Abstract:
A sample port system/device associated with a fluid collection device is provided and is configured to receive fluid-containing devices of varying diameters. A method of improving the work flow and safety involved in acquiring and/or testing fluid samples using such sample port system/device is also provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The entirety of U.S. Provisional Application Ser. No. 61/642,820, filed on May 4, 2012, is hereby expressly incorporated herein by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    None 
       1. FIELD OF THE INVENTION 
       [0003]    The present invention relates in general to sample ports and microfluidic devices and systems and methods for using the same. More particularly, the present invention relates to a system and method for introducing a fluid sample to a medical diagnostic analyzer or microfluidic device. 
       2. BACKGROUND OF THE INVENTION 
       [0004]    Fluid collection devices including, but not limited to, microfluidic devices and multi or single use medical diagnostic devices such as blood gas, hematology, and urinalysis testing devices/systems and the like, are useful in a variety of applications, including performance of chemical, clinical and environmental analyses of chemical or biological samples. Such devices are particularly well suited for analyses of minute quantities of samples, and can be produced at relatively low cost. Microfluidic devices typically include open ports for sample introduction, channels for transferring fluids, and can include chambers for storing reagents, pumps, valves, filters, etc. 
         [0005]    The typical method of introducing a fluid sample to a microfluidic device has been to dispense the sample from the original collection device, like a syringe, onto the open port on the microfluidic device. In some case, like with the use of a vacutainer, it is sometimes necessary to first remove a portion of the fluid to be tested from the vacutainer by pipette or syringe, followed by dispensing the sample to the open port on the microfluidic device. Regardless of the exact method used, there exists a clear risk of a biohazard or chemical hazard spill when samples have to be dispensed to an open port. In addition, in cases like the use of a vacutainer described above, the use of multiple consumables is often required, which adds to the exposure risk and adds to the amount of chemical or biological hazardous waste which has to be handled and disposed. Also, dispensing samples manually to a fluid collection device not only presents a risk of exposure, but also ties up the hands of the technician, keeping them from other important tasks such as patient care, entering demographics, or other documentation tasks. 
         [0006]    Thus, there is a clear need for an improved system or method or device useful in accomplishing the task of dispensing samples to a fluid collection device which minimizes risks of exposure and frees up time for the technician. 
       SUMMARY OF THE INVENTION 
       [0007]    In accordance with an embodiment of the present invention, a port device or system for sample introduction to a fluid collection device is provided comprising: 
         [0008]    a) a first section of a frusto-conical shape having a first end with an internal diameter A and a second end with an internal diameter B, wherein B is less than A; 
         [0009]    b) a second section having a first end with an internal diameter C, a second end with an internal diameter D, a longitudinal axis extending from the first end to the second end, and a substantially circular internal surface along the longitudinal axis, wherein C is less than B, D is greater than C, and wherein the first end of the second section is in fluid flow communication with the second end of the first section; 
         [0010]    c) a third section having a first end with an internal diameter E, a second end with an internal diameter F, a longitudinal axis extending from the first end to the second end, and a substantially circular internal surface along the longitudinal axis, wherein E is less than C, wherein F is greater than E, and wherein the first end of the third section is in fluid flow communication with the second end of the second section; 
         [0011]    d) a base section having a first end with a diameter G and a second end, wherein G is less than E, wherein the first end of the base section is in fluid flow communication with the second end of the third section. 
         [0012]    In accordance with an embodiment of the present invention, the first section of such port device or system is configured to accept and substantially seal the outer surface of a tip of a device having an outside diameter greater than B and less than A. 
         [0013]    In accordance with an embodiment of the present invention, the second section of such port device or system is configured to accept and substantially seal the outer surface of a hollow tube having an outside diameter greater than or equal to C and less than D. 
         [0014]    In accordance with an embodiment of the present invention, the third section of such port device or system is configured to accept and substantially seal the outer surface of a hollow tube having an outside diameter greater than or equal to E and less than C and less than F. 
