Patent Description:
Blood sampling is a common health care procedure involving the withdrawal of at least a drop of blood from a patient. Blood samples are commonly taken from hospitalized, homecare, and emergency room patients either by finger stick, heel stick, or venipuncture. Blood samples may also be taken from patients by venous or arterial lines. Once collected, blood samples may be analyzed to obtain medically useful information including chemical composition, hematology, or coagulation, for example.

Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug effectiveness, and organ function. Blood tests may be performed in a clinical laboratory or at the point-of-care near the patient. One example of point-of-care blood testing is the routine testing of a patient's blood glucose levels which involves the extraction of blood via a finger stick and the mechanical collection of blood into a diagnostic cartridge. Thereafter, the diagnostic cartridge analyzes the blood sample and provides the clinician a reading of the patient's blood glucose level. Other devices are available which analyze blood gas electrolyte levels, lithium levels, and ionized calcium levels. Some other point-of-care devices identify markers for acute coronary syndrome (ACS) and deep vein thrombosis/pulmonary embolism (DVT/PE).

Despite the rapid advancement in point-of-care testing and diagnostics, blood sampling techniques have remained relatively unchanged. Blood samples are frequently drawn using hypodermic needles or vacuum tubes attached to a proximal end of a needle or a catheter assembly. In some instances, clinicians collect blood from a catheter assembly using a needle and syringe that is inserted into the catheter to withdraw blood from a patient through the inserted catheter. These procedures utilize needles and vacuum tubes as intermediate devices from which the collected blood sample is typically withdrawn prior to testing. These processes are thus device intensive, utilizing multiple devices in the process of obtaining, preparing, and testing blood samples. Each additional device increases the time and cost of the testing process.

Point-of-care testing devices allow for a blood sample to be tested without needing to send the blood sample to a lab for analysis. Thus, it is desirable to create a device that provides an easy, safe, reproducible, and accurate process with a point-of-care testing system.

A blood sample transferring device having the features as defined within the preamble of claim <NUM> is known from <CIT>.

Further background art for the present invention is described in <CIT>, <CIT>, Sartorius catalogue.

The present disclosure provides a biological fluid sampling transfer device, such as a blood sampling transfer device, that is adapted to receive a blood sample having a cellular portion and a plasma portion. After collecting the blood sample, the blood sampling transfer device is able to separate the plasma portion from the cellular portion. After separation, the blood sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood sampling transfer device of the present disclosure also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The sample stabilizer, can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. The blood sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

Some of the advantages of the blood sampling transfer device and the blood separation and testing system of the present disclosure over prior systems are that it is a closed system which reduces blood sample exposure, it provides passive and fast mixing of the blood sample with a sample stabilizer, it facilitates separation of the blood sample without transferring the blood sample to a separate device, and it is capable of transferring pure plasma to a point-of-care testing device. The blood sampling transfer device of the present disclosure enables integrated blood collection and plasma creation in a closed system without centrifugation. The clinician may collect and separate the blood sample and then immediately transfer the plasma portion to the point-of-care testing device without further manipulation. This enables collection and transfer of plasma to the point-of-care testing device without exposure to blood. In addition, the blood sampling transfer device of the present disclosure minimizes process time by processing the blood within the blood sampling transfer device and without external machinery. Further, for tests which only require small amounts of blood, it eliminates the waste associated with blood collection and plasma separation with an evacuated tube.

In accordance with an embodiment of the present invention, a blood sampling transfer device adapted to receive a blood sample having a cellular portion and a plasma portion is claimed in claim <NUM>.

In one configuration, the first component is a reusable component. In another configuration, the second component is a disposable component. According to the invention, the filter is a tangential flow filter. The tangential flow filter is adapted to utilize a cross-flow filtration to separate the plasma portion from the cellular portion. In another configuration, the blood sampling transfer device includes an acoustic focus element that is adapted to oscillate the blood sample over the tangential flow filter. In yet another configuration, the inlet port is adapted to receive the blood sample via connection to a blood collection device. In one configuration, the outlet port is adapted for connection to a point-of-care testing device for closed transfer of a portion of the plasma portion from the transfer chamber to the point-of-care testing device. In another configuration, with the outlet port connected to the point-of-care testing device for closed transfer, the plasma portion is transferred from the transfer chamber to the point-of-care testing device upon actuation of the actuation member.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.

