and a potassium hydroxide solution, the diagnostic device  10  can be utilized to conduct gross and microscopic testing that may utilize other types of test solutions. There is therefore no intention to limiting the test solution described in the kit to only saline and potasium hydroxide.  
     [0031] After the suitable reagents have been added to the fluids in the windows  31  and  41 , cover slips  58  and  59 , respectively, cover the windows for the microscopic examination. One skilled in the art will recognize at this step of the diagnostic process that subsequent disposal of the diagnostic device  10  and its contents is simplified by having all the reactants compartmentalized on the single plate  10 .  
     [0032] Referring now to the drawings, and in particular to FIGS. 3 and 4, there is shown a diagnostic kit  210  that is constructed according to the present invention. The diagnostic kit  210  is disposable when it has been spent and accordingly the kit enables a clinician to perform a series of tests on fluid samples in a more convenient, economical fashion as will be explained hereinafter in greater detail. Moreover, since the diagnostic kit  210  is disposable it helps ameliorate waste disposal and handling problems associated with other testing kits and devices.  
     [0033] Considering now the diagnostic kit  210  in greater detail with reference to FIGS.  3 - 4 , the diagnostic kit  210  is a self contained and disposable when spent and includes the necessary elements to enable a physican to perform an in office diagnostic analysis in a quick, relatively inexpensive and reliable manner. In this regard, there is no necessity of sending specimen samples outside of the office and thus, testing and diagnostic analysis can be immediately performed while a patient is conveniently waiting in the office for test results.  
     [0034] The diagnostic kit  210  generally includes a primary storage box or container  212  that is adapted to secure the kit&#39;s operative elements in a sufficiently protected manner to allow a physican to carry the operative elements of the kit from examination room to examination room. The container  212  is formed from a single sheet of stiff cardboard that has been cut and folded to form a sturdy container that holds all the operative elements of the kit  210 . In this regard, the container  212  includes a base or floor  280  that is folded at its right side to form a right side panel  260  and folded at its left side to form a left side panel  262 .  
     [0035] The right side panel  260  is further folded along a fold line F to form a right inside wall  282  and a right tab-receiving pocket  261 . The inside wall  282  includes a tab (not shown) that is secured in a right side base slot (not shown) to hold the right side panel  260  and its integrally connected right inside wall  282  in an upright position.  
     [0036] In a similar manner the left side panel  262  is folded along another fold line F to form a left inside wall  284  and a left tab-receiving pocket  263 . The inside wall  284  include a tab (not shown) that is secured in a left side base slot (not shown) to hold the left side panel  262  and its integrally connected left inside wall  284  in an upright position.  
     [0037] The base  280  is further folded upward at its front side to form a front wall  264  that is further folded along a fold line A to form a platform or well panel  265 . The well panel  265  is folded downward along another fold line A to form a supporting member (not shown) with a set of tabs (not shown) that are secured in a pair of floor slots (not shown) to help establish a well space below the well panel  265 . The well panel  265  is cut at its right side to form a right side well panel tab  286  and cut at its left side to form a left side well panel tab  288 . The right tab  286  is received within a right side wall slot  268  that is formed in the right inside wall  282 . In a similar manner, the left tab  288  is received with a left sidewall slot  269  that is formed in the left inside wall  284 . In this manner the right and left sides of the well panel  265  are further supported to help establish the well space below the well panel  265 .  
     [0038] As best seen in FIG. 4, the front wall  264  is cut to form a right front wall tab  266  and a left front wall tab  267 . The tabs  266  and  267  are received within the right tab-receiving pocket  261  and the left tab-receiving pocket  263  to help secure the front wall  264  in an upright position.  
     [0039] The base  280  is further folded upward at its backside to form a back wall  290 , which includes and integrally attached lid  248 . The lid  248  is attached along a fold line B that permits the lid to pivot downward to help close a main compartment area  247  within the container  212 .  
     [0040] Considering now the lid  248  in greater detail with reference to FIG. 4, the lid  248  is folded along a fold line R at its right side to form a right side closure panel  256 ′ and folded along another fold line R at its left side to form a left side closure panel  258 ′. The right side closure panel  256 ′ and the left side closure panel are received within the rain compartment area  247  and press outwardly against the right side wall  282  and the left inside wall  284  to help hold the lid  248  in a closed position.  
