Abstract:
A body fluid testing apparatus with testing and storing functions is provided, which comprises a body, a cover, at least two body fluid collectors and a testing element. The body comprises a fluid storing chamber, a testing chamber and a partition wall. The fluid storing chamber and the testing chamber are divided by the partition wall. The body is covered by the cover with at least two through-holes through which the body fluid collectors respectively enter into the fluid storing chamber and the testing chamber. The testing element is inserted into the testing chamber. Pollution is avoided, which results from that the body fluid in the testing chamber cannot flow back into the fluid storing chamber.

Description:
This is the U.S. national stage of application No. PCT/CN2010/001814, filed on 12 Nov. 2010. 
     TECHNICAL FIELD 
     The present disclosure generally relates to a medical apparatus, and particularly to a body fluid testing apparatus with testing and storing functions. 
     BACKGROUND ART 
     Body fluid testing apparatus currently have been commercially available, and have been reported in several patent documents. Such apparatuses can be used to test for drugs, glucose and parasite mixtures, and alternatives for antigen and antibody in body fluid. 
     U.S. Pat. No. 7,270,959 discloses a specimen collection container mainly for testing of urine, which comprises: a chamber for collecting a specimen; a reservoir; and a valve interposed between the chamber and the reservoir. The valve body of the valve has a compartment for transporting a portion of specimen from the chamber to the reservoir. Such specimen collection container is merely suitable for testing urine samples, but is not suitable for testing body fluid samples such as saliva with a small amount of collection. 
     U.S. Pat. No. 7,507,373 discloses an assay device mainly for testing urine, which comprises: a transparent container for retaining a liquid sample to be tested; a testing member in said container; and test strips in said testing member. 
     Chinese Patent Application No. 201251578 discloses an apparatus for body fluid collections and tests. All the apparatuses as described above are merely suitable for the preliminary screening of body fluid samples, but have no storing function for the samples required to be screened twice or more times. 
     Thus, there is a demand for a simple apparatus for body fluid tests, to overcome the problem that the conventional apparatuses for body fluid tests can not implement both the preliminary screening and the secondary screening of the volatile body fluids such as saliva. 
     SUMMARY OF THE INVENTION 
     An object of the present disclosure is to provide a body fluid testing apparatus with testing and storing functions. The body fluid testing apparatus can carry out both the preliminary screening and the secondary screening, and can even be sent far away for secondary screening, while the samples to be tested can be still well preserved. 
     In one aspect, the present disclosure provides an body fluid testing apparatus with testing and storing functions, comprising: a body, a cover, at least two body fluid collectors and a testing element, wherein the body comprises a fluid storing chamber, a testing chamber and a partition wall, and the fluid storing chamber and the testing chamber are divided by the partition wall; the cover is disposed on and covers the body and is provided with at least two through-holes, and the at least two body fluid collectors capable of entering into the fluid storing chamber and the testing chamber through the at least two through-holes respectively; the testing element is capable of being inserted into the testing chamber and positioned against the inner wall of the testing chamber, and comprises a main part with several channels for containing test strips and an inserting end extending downward from two edges of the main part. 
     Preferably, the fluid storing chamber comprises a body fluid squeezing region, a body fluid flow channel and a body fluid reservoir, and the body fluid squeezing region is communicated with the body fluid reservoir though the body fluid flow channel. 
     Preferably, the body fluid reservoir partly surrounds the periphery of the body fluid squeezing region, and the body fluid squeezing region comprises a squeezing plate and a wall plate extending upward from the edge of the squeezing plate. 
     Preferably, the squeezing plate in the body fluid squeezing region is positioned higher than the bottom plate of the body fluid reservoir, or positioned at the same level as the bottom plate of the body fluid reservoir. 
     Preferably, the wall plate is provided with at least one opening as the body fluid flow channel, and a lower part of the body fluid collector capable of entering into the space defined by the wall plate and the squeezing plate to avoid a horizontal displacement during being squeezed. 