The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention.

However, it is to be understood that the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention.

Various point-of-care testing devices are known in the art. Such point-of-care testing devices include test strips, glass slides, diagnostic cartridges, or other testing devices for testing and analysis. Test strips, glass slides, and diagnostic cartridges are point-of-care testing devices that receive a blood sample and test that blood for one or more physiological and biochemical states. There are many point-of-care devices that use cartridge based architecture to analyze very small amounts of blood at a patient's bedside without the need to send the sample to a lab for analysis. This saves time in getting results over the long run but creates a different set of challenges versus the highly routine lab environment. Examples of such testing cartridges include the i-STAT® testing cartridge from the Abbot group of companies. Testing cartridges such as the i-STAT® cartridges may be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. The results of tests using such cartridges are quickly provided to the clinician.

However, the samples provided to such point-of-care testing cartridges are currently manually collected with an open system and transferred to the point-of-care testing cartridge in a manual manner that often leads to inconsistent results, or failure of the cartridge leading to a repeat of the sample collection and testing process, thereby negating the advantage of the point-of-care testing device. Accordingly, a need exists for a system for collecting and transferring a sample to a point-of-care testing device that provides safer, reproducible, and more accurate results. Accordingly, a point-of-care collecting and transferring system of the present disclosure will be described hereinafter. A system of the present disclosure enhances the reliability of the point-of-care testing device by: <NUM>) incorporating a more closed type of sampling and transfer system; <NUM>) minimizing open exposure of the sample; <NUM>) improving sample quality; <NUM>) improving the overall ease of use; and <NUM>) separating the sample at the point of collection.

<FIG> illustrate an exemplary embodiment of the present disclosure. Referring to <FIG>, a biological fluid sampling transfer device <NUM>, such as a blood sampling transfer device, of the present disclosure is adapted to receive a blood sample <NUM> having a cellular portion <NUM> and a plasma portion <NUM>. After collecting the blood sample <NUM>, the blood sampling transfer device <NUM> is able to separate the plasma portion <NUM> from the cellular portion <NUM>. After separation, the blood sampling transfer device <NUM> is able to transfer the plasma portion <NUM> of the blood sample <NUM> to a point-of-care testing device. The blood sampling transfer device <NUM> of the present disclosure also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer.

<FIG> illustrates an exemplary embodiment of the present disclosure. Referring to <FIG>, a biological fluid separation and testing system <NUM>, such as a blood separation and testing system, of the present disclosure includes a blood sampling transfer device <NUM> and a blood testing device or point-of-care testing device <NUM> engageable with the blood sampling transfer device <NUM> for closed transfer of a portion of the plasma portion <NUM> (<FIG>) from the blood sampling transfer device <NUM> to the blood testing device <NUM>. The blood testing device <NUM> is adapted to receive the plasma portion <NUM> to analyze the blood sample and obtain test results.

<FIG> illustrates an exemplary embodiment of the present disclosure. Referring to <FIG>, a blood sampling transfer system <NUM> of the present disclosure includes a reusable component <NUM> and a first disposable component <NUM> that is removably connectable to the reusable component <NUM> and a second disposable component <NUM> that is removably connectable to the reusable component <NUM>.

Referring to <FIG>, a blood sampling transfer device <NUM> includes a first component or reusable component <NUM> and a second component or disposable component <NUM> that is removably connected to the first component <NUM>. The blood sampling transfer device <NUM> is adapted to receive a blood sample <NUM> having a cellular portion <NUM> and a plasma portion <NUM>.

Referring to <FIG>, the first component <NUM> generally includes an actuation member <NUM>, a pair of internal miniature pumps <NUM>, a logic control board <NUM>, a power source <NUM>, an indicator element <NUM>, a first securement portion <NUM>, and a handle portion <NUM>. In one embodiment, the actuation member <NUM> includes a two-way power switch or power button <NUM>. In one embodiment, the power source <NUM> includes batteries <NUM>. In one embodiment, the indicator element <NUM> includes a colored LED.