     [0041] The lid  248  is further folded along a fold line T to form a closure panel  254 . The base  280  is cut about the closure panel  254  to form a right side closure tab  256  and a left side closure tab  258 . The tabs  256  and  258  are folded downward along respective fold lines W to permit the tabs  256  and  258  to be received within the right tab receiving pocket  261  and the left tab-receiving pocket  263  when the lid  248  is pivoted downward along the fold line B disposed at the top of the back wall  290 . In this regard, the tabs  256  and  258  are received within the tab receiving pockets  261  and  263  when the closure panel  254  is pivoted downward along fold line T. In this manner the lid  248  is releasably secured to tightly close and seal off the main compartment area  247 .  
     [0042] Considering now the main compartment area  247  in greater detail with reference to FIGS.  3 - 4 , the main compartment area includes an back compartment area or a sterile applicator package well  238 , that has a sufficient volume to contain a plurality  222  of sterile applicator packages, such as an applicator package  223 . Each applicator package, such as the applicator package  223  has disposed therein, as best seen in FIG. 3, a sterile applicator  225  that includes an elongated stick  228  having a cotton ball or swap  229  disposed on its distal end. The applicator package well  238  is bounded on its backside by the back wall  290 , and bounded on its right and left side by the right inside wall  282  and the left inside wall  284  respectively. The front side of the applicator package well  238  is bounded by the back supporting wall (not shown) of the well panel  265 .  
     [0043] Considering now the well panel  265  in greater detail with reference to FIGS.  3 - 4 , the well panel  265  has a plurality of cutouts that form a plurality of diagnostic tool wells. In this regard, there is a primary diagnostic tool well  232  for receiving therein a box  213  that contains a plurality  214  of diagnostic tool devices or slides, such as a diagnostic device  215 . The diagnostic device  215  will be described hereinafter in greater detail.  
     [0044] In order to help facilitating instructing a physician or clinician in using the kit  210 , instruction indicia  244  is provided on the well panel  265  immediately above the primary diagnostic tool well  232 . The well panel  265  also includes component identification indicia to help a user identify the various operative component disposed within the kit  210 . This includes primary diagnostic device indicia  294 , test solution identification indica  296  and  298  respectively, note indicia  246 , and cover slip indicia  299 . The exact indication of the component identification indica including the instruction indicia  244  will be described hereinafter in greater detail.  
     [0045] Considering the well panel  265  in still greater detail with reference to FIGS.  3 - 4 , the well panel  256  further includes a plurality of test solution wells  234  that are disposed adjacent to the test solution identification indicia  296  and  298  respectively. In this regard, a user can immediately identify the correct test solution to be utilized with the diagnostic procedures made possible by use of the kit  210 . In the preferred embodiment of the present invention, the kit  210  is a vaginal test kit that includes a bottle of saline solution  218  and a bottle of potassium hydroxide (KOH) for performing wet mount testing of vaginal fluid specimens obtained from a patient.  
     [0046] The well panel  265  further includes a cover slip well  236  which is disposed adjacent to the cover slip indicia  299 . The cover slip well  236  is dimensioned for holding therein a box (not shown) of cover slips or a plurality  216  of loose cover slips, such as a cover slip  217 . To help secure the cover slips  299  within the cover slip well  236 , a retainer slip  240  is attached to the well panel  265 . The retainer slip  240  is formed of a stiff piece of paper that is folded in such a manner as to provide a lid that extends over the cover slip well  236 .  
     [0047] Considering now the lid  248  in greater detail with reference to FIG. 34, the lid  248  includes an inside surface area  250  and an outside surface area  252 . The outside surface area  252  carries kit identification indicia (not shown) that identifies the type of diagnostic procedures or tests that can be performed with the kit, such as a vaginal test kit. The inside surface area  252  has attached thereto a stiff piece of cardboard  253  which is affixed at its bottom to the inside surface area to form a pocket area indicated generally at  255 . A hook and pile arrangement (not shown) permits the top of the cardboard  253  to be releasably secured to the inside surface area  252 . In this manner, an inside pocket  255  formed on the backside of the cardboard  253  can hold a plurality  257  of test result cards, such as an individual test result card  227  for easy retrieval when needed. The front side of the cardboard panel  253  has printed thereon a differential diagnosis chart  224 . The chart  224  provides the physican or clinician with quick reference to a differential diagnostic tool of diagnostic criteria, syndrome indications and microscopy indications that can be referred to as a specimen sample (not shown) is being examined.  