     Preferably, the fluid storing chamber further comprises a partition plate, a top opening of the body fluid squeezing region is located on the partition plate, and the body fluid reservoir is located below the partition plate, the body fluid squeezing region is defined by a squeezing plate and a wall plate extending upward from the edge of the squeezing plate, and the lower part of the body fluid collector enters into the space defined by the wall plate and the squeezing plate, to avoid a horizontal displacement during being squeezed. 
     Preferably, the squeezing plate is provided with at least one opening as the body fluid channel. 
     Preferably, the testing chamber comprises a body fluid squeezing region, a body fluid flow channel and a slot, the slot is used to contain the inserting end of the testing element, and the body fluid flow channel communicates the body fluid squeezing region with the slot. 
     Preferably, the body fluid squeezing region is defined by a squeezing plate and a wall plate extending upward from the edge of the squeezing plate, and a lower part of the body fluid collector enters into the space defined by the wall plate and the squeezing plate, to avoid a horizontal displacement during being squeezed. 
     Preferably, the body fluid flow channel is configured to be concaved from the surface of the squeezing plate and communicated with the slot, and the bottom of the slot is located at a position lower than that of the squeezing plate. 
     Preferably, the wall plate is provided with at least one opening as the body fluid flow channel, and the bottom of the slot is positioned at a same level as the squeezing plate. 
     Preferably, an opening is disposed at the side wall of the fluid storing chamber or the upper surface of the cover, which is sealed with a sealing plug provided on a covering plate of the fluid storing chamber. 
     Preferably, the body fluid collector comprises a handle, a sampling end and a connecting bar connecting the handle with the sampling end. 
     Preferably, a coupling member is disposed in each of the through-holes of the cover, and the handle is provided with an adapting member matching to the coupling member. 
     Preferably, the coupling member is screw thread or fastener. 
     Preferably, the sampling end is made from absorbent material. 
     Preferably, a press plate is further provided on the lower end of the connecting bar, and the sampling end is connected to the bottom of the press plate. 
     Preferably, the body fluid testing apparatus is a saliva testing apparatus. 
     Preferably, the front surface and the back surface of the body of the body fluid testing apparatus are parallel to each other. 
     The present disclosure may have the following beneficial effects: since the body fluid testing apparatus according to the present disclosure has both the testing chamber and the fluid storing chamber, it can implement accordingly both the preliminary screening and the secondary exact screening for the samples. Further, according to the present disclosure, the testing chamber and the fluid storing chamber are not communicated with each other, and thereby it can be assured that the samples to be tested are not polluted during the rescreening and not affected by the preliminary screening. 
     Since the fluid storing chamber of the apparatus according to the present disclosure has an opening which can be sealed, the samples can be taken out through the opening for being tested. 
     Additionally, in view of high volatility and small sampling amount of the body fluid samples, especially for saliva samples, the collector of the apparatus according to the present disclosure is disposed in the fluid storing chamber with being completely squeezed, such that it can prevent the body fluid samples stored in the fluid storing chamber being reabsorbed by the collector due to the incomplete squeezing of the collector. 
     In the condition that the amount of the body fluid sample in the fluid storing chamber is small during the secondary screening, diluent can be added into the fluid storing chamber through the opening which can be sealed, such that the coagulation of saliva in the collector and the storing chamber can be dissolved, allowing the secondary screening to be achieved. 
     Further, according to the present disclosure, a body fluid reservoir containing saliva is disposed on the bottom of the fluid storing chamber, such that the body fluid or saliva collected can be gathered in the reservoir, which facilitates the sampling of saliva by the examiner during the secondary screening. 
     Further, since the two surfaces opposing to each other of the body of the body fluid testing apparatus according to the present disclosure are flat surfaces, the body fluid testing apparatus can be copied with a duplicator, and information about the subjects can also be recorded on said two opposing surfaces. 
     The foregoing and other features and advantages of the disclosure will be apparent to those skilled in the art in view of the following detailed description, taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a perspective cross-sectional view of the body fluid testing apparatus according to the first embodiment of the present disclosure. 