Referring to <FIG>, the second component <NUM> generally includes an inlet port <NUM>, a flow channel <NUM> having an inlet channel <NUM> and an exit channel <NUM>, an exit port or outlet port <NUM> in fluid communication with the inlet port <NUM> via the flow channel <NUM>, a separation chamber <NUM> having a first chamber <NUM> and a second chamber or transfer chamber <NUM>, a filter <NUM> disposed within the flow channel <NUM> between the inlet port <NUM> and the outlet port <NUM>, an acoustic focus element <NUM>, and a second securement portion <NUM>. The first chamber <NUM> of the separation chamber <NUM> is defined between the inlet port <NUM> and the filter <NUM>. The second chamber <NUM> of the separation chamber <NUM> is defined between the filter <NUM> and the outlet port <NUM>.

The first component <NUM> and the second component <NUM> are removably connectable theretogether such that significant relative movement between the first component <NUM> and the second component <NUM> is prevented. In one embodiment, the first component <NUM> and the second component <NUM> are removably connectable theretogether via engagement of the first securement portion <NUM> of the first component <NUM> with the second securement portion <NUM> of the second component <NUM>. In other embodiments, similar connection mechanisms may be used. For example, a snap fit engagement mechanism or a friction fit engagement mechanism may be used. The second component <NUM> of the blood sampling transfer device <NUM> is adapted to receive a blood sample <NUM> therein. The blood sample <NUM> may include a cellular portion <NUM> and a plasma portion <NUM>.

With the first component <NUM> and the second component <NUM> connected, the inlet port <NUM> is adapted to receive the blood sample upon actuation of the actuation member <NUM> as discussed in more detail below. With the blood sample received within the blood sampling transfer device <NUM>, the pumps <NUM> provide a mechanism to oscillate the blood sample back and forth over the filter <NUM>. The pumps <NUM> are controlled by the logic control board <NUM>. The power source <NUM> provides power to the actuation member <NUM>.

Referring to <FIG> and <FIG>, the inlet port <NUM> of the blood sampling transfer device <NUM> is adapted to be connected to a blood collection set or blood collection device <NUM> to allow for the collection of a blood sample <NUM> into the blood sampling transfer device <NUM>. The inlet port <NUM> may be sized and adapted for engagement with a separate device, such as a needle assembly or IV connection assembly and, therefore, may include a mechanism for such engagement as is conventionally known. For example, in one embodiment, the inlet port <NUM> may include a luer lock or luer tip for engagement with an optional separate luer mating component of such a separate device for attachment therewith. For example, referring to <FIG> and <FIG>, the blood collection set <NUM> may include a luer component <NUM> for engagement with the inlet port <NUM> of the blood sampling transfer device <NUM>. In this manner, the inlet port <NUM> is connectable to the blood collection set <NUM> for the collection of a blood sample into the blood sampling transfer device <NUM>. In addition, a mechanism for locking engagement between the inlet port <NUM> and the blood collection set <NUM> may also be provided. Such luer connections and luer locking mechanisms are well known in the art. The blood collection set <NUM> may include a needle assembly, an IV connection assembly, a PICC line, an arterial indwelling line, or similar blood collection means.

The inlet port <NUM> may also include a resealable septum that is transitionable between a closed position and an open position. With the septum in an open position, a blood sample <NUM> may flow through the inlet port <NUM> to the first chamber <NUM> of the separation chamber <NUM> via the inlet channel <NUM> of the flow channel <NUM>.

Referring to <FIG>, the separation chamber <NUM> is sealed such that a cellular portion <NUM> of the blood sample <NUM> is contained within the first chamber <NUM> of the separation chamber <NUM> and the plasma portion <NUM> of the blood sample <NUM> can exit the first chamber <NUM> by passing through the filter <NUM> to the second or transfer chamber <NUM> as discussed below. Only the plasma portion <NUM> of the blood sample <NUM> is able to pass through the filter <NUM>.