     [0048] Referring now to the drawings and more particularly to FIG. 5 thereof, there is illustrated another diagnostic test kit  412 , which is constructed in accordance to the present invention. In this preferred embodiment, the invention provides a diagnostic device and kit for use in performing clinical tests on a specimen fluid. The diagnostic kit  410  includes a box  413  for holding a light transmitting diagnostic device  10  (as best seen in FIGS.  1 - 2 ), tests solutions  434  for facilitating microscopic analysis procedures, a differential diagnosis chart  424  to provide an immediate visual indication of any microscopy including syndrome identifiers and diagnostic criteria, specimen obtaining sterile applicators  422 , and test result cards  427 .  
     [0049] The diagnostic device  10  is a transparent plate  12  covered by a stiff panel overlay  14 , which is sufficiently thick for defining a plurality of test site well locations  18 ,  31  and  41  respectively. Indicia indicators  28 ,  52 , and  56  respectively disposed on the panel overlay  14  adjacent to each individual test site well, provide technical assistance in the performance of diagnostic analysis on fluid specimens deposited within the test site well location.  
     [0050] The panel  12  is a thick piece of transparent material that readily passes light for microscopic examination purposes. In this regard, the panel  12  is sufficiently thick so that individual panel wells are provided within the panel  12  at each of the test site well locations  18 ,  31  and  41  respectively. The depth of each well location is determined by the depth of the associated panel well and the thickness of the panel overlay  14 . As the panel wells and the test site wells are disposed in the same relative area on the diagnostic device  10 , for simplicity in understanding the present invention, they are identified individually as well as in combination with one another as test site wells  18 ,  31 , and  41  respectively. Each test site well, such as test site well  31  is sufficiently deep to confine the fluid specimen as well as a measured drop quantity of one or more of the test solutions.  
     [0051] As best seen in FIGS.  1 - 2 , an individual one of the test site wells, such as test site well  18  is a pH testing well that has disposed therein a strip of pH testing material  19 , wherein the pH testing material produces a color indicative of fluid pH upon contact with a fluid specimen. The indica indicator  28  disposed adjacent to the pH testing well is a pH chart to provide a comparison color chart for immediate identification of the fluid specimen pH level.  
     [0052] Other ones of the test site wells, such as the test site wells  31 ,  41  define light-passing windows wherein the indicia indicated generally at  52  and  56  disposed adjacent to windows  41  and  31  respectively are procedure indicators for facilitating microscopic analysis of a fluid specimen deposited within the associated well locations.  
     [0053] Considering now the container  412  in greater detail with reference to FIG. 5, the container  412  includes a right side panel  460 , a left side panel  462 , and a front panel  464  that cooperate to define the primary storage area  447 . A right side wing-receiving pocket  461  is formed between the right side panel  460  and a fold down well panel  465  that is integrally connected at its front edge to the front panel  464 . In a similar manner a left side wing-receiving pocket  463  is formed between the left side panel  462  and the fold down well panel  465 .  
     [0054] To facilitate securing the fold down well panel  465  in a fixed position, the fold down well panel  465  includes a right well panel tab  466  and a left well panel tab  467 . The panel tabs  465  and  466  are adapted to be received within tab receiving slots  468  and  469  respectively.  
     [0055] Considering now the lid  448  in greater detail with reference to FIG. 5, the lid  448  includes an outside surface area  452  which carries kit identification indicia (not shown) that identifies the type of diagnostic procedures that can be performed with the kit, such as a vaginal test kit. The lid  448  has integrally attached thereto a set of foldable panels that include a closure panel  454 , a right side wing panel  456  and a left side wing panel  458 . The panels  454 ,  456 , and  458  are adapted to be received within the primary storage are  447  to secure the lid  448  in its closed position. More particularly, panels  456  and  458  are adapted to be received within the wing receiving pockets  461  and  463  respectively.  
     [0056] Considering the diagnostic device box  413  in greater detail with reference to FIG. 5, the diagnostic device box  413  is dimensioned to hold therein a plurality of the light-transmitting test slides, such as the test slides  215 , and includes a lid indicated generally at  470 , a right wing  472 , a left wing  473 , and a front flap  474 . The right wing  472 , the left wing  473  and the front flap  474  each fold downwardly from the lid  470  to be received within the slide box well space  432 . In this manner, the box  413  is secured within the well space  432  but the lid  470  may be opened to allow easy access to the light transmitting slides stored within the box  413  providing not only ease of access but also helps to secure the light transmitting slides within the box  413 .  
     [0057] Referring now to the drawings and more particularly to FIG. 6, thereof there is illustrated still yet another diagnostic test kit  510 , which is constructed in accordance to the present invention.  
     [0058] The diagnostic kit  510  generally includes a primary storage box or container  512  having a primary storage area  575  and a secondary or microscope storage area  580 . In this regard, the container  512  is a doublewide storage container that is able to hold all the operative elements of the kit. The preferred embodiment of this invention is similar to test kit  210  holding like operative elements (not shown for simplicity purposes) but which includes the doublewide box  512  having the main compartment  575  and a side compartment  580 .  
     [0059] Considering now the storage box  512  in greater detail with reference to FIG. 6, the side compartment  580  includes two wells, a test form well  582  and a microscope receiving well  584  which is dimensioned for receiving therein a microscope  586 . A lid  548  that is adapted to pivot about one of its edges for closing the primary storage area  575  as well as the microscope storage area compartment  580 .  
     [0060] The container  512  includes a plurality of diagnostic device or tool wells (or pockets) that includes 1) a slide box well  532  for securing a slide box  513  holding a plurality light-transmitting test slides (not shown) which individual light-transmitting slides are substantially identical to test slide  215 ; 2) a plurality of test kit solution wells, such as wells  534  for securing test kit solution containers (not shown), which containers are substantially identical to containers  218  and  220  respectively; 3) a cover slip well  536  and slipcover retainer  540  for securing a plurality of individual cover slips (not shown), which cover slips are substantially identical to cover slip  217 ; 4) a sterile applicator package well  538  for holding a plurality of sterile applicator packages (not shown), which individual packages are substantially identical to sterile applicator package and 5) a test result card pocket  526  for holding a plurality of individual 3×5 inch test result cards, such as a test result card  527 . The test result card pocket  526  is formed on the backside of a stiff piece of cardboard attached to an inside surface area  550  of the container top  548 . A differential diagnosis chart  524  is affixed to the outside face of cardboard to provide the physican with quick reference to a differential diagnosis tool of diagnostic criteria, syndrome indications and microscopy indications that can be referred to as a test sample (not shown) is being examined.  
     [0061] Considering now the container  512  in greater detail with reference to FIG. 6, the container  512  includes a right side panel  560 , a left side panel  562 , and a front panel  564  that cooperate to define the primary storage area  575  and the secondary storage area  580 . A right side wing-receiving pocket  561  is formed between the right side panel  560  and a fold down well panel  565  that is integrally connected at its front edge to the front panel  564 . In a similar manner a left side wing-receiving pocket  563  is formed between the left side panel  562  and the fold down well panel  565 .  
     [0062] In the preferred embodiment of the present invention, the side compartment  580  is shown extending t the right side of the main compartment  575 . However, those skilled in the art will understand that the side compartment  580  could be located in any other orientation relative to the primary compartment. That is, the secondary compartment can be located to left, in front of, or behind of the primary compartment through simple modifications to the overall container structure.  
     [0063] To facilitate securing the fold down well panel  565  in a fixed position, the fold down well panel  565  includes a right well panel tab  566  and a left well panel tab  567 . The panel tabs  565  and  566  are adapted to be received within tab receiving slots  568  and  569  respectively.  
     [0064] Considering now the lid  548  in greater detail with reference to FIG. 6, the lid  548  includes an outside surface area  552  which carries kit identification indicia (not shown) that identifies the type of diagnostic procedures that can be performed with the kit, such as a vaginal test kit. The lid  548  has integrally attached thereto a set of foldable panels that include a closure panel  554 , a right side wing panel  556  and a left side wing panel  558 . The panels  554 ,  556 , and  558  are adapted to secure the lid  548  in a closed position. More particularly, panels  556  and  558  are adapted to be received within the wing receiving pockets  561  and  563  respectively.  
     [0065] Considering the diagnostic device box  513  in greater detail with reference to FIGS.  3 - 4 , the diagnostic device box  213  is dimensioned to hold therein a plurality of the light-transmitting test slides, such as the test slide  215 . The diagnostic device box  513  includes a lid indicated generally at  570 , a right wing  572 , a left wing  573 , and a front flap  574  that each fold downwardly to be received within a slide box well space  532 . In this manner, the box  513  is secured within the well space  532  but the lid  570  may be opened to allow easy access to the light transmitting slides stored within the box  513 . In short then, the lid  570  can be opened and closed for helping to access and secure the light transmitting slides.  
     [0066] It will be evident that there are additional embodiments and applications that are not disclosed in the detailed description but which clearly fall within the scope of the present invention. The specification is, therefore, intended not to be limiting, and the scope of the invention is to be limited only by the following claims.