         [0015]    In accordance with an embodiment of the present invention, a port device or system for sample introduction to a fluid collection device is provided comprising a wall which is circular along its length, constructed of an elastomeric material, and comprising a first end having a first end internal diameter and a second end having a second end internal diameter; the wall having an inner surface defining at least a first sealing point having a first sealing point internal diameter and a second sealing point having a second sealing point internal diameter, each spaced between the first and second ends; wherein the second sealing point is located between the first sealing point and the second end; the wall further having an intermediate internal diameter at a location intermediate to the first and second sealing points; wherein the first sealing point internal diameter is less than the first end internal diameter and is less than the intermediate internal diameter; and wherein the second sealing point internal diameter is less than the intermediate internal diameter and less than the first sealing point internal diameter and is less than the second end internal diameter. 
         [0016]    In accordance with an embodiment of the present invention, a process for dispensing a fluid is provided, utilizing such port device or system which is connected to a fluid collection device, and comprises inserting a fluid-containing device containing a fluid into the port device until substantially sealed; and transferring the fluid into the fluid collection device. The fluid collection device can be used in a medical setting, such as a point of care/near patient setting, a lab setting or the like. The fluid can be a liquid or a gas. 
         [0017]    In accordance with an embodiment of the present invention, such port device or system is in fluid flow communication with an open inlet port of a fluid collection device. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1A  is a cross-sectional view of a sample introduction port associated with a fluid collection device, which is shown by way of example as a microfluidic testing device. 
           [0019]      FIG. 1B  is a cross-sectional view of a sample introduction port associated with a fluid collection device, which is shown by way of example as a microfluidic testing device also depicting the insertion of the tip of a device into the port. 
           [0020]      FIG. 1C  is a cross-sectional view of a sample introduction port associated with a fluid collection device, which is shown by way of example as a microfluidic testing device also depicting the insertion of the tip of a syringe into the port with engagement of the syringe threads to tabs on the port. 
           [0021]      FIGS. 1D and 1E  are each cross-sectional views of a sample introduction port associated with a fluid collection device, which is shown by way of example as a microfluidic testing device also depicting the insertion of a hollow tube into the port. 
           [0022]      FIG. 2  is a cross-sectional view of a sample introduction port associated with a fluid collection device, which is shown by way of example as a microfluidic testing device. 
           [0023]      FIGS. 3A and 3B  are schematic illustrations depicting a sample acquisition system and apparatus for acquiring a sample of blood from a vein. 
           [0024]      FIG. 3C  is a schematic illustration depicting the insertion of the test tube/test tube luer adaptor from the sample acquisition system of  FIGS. 3A and 3B  into the sample introduction port of  FIG. 1A . 
           [0025]      FIG. 3D  is a schematic illustration depicting the insertion of the test tube/test tube luer adaptor from the sample acquisition system of  FIGS. 3A and 3B  into the sample introduction port of  FIG. 2 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction, the arrangement of the components, or the details or order of the process steps set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. 
         [0027]    Also, it is to be understood that the phraseology and terminology employed herein is for purposes of description and should not be regarded as limiting. 
         [0028]    The present invention relates to a sample introduction device/system, hereinafter referred to as a “port”, which can accommodate a variety of sample introduction devices, such as, but not limited to, hollow tubes of various sizes, syringes, test tube luer adaptors, etc. The port is useful for transferring a fluid sample to a fluid collection device which can include, but is not limited to, a multi or single use medical diagnostic device such as blood gas, hematology, or urinalysis system or a microfluidic testing device, as either a part of such fluid collection device, or as connected to an open port in such fluid collection device. The fluid collection device can be selected from the group consisting of a multi or single use blood gas testing device or a microfluidic testing device. The port can be fixedly or detachably secured to the fluid collection device at an angle sufficient to allow for the transfer of fluid to the fluid collection device, and can be perpendicular to the surface of the fluid collection device. In the case of a microfluidic device, the port can also be secured to the top surface or a side surface of the fluid collection device. For example, the port can be (1) welded to the fluid collection device, such as by ultrasonic welding, (2) mechanically connected to the fluid collection device, such as by using one or more thread, (3) bonded to the fluid collection device using an adhesive or a cohesive, and (4) combinations thereof. The fluid sample can be any biological and/or medical fluid that can be tested and/or sampled with the aid of the fluid collection device. For example, the fluid sample can be selected from the group consisting of saliva, sputum, blood, urine, cerebral-spinal fluid, pleural fluid, dialysate and combinations thereof. In one embodiment, the port can be used to transfer both blood (e.g., for measuring HbA1C) and urine (e.g., for measuring Albumin/creatinine) to the fluid collection device. 