The second component <NUM> of the blood sampling transfer device <NUM> also may include an acoustic focus element <NUM> and a valve or septum <NUM> (<FIG>) at the outlet port <NUM>. The outlet port <NUM> is adapted for connection to a point-of-care testing device <NUM> for closed transfer of a portion of the plasma portion <NUM> from the blood sampling transfer device <NUM> to the point-of-care testing device <NUM> via the outlet port <NUM> as described in more detail below. Referring to <FIG>, the outlet port <NUM> is in fluid communication with the second or transfer chamber <NUM>. The valve or septum <NUM> at the outlet port <NUM> is transitionable between a closed position and an open position. With the valve or septum <NUM> in an open position (<FIG>), the plasma portion <NUM> of the blood sample <NUM> may flow through the outlet port <NUM> to a blood testing device or a point-of-care testing device <NUM> (<FIG>).

In one embodiment, the acoustic focus element <NUM> is disposed within the second component <NUM> and oscillates the blood sample <NUM> over the filter <NUM> as shown in <FIG>. The acoustic focus element <NUM> may focus red blood cells to the center of the separation chamber <NUM> and the filter <NUM> prior to passing through the filter <NUM>.

In one embodiment, a portion of the flow channel <NUM> or the inlet port <NUM> may also include a layer of sample stabilizer. The sample stabilizer can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. In one embodiment, the layer of sample stabilizer may be disposed over the filter <NUM>. In other embodiments, the layer of sample stabilizer may be located anywhere between the inlet port <NUM> and the filter <NUM>. In this manner, as a blood sample <NUM> flows through the inlet port <NUM> and into the first chamber <NUM> of the separation chamber <NUM>, the blood sampling transfer device <NUM> provides passive and fast mixing of the blood sample <NUM> with the sample stabilizer.

The second component <NUM> of the blood sampling transfer device <NUM> includes a filter <NUM> disposed between the first chamber <NUM> and the second chamber <NUM> as shown in <FIG>. The filter <NUM> is adapted to trap the cellular portion <NUM> of the blood sample <NUM> within the first chamber <NUM> and allow the plasma portion <NUM> of the blood sample <NUM> to pass through the filter <NUM> to the second chamber <NUM> as shown in <FIG>. In one embodiment, the filter <NUM> includes a tangential flow filter. The tangential flow filter utilizes a cross-flow filtration to separate the plasma portion <NUM> from the cellular portion <NUM>.

In one embodiment, the filter <NUM> may be either hollow fiber membrane filters commercially available, or flat membrane filters, such as track-etch filters commercially available. Membrane filter pore size and porosity can be chosen to optimize separation of clean (i.e., red blood cell free, white blood cell free, and platelet free) plasma in an efficient manner. In another embodiment, the filter <NUM> includes a lateral flow membrane. In other embodiments, the filter <NUM> may comprise any filter that is able to trap the cellular portion <NUM> of the blood sample <NUM> within the first chamber <NUM> and allow the plasma portion <NUM> of the blood sample <NUM> to pass through the filter <NUM> to the second chamber <NUM>.

Referring to <FIG>, a blood testing device or point-of-care testing device <NUM> includes a receiving port <NUM> adapted to receive the outlet port <NUM> of the blood sampling transfer device <NUM>. The blood testing device <NUM> is adapted to receive the outlet port <NUM> of the blood sampling transfer device <NUM> for closed transfer of a portion of the plasma portion <NUM> (<FIG>) from the blood sampling transfer device <NUM> to the blood testing device <NUM>. The blood testing device <NUM> is adapted to receive the plasma portion <NUM> to analyze the blood sample and obtain test results.

As discussed above, the outlet port <NUM> of the blood sampling transfer device <NUM> may include a valve or septum <NUM> that is transitionable between a closed position and an open position. With the valve or septum <NUM> in an open position (<FIG>), the plasma portion <NUM> of the blood sample <NUM> may flow through the outlet port <NUM> to a blood testing device or a point-of-care testing device <NUM> (<FIG>).

In one embodiment, referring to <FIG>, the valve <NUM> may generally include a transfer channel <NUM>, a bellows or deformable wall member <NUM>, and a septum or barrier <NUM> having a first barrier wall <NUM> and a second barrier wall <NUM>. Referring to <FIG>, the valve <NUM> is in a closed position to prevent the plasma portion <NUM> of the blood sample <NUM> from flowing through the outlet port <NUM>. In this manner, the plasma portion <NUM> is sealed within the blood sampling transfer device <NUM>. Referring to <FIG>, the valve <NUM> is in an open position so that the plasma portion <NUM> of the blood sample <NUM> may flow through the outlet port <NUM> to a blood testing device or a point-of-care testing device <NUM> (<FIG>).