         FIG. 2  illustrates a perspective exploded view of the body fluid testing apparatus according to the first embodiment of the present disclosure. 
         FIG. 3  illustrates a top view of the body fluid testing apparatus according to the first embodiment of the present disclosure. 
         FIG. 4  illustrates a perspective cross-sectional view of the body fluid testing apparatus according to the second embodiment of the present disclosure. 
         FIG. 5  illustrates a top view of the body fluid testing apparatus according to the second embodiment of the present disclosure. 
         FIG. 6  illustrates a perspective cross-sectional view of the body fluid testing apparatus according to the third embodiment of the present disclosure. 
         FIG. 7  illustrates a top view of the body fluid testing apparatus according to the third embodiment of the present disclosure. 
         FIG. 8  illustrates a schematic view showing a testing sleeve in the body fluid testing apparatus according to the third embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The First Embodiment 
     As shown in  FIGS. 1-3 , the body fluid testing apparatus  1  comprises a body  100 , a cover  200 , a body fluid collector  300  and a testing element  400 . The body  100  comprises a fluid storing chamber  110 , a testing chamber  120  and a partition wall  130  for dividing the fluid storing chamber  110  from testing chamber  120 . The cover  200  is disposed on and covers the body  100  and is provided with two through-holes  210  each having internal thread  240 . The body fluid collector  300  comprises a handle  310 , a sampling end  320 , and a connecting bar  330  connecting the handle  310  with the sampling end  320 . The handle  310  is provided with external thread  340  to engage with the internal thread  240 . The sampling end  320  is made of absorbent material such as sponge. A press plate can be provided at the lower end of the connecting bar  330 , and the sampling end  320  is connected to the bottom of the press plate, such that the press plate can assist to squeeze the sampling end. The testing elements  400  are disposed parallel to each other in the testing chamber  120 , and are closely attached to two inner walls of the testing chamber  120 . The testing element  400  comprises a main part  410  and an inserting end  420 . The main part  410  is provided with several channels  440  for containing the test strips. The inserting end  420  extends downward from two ends of the main part  410 . In this embodiment, the testing elements  400  are two pieces of testing cards. 
     The internal structure of the body  100  will be described in detail below. 
     The bottom of the fluid storing chamber  110  is defined by a body fluid squeezing region  111 , a body fluid flow channel  112  and a body fluid reservoir  113 . The body fluid reservoir  113  partly surrounds the periphery of the body fluid squeezing region  111 . The body fluid squeezing region  111  comprises a squeezing plate  1111  and a wall plate  1112  extending a certain distance upward from the edge of the squeezing plate  1111 . A part of the wall plate  1112  extends upward until reaching and connecting with the partition wall  130 . The body fluid reservoir  113  comprises a bottom plate  1131 , an inner wall  1132  and an outer wall  1133 . The squeezing plate  1111  of the body fluid squeezing region  111  is located at a position higher than that of the bottom plate  1131  of the body fluid reservoir  113 . The inner edge of the bottom plate  1131  extends upward to form the inner wall  1132  connected with the squeezing plate  1111 . The outer wall  1133  serves as the side wall of the fluid storing chamber  110  and the side wall of the body  100  as well. The wall plate  1112  of the body fluid squeezing region  111  is provided with two openings, which extend from the periphery of the wall plate  1112  to the squeezing plate  1111  and are communicated with the body fluid reservoir  113 , serving as the body fluid flow channel  112 . 
     The side wall of the fluid storing chamber  110  is provided with a through-hole  116 , and the fluid storing chamber  110  is further provided with a covering plate  117  having a sealing plug  1171 . The covering plate  117  is mounted on the side wall of the fluid storing chamber  110  via the sealing plug  1171  with the through-hole  116  being sealed by the sealing plug  1171 . 