         [0029]    The port can comprise, consist of, or consist essentially of at least one section or portion capable of receiving a fluid containing device, more preferably a first section, a second section, a third section, and a base section. 
         [0030]    The first section is preferably of a frusto-conical shape and comprises, consists of, or consists essentially of a first end with an internal diameter A and a second end with an internal diameter B, wherein B is less than A. Internal diameter A can be at least about 2 and less than or equal to about 6 mm, more preferably at least about 3 and less than or equal to about 5 mm. Internal diameter B can be at least about 2 and less than about 6 mm, more preferably at least about 3 and less than or equal to about 5 mm. 
         [0031]    The second section comprises, consists of, or consists essentially of a first end with an internal diameter C, a second end with an internal diameter D, a longitudinal axis extending from the first end to the second end, and a substantially circular internal surface along the longitudinal axis. Preferably, C is less than B, D is greater than C, and the first end of the second section is in fluid flow communication with the second end of the first section. Having internal diameter D greater than internal diameter C provides the benefits of: 1) giving the user a tactile feedback when seating a hollow tube into the port, and 2) preventing the hollow tube from being unintentionally squeezed back out of the port, which is more likely if D is not greater than C. Internal diameter C can be at least about 2 and less than about 6, preferably at least about 2 and less than or equal to about 5 mm. Internal diameter D can be at least about 2 and less than or equal to about 6 mm, preferably at least about 3 and less than or equal to about 5 mm. 
         [0032]    The third section comprises, consists of, or consists essentially of a first end with an internal diameter E, a second end with an internal diameter F, a longitudinal axis extending from the first end to the second end, and a substantially circular internal surface along the longitudinal axis. Preferably, E is less than C, F is greater than E, and the first end of the third section is in fluid flow communication with the second end of the second section. Having internal diameter F greater than internal diameter E provides the benefits of: 1) giving the user a tactile feedback when seating a hollow tube into the port, and 2) preventing the hollow tube from being unintentionally squeezed back out of the port, which is more likely if F is not greater than E. Internal diameter E can be at least about 1 and less than or equal to about 4 mm, preferably at least about 1 and less than or equal to about 3.5 mm. Internal diameter F can be at least about 1 and less than or equal to about 4.5 mm, preferably at least about 1 and less than or equal to about 4 mm. 
         [0033]    The base section comprises, consists of, or consists essentially of a first end with a diameter G and a second end. Preferably, G is less than E and the first end of the base section is in fluid flow communication with the second end of the third section. Internal diameter G can be at least about 0.1 and less than or equal to about 3 mm, preferably at least about 0.2 and less than or equal to about 1.5 mm. 
         [0034]    The port can also further comprise a transition section disposed between the second section and the third section. The transition section can comprise, consist of, or consist essentially of a first end with an inside diameter of D and a second end with an inside diameter E. Preferably, the first end of the transition section is in fluid flow communication with the second end of the second section, and the second end of the transition section is in fluid flow communication with the first end of the third section. 
         [0035]    At least one of the first, second, third, base, and optional transition sections of the port can be in fluid flow communication with other sections by connection of such section(s) to a neighboring section, such as by gluing, welding, fusion, etc. As an example, one or more of the sections, as a separate component, can be bonded or otherwise attached to another section or sections which is also a separate component. Also, at least one of the first, second, third, base, and optional transition sections of the port can be in fluid flow communication with another section by being a part of a solid unit along with such other neighboring section. As one example of such, the sections can all be a part of a single molded or formed port, or any two or more of the sections can each be a part of a single molded or formed component of the port. 
