Biological fluid sample assessment

Inventors

Skafidas, Efstratios • Ming, Hsien • LIANG, You • Huynh, Duc • Nguyen, Thanh • Erlichster, Michael

Assignees

MX3 Diagnostics Inc

Abstract

A method of assessing a bodily fluid sample on a test strip may involve applying a periodic signal with a first electrode located at a first location in a microfluidic channel of the test strip, monitoring the applied periodic signal with a second electrode located at a second location in the microfluidic channel, and using a third electrode located at a third location in the microfluidic channel as a reference electrode. The method may also include: collecting the bodily fluid sample in the microfluidic channel; continuing to apply the periodic signal, monitor the periodic signal and use the third electrode as a reference electrode while collecting the bodily fluid sample; and determining that the bodily fluid sample is sufficient for analyzing, based at least in part on the applied and monitored periodic signal.

Core Innovation

The disclosed invention is a system and method for assessing a bodily fluid sample on a microfluidic test strip. A microfluidic channel receives the bodily fluid sample, and a first electrode, a second electrode, and a third electrode are positioned at locations within the microfluidic channel. The analysis device applies a periodic signal with the first electrode, monitors the applied periodic signal with the second electrode, and uses the third electrode as a reference electrode during collection of the bodily fluid sample.

The invention determines that the bodily fluid sample is sufficient for analyzing by identifying a period of stability in the monitored periodic signal. The sufficiency determination is based at least in part on the applying and monitoring of the periodic signal, including identifying a period of stability consistent with sample presence in the microfluidic channel. In this way, the system decides whether the bodily fluid sample volume is sufficient for analysis using stability-based behavior of the monitored periodic signal.

In additional embodiments, the electrodes can have reconfigurable functions, and the analysis device reconfigures the functions of the first, second, and third electrodes while collecting the bodily fluid sample. The device continues applying the periodic signal and monitoring the periodic signal using the third electrode as a reference electrode, including after reconfiguration. In some embodiments, the applied and monitored periodic signals are used to determine at least one of sample flow rate or sample viscosity by comparing signals generated using different electrode configurations, and the system can provide user prompts or alerts when the monitored periodic signal indicates stability versus instability.

Claims Coverage

The independent claims cover three main variants of the sufficiency-assessment concept: fixed-function electrodes, reconfigurable electrode functions during collection, and a corresponding method implementation with reconfigurable electrodes. Across the independent claims, the key common inventive elements are periodic-signal application, monitoring at multiple electrode locations, reference-electrode use, and sufficiency determination based on applied and monitored periodic signals, including stability behavior.

Across the independent claims, the inventive coverage centers on determining bodily-fluid-sample sufficiency using applied and monitored periodic signals obtained from electrodes in a microfluidic test strip, including reference-electrode use and stability-based determination. The claim set further differentiates between fixed-function electrodes and embodiments that reconfigure electrode functions during sample collection while continuing periodic-signal monitoring.

Stated Advantages

Documented Applications