Abstract:
The present invention relates to a diagnostic kit and more specifically to a self contained diagnostic kit providing analysis of a sample by a sample collectin element and an immunochromatography test strip.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention generally relates to a diagnostic kit and more specifically to a self contained diagnostic kit providing analysis of a sample by a sample collecting element and an immunochromatography test strip. 
     2. Discussion of the Related Art 
     Flow test strips are most commonly used for the last thirty years. The test strips are used for the specific qualitative or semi-quantitative detection of many analytes including antigens, antibodies, and even the products of nucleic acid amplification tests. One or several analytes can be tested for simultaneously on the same strip. Urine, saliva, serum, plasma, or whole blood can be used as samples. Extracts of patient exudates or fluids have also been successfully used. 
     Test sensitivity can be quite good. For example, hepatitis B surface antigen (HBsAg) test strips have claimed a sensitivity of 1.0 ng HBsAg/ml or less. Test specificity can also be very high. The tests use colloidal gold, dye, or latex bead conjugates to generate signal. The assembled strips are dried and packaged, making them stable for months when properly protected from moisture and excessive heat. 
     To perform the test, a sample either used alone or with an extraction reagent or a running buffer is placed on the sample pad on one end of the strip. The signal reagent is solubilized and binds to the antigen or antibody in the sample and moves through the membrane by capillary action. If specific analyte is present, the signal reagent binds to it, and a second antibody or antigen-immobilized as a line in the nitrocellulose then captures the complex. If the test is positive, a pink/purple line develops. Once the specimen is added, the tests can be left unattended until they are read. The tests can be run individually or in limited-size batches. Results can usually be read in 5 to 15 minutes. All tests include an internal procedural control line that is used to validate the test result. Appearance of two lines, therefore, indicates a positive result, while a negative test produces only one line. 
     Diagnosis of certain conditions at the oral, genital and rectal cavities (i.e  Candida,  Bacterial Vaginosis, colon cancer, HPV) require a sample taken by a swab or other collecting applicators before testing for the analyte using test strips. Collecting a sample is followed by an action aimed to preserve the sample from being contaminated and to keep sample&#39;s qualities (e.g. stability and arrangement of all components). Preserving a sample can be secured by placing the sample in a sterile container, or alternatively, placing the sample within a preserving liquid. Preserving sample after collecting it is necessary because the diagnosis of analytes within sample is not done immediately after sample&#39;s collection. Moreover, analysis of samples using test strips is usually performed not on the site of sample collection. The next step is placing the sample on a sample pad on one end of the strip. Furthermore, analyzing a sample with a test strip often requires the placing of the sample within an extraction reagent or running buffer, which is placed on the sample pad. Placing a sample on a sample pad requires appropriate training. Consequently, sample collection is performed by personnel other than the personnel performing the analysis of the sample. Naturally, due to different causes (e.g. misplacement and swapping of samples, unsuitable conditions) the time and distance intervals jeopardize the accuracy of the diagnosis. Hence, there is a need for a diagnosis kit enabling accurate on-site analysis of the sample. 
     Recent prior art discloses a diagnostic kit having a diagnostic strip placed within a tubular container. The kit requires first the placing of a specimen on swab tip within the tubular container, and followed by placing a removable cap that contains a reagent. Then, adding the reagent for initiating an analysis of the specimen. The requirement to add reagent to the tubular container requires concentration and accuracy performed preferably by experienced laboratory staff for a successful diagnosis. Furthermore, adding the reagent will occur sometime after the collection of the sample and usually at remote location from the sample collecting location rather than immediately after collecting a sample. Thus the prior art does not disclose a self contained diagnostic kit due to the fact that additional action is required after the specimen is collected and inserted in tubular container. 
     Furthermore, there are ever increasing requirements of public health authorities worldwide aiming to provide simple and accurate test kits for self use by layman. For example, the U.S. Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. Thus, On Feb. 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly. 