         [0036]    The second end of the base section is in fluid flow communication with an open inlet port of a microfluidic testing device. Such fluid flow communication can be by connection of the second end of the base section with the open port, or the port and microfluidic testing device can be in fluid flow communication as components of a single molded or formed unit. Preferably, the connection of the second end of the base section to the open inlet port is a circumferentially sealed connection. 
         [0037]    The port is preferably constructed of an elastomeric material, and more preferably is a thermoplastic elastomer such as a Kraton polymer material available from Kraton Polymers US LLC. 
         [0038]    The port is preferably configured to accept a fluid sample and pass the fluid sample to the microfluidic testing device through the open inlet port. The first section is configured to accept and substantially seal the outer surface of a tip of a device having an outside diameter greater than B and less than A. Such device can be a syringe or test tube luer adaptor, and the tip is preferably substantially sealed at a location between the first and second ends of the first section. 
         [0039]    The second section is configured to accept and substantially seal the outer surface of a hollow tube having an outside diameter greater than or equal to C and less than D. Preferably, the outer surface of the hollow tube is sealed at or near the first end of the second section. In addition, the first end of the third section, having a smaller diameter than such hollow tube, can serve as a stop for such hollow tube. 
         [0040]    Similarly, the third section is configured to accept and substantially seal the outer surface of a hollow tube having an outside diameter greater than or equal to E and less than C and less than F. Preferably, the outer surface of the hollow tube is sealed at or near the first end of the third section. In addition, the first end of the base section, having a smaller diameter than such hollow tube, can serve as a stop for such hollow tube. 
         [0041]    The first end of the first section can further comprise an outside surface having disposed thereon at least two tabs. Such tabs are preferably configured to receive at least one threaded portion of a syringe, thereby locking the syringe to the first end of the first section. The threaded portion of the syringe can be engaged by twisting it onto the tabs in order to lock the syringe in place. 
         [0042]    The second and third sections can also be of a frusto-conical shape. 
         [0043]    The port can also be a part of a microfluidic testing device comprising, consisting of, or consisting essentially of the sample port as described above, a first layer, a second layer disposed above the first layer and defining an open inlet port, and a component located between the first and second layers. The component(s) can include, but is not limited to, a pump, a chamber, a capillary, a reagent, an analyzer, and combinations thereof. The second end of the base section of the sample port is in fluid flow communication with the open inlet port defined by the second layer. 
         [0044]    In addition, the present invention includes a process for dispensing a fluid comprising, consisting of, or consisting essentially of utilizing the microfluidic testing device described above, or another fluid collection device containing such sample port as described above; inserting a fluid-containing device containing a fluid into the sample port until substantially sealed; and transferring the fluid into the microfluidic testing device to a location between the first and second layers through the open inlet port. When the fluid-containing device is either a syringe or a test tube luer adaptor or some other such device having a tip with a diameter greater than B and less than A, then the outside surface of the tip is sealed within the first section upon insertion. 
         [0045]    The fluid-containing device can also be a hollow tube having an outside diameter equal to or greater than C and less than D. Upon insertion, the outside surface of such hollow tube is sealed within the second section at a location at or near the first end of the second section. 
         [0046]    The fluid-containing device can also be a hollow tube having an outside diameter equal to or greater than E and less than C and less than F. Upon insertion, the outside surface of such hollow tube is sealed within the third section at a location at or near the first end of the third section. 
         [0047]    An embodiment of the present invention will now be described with reference to  FIGS. 1A through 1E . 
         [0048]    Referring now to  FIG. 1A , therein is provided a cross-sectional view of a sample introduction port  10  connected to, or a part of, a microfluidic testing device  132 . 
         [0049]    A first section  102  of a frusto-conical shape has a first end  104  with an internal diameter A and a second end  106  with an internal diameter B, wherein B is less than A. 
