A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid 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 lancing device has a domed structure that can be depressed by application of a force by a user's finger so as to expose the tip of a needle. The domed structure is configured to move from a non-depressed state to a depressed state in a manner that allows for the piercing of the user's finger. The domed structure may then recoil to its original, non-depressed position upon the user ceasing to apply the force. Other embodiments of a lancing device are disclosed.

Various collection devices, systems and methods relating to the use of devices with open microfluidic channels disposed within a housing defining a lumen. These devices make use of microneedles passed through apertures to induce fluid flow into microfluidic channel networks for collection and analysis. The device can be actuated via button when placed on the skin of a patient to collect a fluid sample, such as a blood draw.

In some examples, a diagnostic device includes a reusable part to receive a container of a fluid, the reusable part reusable for a plurality of diagnostic tests. The diagnostic device further includes a disposable part detachably attached to the reusable part and comprising a sample collector to collect a target sample of a living being. The diagnostic device further includes a tester comprising a fluid channel to transport the fluid to combine the fluid and the target sample to form a fluid combination, and to use the fluid combination to diagnose a condition of the target sample.

Systems, methods, and kits are disclosed for collection, labeling and analyzing biological samples containing nucleic acid in conjunction with collecting at least one ridge and valley signature of an individual. Such devices and methods are used in forensic, human identification, access control and screening technologies to rapidly process an individual's identity or determine the identity of an individual.

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed. In some cases, the device itself may be shipped or analyzed. For example, in some embodiments, a portion of the device may be sealed such that the substrate is contained within an airtight portion of the device, optionally containing desiccant. Other aspects are generally directed at other devices for receiving blood (or other bodily fluids), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

The present invention relates to a device for collecting body fluids including (a) a fluid receiving part including a fluid receiving space in which an internal low pressure less than an external atmospheric pressure is formed; (b) a fluid collection part including a hollow microstructure connected to form an open system with the fluid receiving space of the fluid receiving part; and (c) a microstructure hollow barrier for blocking the hollow of the microstructure to maintain the internal low pressure formed in the fluid receiving means.

An electrochemical sensing system includes a working electrode and a reference electrode, which can at least partially be disposed in a housing. At least a portion of the working electrode includes rhodium metal. An electrical circuit is disposed in the housing and configured to be electronically coupled to the electrodes. The electrical circuit is operative to: (a) bias the working electrode at a voltage of less than about 0.4 V, and (b) measure a current corresponding to the concentration of the target analyte. A communications module is electrically coupled to the electrical circuit and configured to display a concentration of the target analyte, and/or communicate data between the electrical circuit and an external device. The electrodes are movable between a first configuration in which the electrodes are substantially disposed inside the housing, and a second configuration in which at least a portion of the electrodes is disposed outside the housing.

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is 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 substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member. 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.