     Therefore there is a need to provide a completely self contained diagnostic kit. Furthermore, there is a need to provide a diagnostic kit that does not require special training for initiating analysis after insertion of sample. There is a need to provide a simple constructed self contained diagnostic kit. The above advantages as well as other are included in various embodiments of the disclosed invention. 
     SUMMARY OF THE PRESENT INVENTION 
     The present invention relates to a self contained diagnostic kit for analysis of samples. The diagnostic kit provides that subsequent to inserting a sample to the diagnostic kit an analysis of the sample initiates. One aspect of the present invention discloses a diagnostic kit for self analysis of at least one sample. The kit comprises a housing and at least one analysis strip unit, the analysis strip unit is positioned within the housing, the strip unit comprises a receptacle with an opening enabling initiation of analysis of the sample, and a flow strip comprising a sampling wick at one end of the flow strip. The sampling wick is adjacent to the receptacle. The receptacle can comprise a reagent. The analysis strip unit is structured to initiate analysis subsequent to contact with the sample. The analysis result of the analysis strip unit is visible. The diagnostic kit further comprises a sampling unit comprising a sampling element adapted to collect the sample. The sampling unit is removable from the housing. The sampling unit is adapted to reentered to the housing. The sampling unit is adapted to be received by the analysis strip unit. The sampling element is adapted to be received by the receptacle. The sampling element comprises a swab. The swab comprises at least one of the following materials, nylon, rayon, Dacron, cotton or any other materials. The sampling unit comprises a first end comprising the sampling element and a second end comprising a rod. The sampling unit comprises a rod wherein the rod comprises a first end adjacent to sampling element, and a second end having a plug. The plug substantially separates the analysis strip unit within the housing. The diagnostic kit can comprise one or more separators. The separator is adapted to aid defining at least two zones within the housing. The zone can comprise part of the analysis strip unit. One or more zones are adapted to enable removing the sampling unit out from the zone and to limit reentering the sampling unit to the zone. The sampling wick is adjacent to the opening of the receptacle. The sampling wick is adapted to be inserted to receptacle subsequent to the insertion of the sampling element to the receptacle. The analysis strip unit within the diagnosis kit is adapted to initiate analysis of the sample subsequently to the insertion of the sampling wick in the receptacle. The receptacle comprises a buffer, an extraction fluid, a combination thereof and the like. The receptacle is adapted to receive the sample. The opening of the receptacle is covered with a foil, which can be made penetrable. 
     According to a further aspect of the invention a diagnostic kit for self analysis of at least one sample is disclosed, the kit comprising a housing, a sample unit comprising a sampling element for collecting a sample and entering the sample to the housing, and an analysis strip unit, the analysis strip unit is positioned within the housing, the strip unit comprises a receptacle with an opening enabling initiation of analysis of the sample, and a flow strip comprising a sampling wick at one end of the flow strip, wherein the sampling wick is adjacent to the receptacle. The diagnostic kit further comprising at least one separator. The separator is adapted to aid defining two or more zones within the housing. The first zone comprises at least part of the analysis strip unit, and at least one second zone comprising a sample unit. The second zone is adapted to enable removing of sample unit from the second zone and limiting reentering of the sample unit to the second zone. The sampling wick is adjacent to the opening of the receptacle. The sampling wick is adapted to be inserted partially within the receptacle subsequent to the insertion of the sampling element within the receptacle. The analysis strip unit is adapted to initiate analysis of the sample subsequently to the insertion of at least a part of the sampling wick with the receptacle. The sampling element can be a swab. The receptacle comprises at least one reagent for extracting the sample from the sampling element. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: 
         FIGS. 1A ,  1 B are front and side views, respectively, of a diagnostic kit according to the present invention wherein an analysis strip unit and sampling unit are initially inserted within housing; 
         FIGS. 2A ,  2 B are front and side views, respectively, of a diagnostic kit according to the embodiment of  FIG. 1A  wherein the sampling unit is removed from the housing; 
         FIGS. 3A ,  3 B are front and side views, respectively, of a diagnostic kit according to the embodiment of  FIG. 1A  wherein the sampling unit is reentered the housing with sample; 