     The bottom of the testing chamber  120  is defined by a body fluid squeezing region  121 , a body fluid flow channel  122  and a slot  123 . The body fluid squeezing region  121  comprises a squeezing plate  1211  and a wall plate  1212  extending a certain distance upward from the edge of the squeezing plate  1211 . A part of the wall plate  1212  extends upward until reaching and connecting with the partition wall  130 , and a part extends upward until reaching and connecting with the side wall of the testing chamber  120 . The slots  123  are provided on opposite sides of the wall plate  1212  to contain the inserting end  420  of the testing element  400 , such that the testing element  400  is able to be disposed in the testing chamber  120 . The body fluid flow channel  122  is configured to be concaved from the squeezing plate  1211  and communicated with the slot  123 , wherein the top opening of the body fluid flow channel is located on squeezing plate  1211  and both ends of the body fluid flow channel are communicated with two slots  123 . The bottom of the slot  123  is located at a position lower than that of the squeezing plate  1211 . 
     The use of the body fluid testing apparatus will be explained below. 
     When in use, the body fluid collector  300  in the fluid storing chamber  110  and the body fluid collector  300  in the testing chamber  120  are taken out, respectively, and then put into mouth in turn. After sponges at the sampling ends  320  of the body fluid collectors become saturated, the handle  310  of one of the body fluid collectors  300  is held and screwed into the fluid storing chamber  110 , such that the external thread  340  on the handle  310  is tightly engaged with the internal thread  240  on the fluid storing chamber  110 . Under the condition of being tightly screwed, the sampling end  320  is tightly pressed against the squeezing plate  1111  in the fluid storing chamber  110 , and the moving of the collector  300  is limited by the wall plate  1112  in the body fluid squeezing region  111  in right and left directions, such that the body fluid collector is sufficiently squeezed. Saliva in the body fluid squeezing region  111  flows into the body fluid reservoir  113  through the body fluid flow channel  112 , such that the storing of saliva in the fluid storing chamber  110  is achieved. Since the external thread  340  on the body fluid collector is tightly engaged with the internal thread  240  on the fluid storing chamber, the pollution of saliva in the fluid storing chamber is avoided. 
     Similarly, the other body fluid collector  300  is subsequently screwed into the testing chamber  120 , such that the sampling end  320  of the body fluid collector  300  is squeezed. The length from the top of the testing chamber  120  to squeezing plate  1211  is fit for disposing the squeezed body fluid collector  300 . Under the condition of being tightly screwed, the sampling end  320  is tightly pressed against squeezing plate  1211  of the body fluid squeezing region  121  in the testing chamber  120 , and the moving of the sampling end  320  is limited by the wall plate  1212  of the body fluid squeezing region  121  in right and left directions. Saliva in the body fluid squeezing region  121  flows downward into the slot  123  through the body fluid flow channel  122  and then runs upward along the test strip on the testing element  400  in the testing chamber  120 . A mark will appear on the test strip according to the analyte contained in the saliva. 
     When the sample to be tested is required for rescreening, the body fluid collector will be sent to the rescreening institution. Then, the sealing plug  1171  on the side wall of the fluid storing chamber  110  is pulled out, and the untested saliva sample in the fluid storing chamber  110  can be taken out for re-screening by the user with a pipette via the through-hole  116 , or the sample may be taken out with a pipette via the through-hole  210  after the body fluid collector is screwed off the fluid storing chamber  110 . 
     The Second Embodiment 
     The body fluid testing apparatus  2  as shown in  FIGS. 4-5  is different from that in the first embodiment as described below. 
     The fluid storing chamber  110  is further provided with a partition plate  114  horizontally positioned in the fluid storing chamber  110 , such that the fluid storing chamber  110  can be divided into two spaces in up and down directions; the partition plate  114  is provided with a body fluid squeezing region  111  and a body fluid flow channel  112 , wherein the top opening of the body fluid squeezing region  111  is located on the partition plate  114 , and a body fluid reservoir  113  is located in the fluid storing chamber  110  below the partition plate  114 ; a wall plate  1112  of the body fluid squeezing region  111  extends downward from an opening of the partition plate  114 , and a squeezing plate is disposed in the space defined by the wall plate  1112 . 
