A biological fluid sampling device for collecting a blood sample from a separate vascular access device and for ejecting a portion of the collected sample to a point-of-care testing device for analysis is provided. The biological fluid sampling device includes a body enclosing a reservoir. The reservoir has an internal volume sufficient to contain enough blood for use in a diagnostic test. The sampling device further includes: an access lumen extending from a distal end of the body for establishing fluid communication between a separate vascular access device and the reservoir; an outflow lumen also in fluid communication with the reservoir; and a removable vented cap attached to the outflow lumen including a gas permeable vent in gaseous communication between the reservoir and ambient air. In addition, several sample and transfer devices are provided for obtaining a sample from a subject and transferring the sample to a point-of-care testing device.

A biological fluid sampling device for collecting a blood sample from a separate vascular access device and for ejecting a portion of the collected sample to a point-of-care testing device for analysis is provided. The biological fluid sampling device includes a body enclosing a reservoir. The reservoir has an internal volume sufficient to contain enough blood for use in a diagnostic test. The sampling device further includes: an access lumen extending from a distal end of the body for establishing fluid communication between a separate vascular access device and the reservoir; an outflow lumen also in fluid communication with the reservoir; and a removable vented cap attached to the outflow lumen including a gas permeable vent in gaseous communication between the reservoir and ambient air. In addition, several sample and transfer devices are provided for obtaining a sample from a subject and transferring the sample to a point-of-care testing device.

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.

A blood sampling transfer device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. 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 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 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.

A blood separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood separation device is able to separate a plasma portion from a cellular portion. After separation, the blood separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood separation device 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 blood separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood separation 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.

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.

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.

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

A blood sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer.

A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge.