Field optimized assay devices, methods, and systems

摘要

A portable unitary device handheld diagnostic device can be operated with minimal power requirement and provides ease of operation as well as low cost communication of diagnostic data from remote locations. The device can provide nucleic-acid based diagnostics with minimal training, little to no sample preparation, and generates diagnostic data in about 45 minutes. A system can enable point of care transmission from any location globally using a low cost satellite-based data link technique, for example, Short Burst Data (SBD), combined with data encoding.

主权项

1. A point of care medical device, comprising:
a medical diagnostic or treatment device with at least one sensor and configured to generate digital data responsively to the at least one sensor; the at least one sensor being adapted to detect and generate a data signal indicative of: a result of an assay of a biological substance, a diagnostic indicator of a human, a treatment outcome, or a condition of diagnostic or treatment device; a communications component configured to store and compress digital data that is responsive to the data signal and to wirelessly transmit said digital data; and the communications component being configured to transmit, at transmission times, in packets of less than a kilobyte size, wherein the packets include the digital data in encrypted form, wherein the medical diagnostic or treatment device comprises: a removable cartridge with on or more microfluidic channels therein; a pressure generating device constructed to generate a positive or negative pressure; a storage unit comprising a reservoir that is separate from the pressure generating device and constructed to store the pressure generated by the pressure generating device; a flow control device including a valve or sealing plug that controls flow through one or more of the microfluidic channels; and a controller configured to control the flow control device to selectively apply the stored pressure from the storage unit to the one or more microfluidic channels so as to move a reagent and/or the biological substance through the one or more microfluidic channels, wherein the pressure generating device is constructed to generate the pressure by manual actuation, the reservoir is constructed to withhold the stored pressure from the cartridge until the flow control device is controlled by the controller to apply the stored pressure to the one or more microfluidic channels, the one or more microfluidic channels comprise a first inlet for a sample, a second inlet for a reagent, a suction port, and a third inlet, the third inlet is disposed downstream of the first and second inlets and upstream of the suction port, and the third inlet allows air to be drawn into the one or more microfluidic channels by a negative pressure applied from the reservoir to the suction port, until the third inlet is sealed by the sealing plug of the flow control device.