         FIGS. 4A ,  4 B are perspective close up views of sampling element before and after inserting receptacle element, respectively, without showing the separators, according to the embodiment of  FIG. 1A ; 
         FIG. 5  is a perspective view of sampling unit placed within a receptacle. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     The present invention provides a self contained diagnostic kit. The diagnostic kit comprises of a housing, and an analysis strip unit comprising a buffer reservoir that is positioned within the housing. The analysis of the sample can be initiated subsequently to the insertion of the sample to the housing. According to one exemplary embodiment the diagnostic kit comprises further a sampling unit having a sampling element such as a swab for collecting a sample and inserting the sample to the housing. Thus, subsequent to inserting the swab to the housing the analysis is initiated without further requirement of additional reagents or buffer. 
     According to another exemplary embodiment the diagnostic kit comprises further a sample receptacle that subsequent to the contact with the sample initiates its analysis. An embodiment of the invention is described below. 
       FIGS. 1A ,  1 B show a diagnostic kit  10  comprising a housing  12  with an analysis strip unit  20  and sampling unit  11 , both positioned within said housing. Housing  12  is a tubular shape and comprises a first open end  17 , used for insertion of samples in the housing, and second closed end  19 , used for placing analysis strip unit  20 . Housing  12  is made from transparent glass but can be made from any substantially inert and chemical resistant materials that are durable for the reagents used within an analysis. Thus, housing can be fabricated from different polymers e.g. polystyrene, polycarbonate, ceramic materials, a combination thereof and the like. The housing can be fabricated from transparent materials or opaque materials as far as part of the analysis strip unit  20  (i.e. lateral flow strip membrane  22  presenting the analysis results is depicted below) can be viewed on the outside of housing  12 . Analysis strip unit  20  is held in its position within housing  12  by placing end  25  of strip unit  20  in base  13 . Base  13  can be a stiff plastic structure adapted to end  19  of housing  12  which is rounded. Base  13  comprises a depression  21  adapted to end  25  of analysis strip unit  20 . According to other embodiments no base is required and an analysis strip unit can be positioned within a housing of a diagnostic kit without a supporting base. Analysis strip unit  20  comprises a flow testing strip comprising of a receptacle element  24  for receiving samples to be analyzed, a sample wick  28  with a conjugate pad  30  for initiating the analyzed conjugated liquid, lateral flow strip membrane  22  for visually presenting the analysis results, and lateral flow absorbent wick  32  for directing and aiding the capillary action advancement of the analyzed liquid from sample wick  28 . Receptacle element  24  is a receptacle cup shape liquid container fabricated from inert plastic or the like. Receptacle  24  comprises fluid solution  52  that is a reagent. Fluid solution  52  can be a buffer and/or an extraction liquid used for a sample inserted in receptacle  24 . Thus, insertion of a sample to fluid solution  52  enables (as depicted below) the analysis initiating soon after sample wick  28  is dipped in fluid solution  52 . Receptacle  24  is initially sealed with foil  26  that seals the receptacle and its liquid contents  52 . Foil  26  can be fabricated from nylon or aluminum or any other material that substantially seals contents of receptacle  24 . Furthermore, according to the present embodiment, foil  26  is a material that can be penetrated by sampling unit  11  as shown in  FIGS. 4A ,  4 B. Receptacle  24  placed in base  13  is positioned on one end of analysis strip unit  20  and is adjacent to sample wick  28 . Receptacle  24  further comprises opening  67  covered with foil  26 . As shown in  FIG. 4A  sample wick  28  is juxtaposed to conjugate pad  30  at portion  51 . Portion  50  of sample wick  28  is initially (i.e. prior to the initiation of the diagnosis) placed above foil  26  of receptacle  24 . Conjugate pad  30  is attached to sample wick  28  and to flow membrane  22 . Lateral flow membrane  22  provides chromatographic presentation of analytes due to the analysis of the fluid advancing in capillary action within membrane  22 . The advancement of fluid from sample wick  28  and conjugate pad  30  through membrane  22  is enabled by flow absorbent wick  32  located in second end of strip unit  20 . 
     Sampling unit  11  comprises sampling element  36  and elongated rod  38 . Rod  38  is positioned adjacent to sampling element  36 . Sampling element  38  is able to collect a sample by contacting a substance. Collecting of sample can be by absorbing a sample from a substance with a sampling unit  38 . Sampling element  38  may be a sponge like swab, fibrous swab and the like. Sampling element  38  may be made of nylon, rayon, Dacron, cotton, a combination thereof and the like. Other embodiments can comprise other sampling units for collecting samples such as receptacle. Rod  38  is a flexible member used as an elongated handle for removing and inserting sampling unit  11  in housing  12 . Rod  38  can be made of a plastic material and the like. Sampling unit  11  comprises further a plug  40  at its proximal end. Plug  40  can be fabricated from synthetic rubber and the like. Plug  40  encircles rod  38  and is fitted to the perimeter of open end  17  of housing  12 . Thus, plug  40  substantially seals housing  12  when sampling unit  11  is fully inserted in the housing in both locations shown separately in  FIGS. 1A ,  3 A. The sealing by plug  40  prevents external contamination of an inserted sample, sampling unit  11 , or analysis strip unit  20 . Alternatively, in other embodiments a plug can separate a housing section from the rest of housing. Thus, a section of housing comprising a sampling unit within diagnostic kit can separate a housing to two or more sections by a plug from its surroundings thus, preventing external contamination of a sample, sampling unit, and analysis strip unit. 
     Diagnostic kit  10  provides a complete self contained kit.  FIGS. 1A ,  1 B show the initial state of diagnostic kit  10 .  FIGS. 1A ,  1 B show analysis strip unit  20  positioned within housing  12 . Additionally, diagnostic kit  10  is supplied with sampling unit  11 . Plug  40  ensures the substantial sealing of housing  12 . Thus, the initial state of diagnostic kit  10  provides a kit with all elements required to perform an analysis of a sample.  FIGS. 2A ,  2 B show diagnostic  10  after sampling unit  11  is removed from housing  12 . Sampling unit  11  is removed from housing  12  in order to collect a sample (not shown). Thus, analysis strip unit  20  remains within housing  12  ready to receive a sample and initiate its analysis.  FIGS. 3A ,  3 B show sampling unit  11  re-entered housing  12  and placed in receptacle  24 . As more clearly shown in  FIGS. 4A ,  4 B sampling unit  11  upon re-entering housing  12  penetrates foil  26  and immerses the sampling unit approaching receptacle  24  is indicated by arrow  69 . Concurrently with penetrating foil  26  sampling unit  11  drags and dips sample wick  28  in fluid solution  52 . Consequently, placing sampling element  36  with action required. Analysis results are shown on membrane  22  shown in  FIG. 3B  with line  46  and control line  44 . 
     Diagnostic kit  10  comprises further two opposite separators, first separator  16  and second separator  18 . Separators  16 ,  18  are both flat elongated members with a bent proximal end. Separators  16 ,  18  have a width that is smaller than the width of housing  12 . Separators  16 ,  18  aid defining opposite zones,  15 ,  17 , respectively within housing  12 . Separators  16 ,  18  are fabricated from inert and stiff materials with limited flexibility such as high density plastic materials and the like. Separator  16  defines zone  15  for initially placing sampling unit  11  (i.e. prior to the initiation of the diagnosis) as shown  FIGS. 1A ,  1 B. Separator  16  is attached at one end to receptacle  24  thus affixing its position within housing  12 . The proximal end of separator  16  comprises a bent section  14  leaving gap  13  between separator  16  and adjacent wall of housing  12 . The width of sampling element  36  is wider than gap  13 . Thus, once sampling unit  11  is removed from zone  15  as shown within  FIGS. 2A ,  2 B it will not be returned to the zone  15  due to the width of gap  13 . Separator  18 , substantially placed opposite to separator  16  within housing  12 , is attached at one end to receptacle  24  affixing its position within the housing. Attachment of separators  16 ,  18  to receptacle  24  can be by using durable glue, a clip, and the like or by welding. Separator  18  comprises a proximal bended end  34  having its tip placed adjacent to wall of housing  12 . Thus, separator  18  defines zone  17  within housing  12 . According to the present embodiment, analysis strip unit  20  with the exception of receptacle  24  and part of sample wick  28  (i.e. portion  50  of wick  28 ) is positioned within zone  17 . As shown best in  FIGS. 2A ,  2 B, the structure and position of separators  16 ,  18  create passage  21 . Passage  21  dictates the route of sampling unit  11  reentering housing  12  after collecting a sample (i.e. sampling element  36  comprising sample  60  for analysis). Accordingly,  FIGS. 3A ,  3 B demonstrate sampling unit  11  reentered housing  12 . Passage  21  verifies that sampling element  36  with sample  60  will reach receptacle  24  and fluid solution  52 . Furthermore, as depicted above, insertion of sampling unit  11  for analysis verifies substantial sealing of housing  12  by plug  40  and avoiding possible contamination within housing  12 . 