Referring to <FIG>, with the plasma portion <NUM> received within the transfer chamber <NUM> of the blood sampling transfer device <NUM> (<FIG>), the outlet port <NUM> of the blood sampling transfer device <NUM> is then positioned over the receiving port <NUM> of the point-of-care testing device <NUM>. Pushing down in the direction of arrow B compresses the deformable wall member <NUM> and opens up the first barrier wall <NUM> and the second barrier wall <NUM> of the septum <NUM> as shown in <FIG>. With the valve <NUM> in the open position, the plasma portion <NUM> of the blood sample <NUM> is allowed to flow through the outlet port <NUM> and the receiving port <NUM> to the point-of-care testing device <NUM> in a closed manner reducing exposure to the clinician and the patient.

The valve <NUM> of the blood sampling transfer device <NUM> only opens when the outlet port <NUM> is pressed upon the receiving port <NUM> of the point-of-care testing device <NUM>. This releases the isolated plasma portion <NUM> directly into the receiving port <NUM> of the point-of-care testing device <NUM>, thus mitigating unnecessary exposure to the patient's blood.

Referring to <FIG>, a blood sampling transfer system <NUM> of the present disclosure will now be discussed. The blood sampling transfer system <NUM> includes a reusable component <NUM> and a first disposable component <NUM> that is removably connectable to the reusable component <NUM> and a second disposable component <NUM> that is removably connectable to the reusable component <NUM>.

As will be described below, after use of a disposable component <NUM>, the disposable component <NUM> can be removed from the first component <NUM>, as shown in <FIG>, and the disposable component <NUM> can be disposed of into a biological hazard container. One advantage of the blood sampling transfer system <NUM> of the present disclosure is that a plurality of disposable components <NUM>, i.e., a first disposable component <NUM> and a second disposable component <NUM>, can be used with the reusable component <NUM>. In other embodiments, any number of disposable components can be used with the reusable component <NUM>. In this manner, the reusable component <NUM> which includes the actuation member <NUM> can be used repeatedly while the disposable components, including the relevant sharps, can be discarded. Once a disposable component <NUM> is used, it can be removed from the first component <NUM>, as shown in <FIG>, and the disposable component <NUM> can be disposed of into a biological hazard container. When it is desired to use the blood sampling transfer device <NUM> again, a new and clean disposable component can be selected and used with the reusable component <NUM>.

Referring to <FIG>, use of a blood sampling transfer device and blood separation and testing system of the present disclosure will now be described. Referring to <FIG> and <FIG>, the inlet port <NUM> of the blood sampling transfer device <NUM> is adapted to be connected to a blood collection set <NUM> to allow for the collection of a blood sample <NUM> into the blood sampling transfer device <NUM> as discussed above. Once the blood collection set <NUM> is connected to a patient, the actuation member <NUM> of the first component <NUM> is activated, e.g., the power switch <NUM> is pushed down, to draw the blood sample into the separation chamber <NUM> of the second or disposable component <NUM>. As this happens, the blood sample <NUM> is oscillated back and forth over the filter <NUM>. Also, as the blood sample <NUM> slowly fills the blood sampling transfer device <NUM>, it is collected and stabilized over a layer of sample stabilizer. Referring to <FIG>, the plasma portion <NUM> of the blood sample <NUM> may then flow through the filter <NUM> so that the plasma portion <NUM> is separated from the cellular portion <NUM>. The plasma portion <NUM> passes through the filter <NUM> and into the second or transfer chamber <NUM>. When the indicator element <NUM> of the first component <NUM> turns on, e.g., a green LED turns on, the clinician can stop the collection and continue to transfer the plasma portion <NUM> that has collected in the transfer chamber <NUM>. For example, the next step is to transfer the plasma portion <NUM> to a point-of-care testing device <NUM>.

