Integrated device for self-collecting and automated pre-processing of biological fluids

An integrated sample collection device for self-collection of a blood sample from a user comprising:

• a housing configured to be held by a user;
• a foot at the bottom of the housing configured to tilt the integrated sample collection device while it rests on a flat surface at an upward tilting angle of 3 degrees to 30 degrees;
• a contact-activated penetrating member disposed at least partially in the housing and configured to penetrate skin;
• a first and a second capillary tube disposed in the housing and each having a distal end configured to collect blood released from the penetrating member that penetrates the skin and an actuatable penetrating proximal end;
• a first vacuum-assisted blood collection container at least partially disposed in the housing and configured to temporarily fluidically connect to the first capillary tube to receive at least a portion of the collected blood from the first capillary tube upon an actuation force applied to the first vacuum-assisted blood collection container;
• a second vacuum-assisted blood collection container at least partially disposed in the housing and configured to temporarily fluidically connect to the second capillary tube to receive at least a portion of the collected blood from the second capillary tube upon an actuation force applied to the second vacuum-assisted blood collection container;
• wherein the first and the second vacuum-assisted blood collection container generate a vacuum and the vacuum is less than or equal to −13.1 kPa relative to environmental pressure;
• wherein the first and the second vacuum-assisted blood collection containers are fluidically connected to the first and the second capillary tubes for receiving at least a portion of the collected blood by:
• a first adapter and a second adapter connected to a proximal end of the first and the second capillary tubes;
• a first and a second transfer needle connected to the first and the second adapter;
• a first cap and second cap having a low permeable barrier coating and a thickness connected to the first and the second vacuum-assisted blood collection container;
• wherein
• the first and the second transfer needles comprise a bevel and a depth of the first and second transfer needle bevel is shorter than the thickness of the first and the second cap;
• a stabilizing agent for stabilizing collected blood in the first and/or second capillary tube, the first and/or second vacuum-assisted blood collection container, or both;
• wherein the first vacuum-assisted blood collection container contains the stabilizing agent that is an RNA stabilization solution configured to lyse red blood cells and stabilize RNA immediately after collection in the first vacuum-assisted blood collection container for pre-processing of a gene expression assay;
• wherein the second vacuum-assisted blood collection container comprises a pre-processing agent that is a cell culture medium configured to initiate a blood cell culture immediately after collection and during a transport time for pre-processing of a cell culture based assay, including a cytokinesis-block micronucleus (CBMN) assay to decrease a sample processing time at a laboratory.