       FIGS. 2A ,  2 B show housing  12  with analysis strip unit  20  after removing sampling unit  11  from diagnostic kit  10 . Gap  13  does not provide reentering of sampling unit  11  and sampling element  36  into zone  15 . Thus, sampling and using the diagnostic kit  10  comprises the following steps: removing sampling unit  11  from housing  12  from its initial position shown in  FIGS. 1A ,  1 B. Sampling unit collects sample from a surface (e.g. vaginal surface, food remains on a table) not shown. Sampling unit  11  reenters housing  12  and navigated to receptacle  24 . Accordingly, swab  36  drags sample wick  28  into receptacle  24  concurrently penetrating foil  26  and tearing it open. Thus, sample within swab  36  is immersed within fluid solution  52  and sample wick  28  is dipped within fluid solution  52 . Consequently, analysis of sample  60  is initiated. 
     The present invention provides that a diagnostic kit can be provided with a sampling unit to a user. The diagnostic kit comprises an analysis strip unit and all reagents and buffer solution for performing an analysis. The sampling unit can be removed from the diagnostic kit for collecting a sample and after returning the sampling unit with a sample to the diagnostic kit for performing an analysis. A sample can be collected from any surface or location. Subsequent to collecting the sample the sample is inserted to the diagnostic kit and sample is immersed with a reagent or buffer solution within the diagnostic kit positioned adjacent to the analysis strip unit and a sample wick as disclosed above. Consequently, after immersing the sample and after the sample is dipped in the solution the analysis is initiated, thus using an analysis strip capillary forces force the transfer of substance analyzed along the strip. 
       FIG. 5  provides a further perspective view of sampling unit  11  and sampling element  36  inserted in receptacle  24 . Sampling element  36  is shown with sample  60  after penetrating foil  26  and having pushed down portion  50  of sample wick  28 . Thus, one end of portion  50  is dipped within fluid solution  52 . Subsequently, to the insertion of sampling element  36  with sample  60  within fluid solution  52 , sample  60  is immersed and/or reacts with reagent comprising fluid solution  52  forming a sample for analysis (not shown) within the solution  52  by analysis strip  20 . Consequently, after portion  50  absorbs said sample for analysis from solution  52  analysis is begun. 
     The next examples provide some exemplary embodiments of the present invention as follows: 
     EXAMPLE 1 
     Preparation of Immunochromatography Lateral Flow Strip for Diagnosis of  Candida    
     Immunochromatography strip was prepared by assembly of different membranes, sequentially arranged on a non-absorbing clear plastic film with a release liner protected adhesive, serving as back laminate (ARcare 8876, Adhesive Research, Limerick, Ireland). The layers comprises a first sample pad (cellulose paper 2992 S&amp;S), a second conjugate pad (Glass fiber filters Millipore, GFCP0010000) pre impregnated with gold conjugates, a chromatography membrane made of Nitrocellulose (Nitrocellulose HF18004, Millipore) and an absorbent pad (Gel blotting paper, S&amp;S, GB003). The sample pad, conjugate pad and nitrocellulose are layered to form an overlapping there between, preferably of about 1 to 2 mm length. 
     A detection capture line is formed on top of the nitrocellulose membrane by plotting a solution of 1 mg/ml of Rabbit anti  Candida  polyclonal antibodies in 10 mM phosphate buffer pH 7. 
     The conjugate pad is made by soaking a glass fiber filter in a solution of colloidal gold conjugated to the same polyclonal antibodies anti- Candida  that are used for the capture line. The conjugate coating solution comprise on 5% Trehalose in 50 mM Tris buffer. Following the soaking of the conjugate solution, the pad is dried overnight at 37° C., before assembly of the strip. The assembled card is cut into 4 mm strips. 
     EXAMPLE 2 
     Running of Test Strips with  Candida  Samples 
     The strips constructed as described in example 1 above, were tested for the presence of  Candida  antigens in cultures of different  Candida  species. Sample solutions were made by mixing 10 μl of culture with 50 μl running buffer composed of 0.5% PEG (PolyEthyleneGlycol-15000, Merck, 819003), 0.5% BSA (01200050, Seracare, Calif., USA), 0.1% Tween 20 (Sigma, P-5927), 0.1% MgCl2 (Merck 1200310) in TBS (Tris buffer saline) pH 7.8. 
     To start the test, 60 □l of sample solution was loaded onto the sample pad of the strip and. A Positive result appeared as a red line at the capture line within 1-15 min. Negative control (where no  Candida  present) didn&#39;t show any red line. The strips were observed up to 30 minutes. 
     The intensity of the signal was assigned “+” values (see Table 1) alternatively or in addition, the color can be detected and measured by an electro-optical instrument. The signal appearance time from the loading of the sample to the test strip and the intensity of the signal at 15 minutes are shown in the table. The results are summarized in following Table 1. 
     