     As shown in  FIG. 5 , the squeezing plate  1111  in the body fluid squeezing region  111  is provided with two openings as the body fluid flow channel  112 . When the handle  310  is tightly screwed, the sampling end  320  is tightly pressed against the squeezing plate  1111  in the fluid storing chamber, and the moving of the sampling end  320  is limited by the wall plate  1112  of the body fluid squeezing region  1111  in right and left directions, such that the sampling end  320  is sufficiently squeezed. Saliva in the body fluid squeezing region  111  flows into the body fluid reservoir  113  below through the body fluid flow channel  112 . 
     In this embodiment, the fluid storing chamber  110  is divided into two spaces by the partition plate  114 , and body fluid flow channel  112  is blocked by the sampling end  320  of the body fluid collector  300 , and meanwhile, the sampling end  320  is unable to absorb body fluid in the body fluid reservoir  113  under the condition of being sufficiently squeezed, such that the body fluid reservoir  113  of the fluid storing chamber  110  is sealed. Since body fluid is not likely to contact with other elements in the fluid storing chamber due to swaying during the transport of the apparatus, the pollution of body fluid in the fluid storing chamber is avoided, and the loss of body fluid is also reduced. 
     The structure and the use of the testing chamber according to this embodiment are similar to those according to the first embodiment, and then will not be described herein in detail. 
     The Third Embodiment 
     The body fluid testing apparatus  3  as shown in  FIGS. 6-8 , is substantially the same as that in the first embodiment, except for the bottom of the chamber and the slot. 
     In the fluid storing chamber  110  according to the present embodiment, the bottom plate  1111  of the body fluid squeezing region  111  is positioned at the same level as the bottom plate  1131  of the body fluid reservoir  113 , i.e., at the same level as the lower side of the outer profile of the fluid storing chamber  110 . In the testing chamber  120 , the squeezing plate  1211  in the body fluid squeezing region  121  is positioned at the same level as the bottom of the slot  123 . Further, the wall plate  1212  is provided with two opposing openings, which extend from the periphery of the wall plate  1212  to the squeezing plate  1211  and are communicated with the slot  123  as the body fluid flow channel  122 . 
     Additionally, in this embodiment, the testing element  400  is a testing sleeve, as shown in  FIG. 8 , which further comprises a connecting plate  430 . As shown in  FIG. 7 , the slot  123  further comprises an outside slot  1231  surrounding the outer wall of the testing chamber  120 , and the lower end of the connecting plate  430  can be inserted into the outside slot  1231  of the slot  123 . 
     Modifications may be made to the body fluid testing apparatus according to the present disclosure by those skilled in the art. For example, in shown embodiments, the body fluid flow channel is in the shape of a line or a cross, but it is not limited hereby. According to the disclosure, the cover is coupled with the body fluid collector in the manner that the external thread on the handle is engaged with the internal thread on the through-hole. However, the disclosure is not intended to be limited hereby, and the cover may be coupled with the body fluid collector in a manner of a fastener which is mounted on the handle for sealedly combining the handle to the testing chamber or the fluid storing chamber. Moreover, the opening of the fluid storing chamber can be provided on the upper surface. In addition, although the present disclosure is illustrated by example of saliva collection, the body fluid testing apparatus can also be used to test other body fluid. 
     Since the body fluid testing apparatus according to the present disclosure has both the testing chamber and the fluid storing chamber, it can implement accordingly both the preliminary screening and the secondary exact screening for the samples. Further, according to the present disclosure, the testing chamber and the fluid storing chamber are not communicated with each other, and thereby it can be assured that the samples to be tested are not polluted during the rescreening and not affected by the preliminary screening. 
     Exemplary embodiments have been specifically shown and described as above. It will be appreciated by those skilled in the art that the disclosure is not limited to the disclosed embodiments; rather, all suitable modifications and equivalent which come within the spirit and scope of the appended claims are intended to fall within the scope of the disclosure.