After disconnecting the blood sampling transfer device <NUM> from the blood collection set <NUM> or other blood collection line, the blood sampling transfer device <NUM> may be engaged with a blood testing device <NUM>. Next, the outlet port <NUM> is placed over the receiving port <NUM> of the point-of-care testing device <NUM> as shown in <FIG>. Then, the power button <NUM> is depressed to advance the plasma portion <NUM> and to transfer the collected plasma portion <NUM> to the point-of-care testing device <NUM>. The blood testing device <NUM> is adapted to receive the outlet port <NUM> of the blood sampling transfer device <NUM> for closed transfer of a portion of the plasma portion <NUM> from the blood sampling transfer device <NUM> to the blood testing device <NUM>. The blood testing device <NUM> is adapted to receive the plasma portion <NUM> to analyze the blood sample and obtain test results. After that, the disposable component <NUM> can be removed from the first component <NUM>, as shown in <FIG>, and the disposable component <NUM> can be disposed of into a biological hazard container.

The blood sampling transfer device <NUM> advantageously allows for the following: a) a safe, closed system for rapidly separating a cellular portion into a clean plasma sample for transfer to a point-of-care testing device <NUM>; b) plasma to be efficiently generated by repeatedly recirculating a cellular portion through the filter <NUM>; c) separated plasma to be safely transferred to the point-of-care testing device <NUM> via a septum enabled outlet port <NUM>; d) a system that can easily accept a cellular portion from a number of different blood collection modalities through an onboard blood inlet port <NUM>; and e) optionally, acoustic focusing element <NUM> to be used to focus red blood cells in the fluidic pathway toward the center of the flow and away from the filter <NUM>, further enhancing the efficiency of the plasma separation in the filter <NUM>.

Some of the other advantages of the blood sampling transfer device and the blood separation and testing system of the present disclosure over prior systems are that it is a closed system which reduces blood sample exposure, it provides passive and fast mixing of the blood sample with a sample stabilizer, it facilitates separation of the blood sample without transferring the blood sample to a separate device, and it is capable of transferring pure plasma to the point-of-care testing device <NUM>. The blood sampling transfer device of the present disclosure enables integrated blood collection and plasma creation in a closed system without centrifugation. The clinician may collect and separate the blood sample and then immediately transfer the plasma portion to the point-of-care testing device <NUM> without further manipulation. This enables collection and transfer of plasma to the point-of-care testing device <NUM> without exposure to blood. In addition, the blood sampling transfer device of the present disclosure minimizes process time by processing the blood within the blood sampling transfer device and without external machinery. Further, for tests which only require small amounts of blood, it eliminates the waste associated with blood collection and plasma separation with an evacuated tube.

Claim 1:
A blood sampling transfer device (<NUM>) adapted to receive a blood sample (<NUM>) having a cellular portion (<NUM>) and a plasma portion (<NUM>), the blood sampling transfer device (<NUM>) comprising:
a first component (<NUM>) having two electrically driven internal miniature pumps (<NUM>) and an actuation member (<NUM>) including a two-way power switch (<NUM>); and
a second component (<NUM>) removably connected to the first component (<NUM>), the second component (<NUM>) comprising:
an inlet port (<NUM>),
a flow channel (<NUM>),
an outlet port (<NUM>), the inlet port (<NUM>) and the outlet port (<NUM>) in fluid communication via the flow channel (<NUM>),
a tangential flow filter (<NUM>) disposed within the flow channel (<NUM>) between the inlet port (<NUM>) and the outlet port (<NUM>),
a first chamber (<NUM>) defined between the inlet port (<NUM>) and the tangential flow filter (<NUM>), and
a transfer chamber (<NUM>) defined between the tangential flow filter (<NUM>) and the outlet port (<NUM>);
wherein with the first component (<NUM>) and the second component (<NUM>) connected, the inlet port (<NUM>) is adapted to receive the blood sample (<NUM>) upon actuation of the two electrically driven internal miniature pumps (<NUM>), wherein the tangential flow filter (<NUM>) is adapted to trap the cellular portion (<NUM>) in the first chamber (<NUM>) and allow the plasma portion (<NUM>) to pass through the tangential flow filter (<NUM>) and into the transfer chamber (<NUM>),
characterized in that
the tangential flow filter (<NUM>) is adapted to utilize a cross-flow filtration to separate the plasma portion (<NUM>) from the cellular portion (<NUM>), and wherein the two electrically driven internal miniature pumps (<NUM>) are suitable to provide a mechanism to oscillate the blood sample (<NUM>) back and forth over the tangential flow filter (<NUM>).