       
         
               
             
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 results obtained by the Candida test strip 
               
             
          
           
               
                   
                 Culture (10 μl) + 
                 Signal intensity 
               
               
                   
                 50 μl buffer 
                 after 15 minutes* 
               
               
                   
               
               
                   
                   C. albicans  10 6  cells/ml 
                 ++++ 
               
               
                   
                   C. albicans  10 5  cells/ml 
                 +++ 
               
               
                   
                   C. albicans  10 4  cells/ml 
                 ++ 
               
               
                   
                   C. albicans  10 3  cells/ml 
                 + 
               
               
                   
                   C. glabrata  10 4  cells/ml 
                 +++ 
               
               
                   
                   C. krusei  10 4  cells/ml 
                 ++++ 
               
               
                   
                   C. tropicalis  10 4  cells/ml 
                 ++++ 
               
               
                   
                   L. plantarum  5 × 10 6  cells 
                 − 
               
               
                   
                 Buffer 
                 − 
               
               
                   
               
               
                 *Relative signal intensity: Very strong (++++), strong (+++), medium (++), weak (+) and no signal (−). 
               
             
          
         
       
     
     EXAMPLE 3 
     Testing Clinical Samples in  Candida  Lateral Flow Strips 
     152 clinical samples were tested to evaluate the clinical relevance of the  Candida  test strip for the diagnosis of Vulvovaginal Candidiasis (VVC). Vaginal discharge samples were obtained from volunteers at the Genitourinary Infections unit of the Wolfson Medical Center, Holon, Israel. Vaginal discharges were collected by a physician using a sterile Nylon swab (552C, Copan, Italia). The swab heads (tips) were placed in 2 ml screw-cap tubes and kept at 4° C. until use. The vaginal swabs were washed by adding 300 μl of running buffer into the tube and by vortexing for 1 minute to elute the secretions from the swab and to achieve a homogenous sample. For each vaginal swab a diagnosis for  Candida  was done using wet mount microscopy and by culturing on Chromagar  Candida  Petri dish (HyLabs, Israel) for 48 h. From the 300 μl swab wash, 60 μl were taken for the test. The test was done as described above for culture samples. 
     Table 2 summarizes the result of 152 vaginal swabs washes that were diagnosed for VVC and tested with the  Candida  test strip. 
                                                                               TABLE 2                   Vaginal samples (N = 152) diagnosed for  Candida  with culture and       tested in the  Candida  lateral flow test.                  Candida  culture                        N = 152   Positive   Negative                          Candida     Positive   54   3           Lateral flow   Negative   6   89           test   Total   60   92                    
The Sensitivity of the  Candida  Test Strip is 90% and Specificity 96%.
 