         [0050]    A second section  108  has a first end  110  with an internal diameter C, a second end  112  with an internal diameter D, a longitudinal axis  114  extending from the first end  110  to the second end  112 , and a substantially circular internal surface  116  along the longitudinal axis  114 , wherein C is less than B, D is greater than C, and wherein the first end  110  of the second section  108  is in fluid flow communication with the second end  106  of the first section  102 . 
         [0051]    A third section  118  has a first end  120  with an internal diameter E, a second end  122  with an internal diameter F, the same longitudinal axis  114  extending from the first end  120  to the second end  122 , and substantially circular internal surface  116  along the longitudinal axis  114 , wherein E is less than C, wherein F is greater than E, and wherein the first end  120  of the third section  118  is in fluid flow communication with the second end  112  of the second section  108 . 
         [0052]    A base section  124  has a first end  126  with a diameter G and a second end  128 , wherein G is less than E, wherein the first end  126  of the base section  124  is in fluid flow communication with the second end  122  of the third section  118 . 
         [0053]    The second end  128  of the base section  124  is in fluid flow communication with an open inlet port  130  of microfluidic testing device  132 . The port  10  can also include a transition section  134  disposed between the second section  108  and the third section  118  having a first end  134   a  with an inside diameter of D and a second end  134   b  with an inside diameter E, wherein the first end  134   a  of the transition section  134  is in fluid flow communication with the second end  112  of the second section  108 , and wherein the second end  134   b  of the transition section  134  is in fluid flow communication with the first end  120  of the third section  118 . 
         [0054]    The first end  104  of the first section  102  can further include an outside surface  136  having disposed thereon at least two tabs  138 . Further, microfluidic testing device  132  can also include a capillary or channel or chamber  140 . 
         [0055]    Referring now to  FIG. 1B , therein is provided a cross-sectional view of the sample introduction port connected to the microfluidic testing device from  FIG. 1A , and also depicting the insertion of the tip of a device into the port. 
         [0056]    The first section  102  is configured to accept and substantially seal the outer surface  142  of a tip of a device  144 , wherein the tip of device  144  has an outside diameter greater than B and less than A. The tip of device  144  can be tapered as shown and is considered to be that portion which is capable of being accepted by first section  102 . 
         [0057]    Referring now to  FIG. 1C , therein is provided a cross-sectional view of the sample introduction port  10  connected to the microfluidic testing device from  FIG. 1A , and also depicting the insertion of the tip of a syringe  144  into the port  10  with engagement of the syringe threads  146  to tabs  138 . 
         [0058]    Referring now to  FIG. 1D , therein is provided a cross-sectional view of the sample introduction port  10  connected to the microfluidic testing device from  FIG. 1A  also depicting the insertion of a hollow tube into the port  10 . 
         [0059]    The second section  108  is configured to accept and substantially seal an outer surface  148  of a hollow tube  150  having an outside diameter greater than or equal to C and less than D. The outer surface  148  of the hollow tube  150  is sealed at or near the first end  110  of the second section  108 . The first end  120  of the third section  118  can serve as a stop for the hollow tube  150 . Having internal diameter D greater than internal diameter C provides the benefits of: 1) giving the user a tactile feedback when seating hollow tube  150  into the port, and 2) preventing hollow tube  150  from being unintentionally squeezed back out of the port, which is more likely if D is not greater than C. 
         [0060]    Referring now to  FIG. 1E , therein is provided a cross-sectional view of the sample introduction port  10  connected to the microfluidic testing device from  FIG. 1A  also depicting the insertion of a hollow tube into the port  10 . 
         [0061]    The third section  118  is configured to accept and substantially seal an outer surface  152  of a hollow tube  154  having an outside diameter greater than or equal to E and less than C and less than F. The outer surface  152  of the hollow tube  154  is sealed at or near the first end  120  of the third section  118 . The first end  126  of the base section  124  can serve as a stop for the hollow tube  154 . Having internal diameter F greater than internal diameter E provides the benefits of: 1) giving the user a tactile feedback when seating hollow tube  154  into the port, and 2) preventing hollow tube  154  from being unintentionally squeezed back out of the port, which is more likely if F is not greater than E. 
