Biological Fluid Collection Device and Biological Fluid Separation and Testing System

Abstract

A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

What is claimed is: 
     
         1 . A biological fluid separation device, comprising:
 a rotatable body having a center of rotation, an outer periphery, and a body inlet, the body inlet adapted to receive a multi-component blood sample;   a separation chamber defined within the rotatable body and in fluid communication with the body inlet and having a chamber outlet spaced apart from the body inlet, the separation chamber adapted to receive the multi-component blood sample; and   a blood component chamber defined within the rotatable body and in fluid communication with the chamber outlet,   wherein when the separation chamber contains the multi-component blood sample and a rotational force is applied to the rotatable body, a first blood component of the multi-component blood sample passes from the separation chamber into the blood component chamber and a second blood component of the multi-component blood sample is retained within the separation chamber,   wherein the blood component chamber is disposed adjacent the center of rotation and the separation chamber is disposed adjacent the outer periphery of the rotatable body, and   wherein the body inlet includes an engagement portion configured to receive a transfer device for closed transfer of a multi-component blood sample to the separation device.   
     
     
         2 . The biological fluid separation device of  claim 1 , wherein the first blood component is a plasma component of the multi-component blood sample and the second blood component is a cellular component of the multi-component blood sample 
     
     
         3 . The biological fluid separation device of  claim 1 , further comprising a diagnostic chamber in fluid communication with the blood component chamber. 
     
     
         4 . The biological fluid separation device of  claim 1 , wherein the rotatable body is disc-shaped. 
     
     
         5 . The biological fluid separation device of  claim 1 , wherein the blood component chamber receives the first blood component of the multi-component blood sample upon the rotatable body being rotated by a processing instrument. 
     
     
         6 . The biological fluid separation device of  claim 1 , further comprising a diagnostic chamber in fluid communication with the blood component chamber and including a detection zone readable by a processing instrument. 
     
     
         7 . The biological fluid separation device of  claim 1 , wherein the engagement portion comprises a recess configured to receive a deformable wall member of the transfer device. 
     
     
         8 . The biological fluid separation device of  claim 1 , wherein the engagement portion comprises threads configured to threadably engage a portion of the transfer device. 
     
     
         9 . The biological fluid separation device of  claim 1 , wherein all portions of the blood component chamber are radially closer to the center of rotation than any portion of the separation chamber. 
     
     
         10 . The biological fluid separation device of  claim 1 , wherein the center of rotation is defined within the outer periphery. 
     
     
         11 . The biological fluid separation device of  claim 1 , wherein the separation device is configured such that a rotational force at a first rotation rate applied to the rotatable body separates the multi-component blood sample in the separation chamber into a first component and a second component, and reduction of the rotational force from the first rotation rate to a second rotation rate, which is less than the first rotation rate, causes the second blood component of the multi-component blood sample to be driven towards the center of rotatable body through a flow channel into the blood component chamber while the second component of the multi-component blood sample is retained within the separation chamber.