     EXAMPLE 4 
     Preparation of Self Contained Diagnostic Swab for the Detection of  Candida    
     A prototype of the self contained device was prepared by using a commercially available nylon swab in a transparent collection tube (Copan, Italia). The collection tube of the swab was used as the housing of the swab and detection system. A buffer reservoir was made of a 200 μl PCR tube, filled with 100 μl of the aforementioned running buffer. The filled tube was sealed with a 1 cm 2  saran. A  Candida  test strip, prepared as aforementioned, was attached to the edge of the tube, in a way that the sample pad was laid on top of the sealing saran (see  FIG. 4   b ). The swab was removed from the collection tube and the buffer reservoir with the attached strip were inserted into the swab&#39;s collection tube, together with the swab. 
     EXAMPLE 5 
     Test of  Candida  Culture with the Self Contained Diagnostic Swab 
     The self contained diagnostic swab was tested culture of  Candida albicans.  The swab was pulled out of the tube, without taking out the buffer reservoir and strip, and was deep into a culture of  Candida albicans  for 10 sec. The swab was placed back into the collection tube and was pushed all the way into the buffer reservoir, through the sealing saran. Upon puncturing the seal, the buffer washed the swab tip, and fluid was contacted the sample pad and run into the strip. A Positive result appeared as a red line at the capture line within 1-15 min. Negative control (where no  Candida  present) didn&#39;t show any red line. The strips were observed up to 30 minutes. 
     The intensity of the signal at 15 minutes was assigned “+” values (see Table 2). 
     
       
         
               
             
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 results obtained by the self contained diagnostic swab for 
               
               
                 detection of  Candida   
               
             
          
           
               
                   
                   
                 Signal intensity 
               
               
                   
                 Culture 
                 after 15 minutes 
               
               
                   
               
               
                   
                   C. albicans  10 6  cells/ml 
                 ++++ 
               
               
                   
                 Negative culture 
                 − 
               
               
                   
               
             
          
         
       
     
     According to other embodiments a receptacle at an end of analysis test strip is held tightly against an elastic body by a sampling unit tip placed adjacent to the receptacle positioned on the closed end of a housing. The elastic body is adjacent on the opposite side to the housing wall. Accordingly, after the sampling unit is removed from the housing the receptacle is moved away from the elastic body into the centre of the closed end of the housing. Thus, removal of sampling unit from housing dictates that upon re-entering of the sampling unit tip it will be placed within the receptacle sealed with a foil. Thus, similarly to the embodiment above the sampling unit penetrates the foil and dips a sample pad within the receptacle. Other embodiments can provide other sealing means to a receptacle as well as to the housing. Further embodiments can provide a self contained kit including separators that are not flat and are partly rounded and support a receptacle for inserting a sample. Further embodiments may not include opposite separators or separators at all. In still further exemplary embodiments may not include a sampling unit. Thus, a sample may be entered to a receptacle and the analysis can be initiated by the contact of the sample with a buffer reservoir positioned within a housing. In other exemplary embodiments initiation of analysis of a sample is done by vibrations of the housing. The vibrations causing a sample wick to contact the receptacle and commence the analysis. Other embodiment can provide that the analysis can be read by an optical reader connected to a microprocessor which shows the results on a display unit outside the housing of a diagnostic kit. 
     The person skilled in the art will appreciate that what has been shown is not limited to the description above. The person skilled in the art will appreciate that examples shown here above are in no way limiting and are shown to better and adequately describe the present invention. Those skilled in the art to which this invention pertains will appreciate the many modifications and other embodiments of the invention. Some other embodiments of the present invention provide use of other sizes of strips, and other shapes of strips. Further embodiments provide the use of more than one strip unit. Other embodiments can provide the use of optical microprocessor for presenting the results. It will be apparent that the present invention is not limited to the specific embodiments disclosed and those modifications and other embodiments are intended to be included within the scope of the invention. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. Persons skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims, which follow.