         [0062]    While not depicted in the Figures, it is to be understood that a hollow tube having an outside diameter which is less than or equal to G can be inserted into the base section  124 . In addition, with reference to  FIG. 1A , it is to be understood that a hollow tube having an outside diameter less than or equal to the outside diameter of the open inlet port  130  can be further inserted into open inlet port  130 . 
         [0063]    Referring now to  FIG. 2 , therein is provided a cross-sectional view of a sample introduction port  20  representing another embodiment of the present invention. 
         [0064]    A wall  202 , which is circular along its length, has a first end  204  having a first end internal diameter  206  and a second end  208  having a second end internal diameter  210 . The wall  202  can be constructed of an elastomeric material, preferably a thermoplastic elastomer. The wall  202  has an inner surface  212  defining at least a first sealing point  214  having a first sealing point internal diameter  216  and a second sealing point  218  having a second sealing point internal diameter  220 . The first sealing point  214  and the second sealing point  218  are spaced between first end  204  and second end  208 . Second sealing point  218  is also located between first sealing point  214  and second end  208 . Wall  202  further has an intermediate internal diameter  222  at a location intermediate to the first sealing point  214  and the second sealing point  218 . First sealing point internal diameter  216  is less than the first end internal diameter  206  and is less than the intermediate internal diameter  222 . Second sealing point internal diameter  220  is less than the intermediate internal diameter  222  and less than the first sealing point internal diameter  216  and is less than the second end internal diameter  210 . 
         [0065]    The second end  208  of the port  20  can be in fluid flow communication with an open inlet port  224  of a microfluidic testing device  226 . Such fluid flow communication can be by connecting second end  208  to open inlet port  224 , as described above, preferably as a circumferentially sealed connection. The second end  208  and the microfluidic testing device  226  can also each be a part of a single molded or formed unit. 
         [0066]    Port  20  is configured to accept a fluid sample and pass the fluid sample to the microfluidic testing device  226  through open inlet port  224 . 
         [0067]    The first end internal diameter  206  can be at least about 2 and less than or equal to about 6 mm, more preferably at least about 3 and less than or equal to about 5 mm. The second end internal diameter  210  can be at least about 1 and less than or equal to about 4.5 mm, more preferably at least about 1 and less than or equal to about 4 mm. 
         [0068]    The first sealing point internal diameter  216  can be at least about 2 and less than about 6 mm, more preferably at least about 2 and less than or equal to about 5 mm. 
         [0069]    The second sealing point internal diameter  220  can be at least about 1 and less than or equal to about 4 mm, more preferably at least about 1 and less than or equal to about 3.5 mm. 
         [0070]    The intermediate internal diameter  222  can be at least about 2 and less than or equal to about 6 mm, more preferably at least about 3 and less than or equal to about 5 mm. 
         [0071]    The port  20  is configured to accept and substantially seal the outer surface of a tip of a device wherein the tip of the device has an outside diameter greater than the first sealing point internal diameter  216  and less than the first end internal diameter  206 . The tip of such device can be tapered as shown and is considered to be that portion which is capable of being accepted by port  20 . Such device can be, but is not limited to, a syringe or test tube luer adaptor. 
         [0072]    The port  20  is also configured to accept and substantially seal the outer surface of a hollow tube having an outside diameter greater than or equal to the first sealing point internal diameter  216  and less than the first end internal diameter  206 . The outer surface of the hollow tube is preferably sealed at or near the first sealing point  214 , and the second sealing point  218  can serve as a stop for the hollow tube. Having the first sealing point internal diameter  216  less than the intermediate internal diameter  222  provides the benefits of: 1) giving the user a tactile feedback when seating the hollow tube into the port  20 , and 2) preventing the hollow tube from being unintentionally squeezed back out of the port  20 , which is more likely if the first sealing point internal diameter  216  is not less than the intermediate internal diameter  222 . 
         [0073]    The port  20  is also configured to accept and substantially seal the outer surface of a hollow tube having an outside diameter greater than or equal to the second sealing point internal diameter  220  and less than the first sealing point internal diameter  216  and less than the second end internal diameter  210 . The outer surface of such hollow tube is preferably sealed at or near the second sealing point  218 . Having the second sealing point internal diameter  220  less than the second end internal diameter  210  provides the benefits of: 1) giving the user a tactile feedback when seating the hollow tube into the port  20 , and 2) preventing the hollow tube from being unintentionally squeezed back out of the port  20 , which is more likely if the second sealing point internal diameter  220  is not less than the second end internal diameter  210 . 
         [0074]    It is also to be understood that a hollow tube having an outside diameter which is less than or equal to the diameter of the open inlet port  224  can be inserted into the into open inlet port  224 . 
         [0075]    The first end  204  of the wall  202  can further comprise an outside surface  228  having disposed thereon at least two tabs  230 . The tabs  230  are configured to receive at least one threaded portion of a syringe, thereby locking the syringe to the first end of the wall (similar to the description regarding  FIG. 1C ). 
         [0076]    Referring now to  FIGS. 3A-3C , therein are depicted a method for collecting and delivering a blood sample to a microfluidic testing device. 
         [0077]    Referring to  FIG. 3A , therein is provided a schematic illustration depicting a sample acquisition system and apparatus for acquiring a sample of blood from a vein. 
         [0078]    The method includes utilizing a sample acquisition system/assembly comprising, consisting of, or consisting essentially of: an intravenous needle  300 ; a tube  302  having a first end  304  and a second end  306 ; a test tube luer adaptor  308  comprising a male luer  310 , which can be tapered as shown, and a female luer  312 , wherein the female luer  312  comprises a hollow needle  314  in fluid flow communication with the male luer  310 ; a test tube  316  having an open end  318  sealed with an elastomeric sealing member  320 , wherein the test tube  316  and the elastomeric sealing member  320  define a space  322  having a pressure lower than atmospheric pressure, preferably less than 1 atmosphere. 
         [0079]    The intravenous needle  300  is connected in fluid flow communication with the first end  304  of the tube  302 , and the second end  306  of the tube  302  is connected in fluid flow communication with the male luer  310  of the test tube luer adaptor  308 . The system can also comprise a connector  324  having a first end  326  and a second end  328 , wherein the first end  326  of connector  324  is connected in fluid flow communication to the second end  306  of tube  302  and wherein the second end  328  of connector  324  is connected in fluid flow communication to the male luer  310 , thereby establishing a fluid flow communication between the second end  306  of tube  302  and male luer  310 . 
         [0080]    Intravenous needle  300  is inserted into a vein containing blood, establishing a pathway for blood to flow from the vein to the test tube luer adaptor  308 . 
         [0081]    Referring now to  FIG. 3B , test tube  316  is inserted into the female luer  312  of the test tube luer adaptor  308  such that the hollow needle  314  punctures through the elastomeric sealing member  320 , thereby drawing blood from the vein into space  322  of test tube  316 . The second end  306  of tube  302  (or the second end  328  of connector  324 , if used) is removed from the male luer  310 . 
         [0082]    Referring now to  FIGS. 3C and 3D , the male luer  310  is then inserted into the sample introduction port described above. 
         [0083]    As shown in  FIG. 3C , the male luer  310  is inserted into the first section  102  of sample port  10  until substantially sealed within the first section  102 . Blood is then transferred from space  322  into the microfluidic testing device  132  through the open inlet port  130 . 
         [0084]    As shown in  FIG. 3D , the male luer  310  is inserted into port  20  through first end  204  until substantially sealed at a location between first end  204  and first sealing point  214 . Blood is then transferred from space  322  into the microfluidic testing device  226  through open inlet port  224 . 
         [0085]    Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by anyone of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). 
         [0086]    Further, unless expressly stated otherwise, the term “about” as used herein is intended to include and take into account variations due to manufacturing tolerances and/or variabilities in process control. 
         [0087]    Changes may be made in the construction and the operation of the various components, elements and assemblies described herein, and changes may be made in the steps or sequence of steps of the methods described herein without departing from the spirit and the scope of the invention as defined in the following claims.