Biological fluid sample assessment
Inventors
Skafidas, Efstratios • Ming, Hsien • LIANG, You • Huynh, Duc • Nguyen, Thanh • Erlichster, Michael
Assignees
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Publication Number
US-11703436-B2
Publication Date
2023-07-18
Expiration Date
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 invention relates to a point-of-care test strip method for assessing a bodily fluid sample in a microfluidic channel or microfluidic sample chamber before initiating analysis. A periodic signal is applied with an electrode arrangement located at different locations within the microfluidic sampling fluidics of the test strip, while one or more electrodes monitor the applied periodic signal, and a reference electrode is used to support the assessment.
Sample sufficiency is determined by identifying a period of stability in the monitored periodic signals based at least in part on applying and monitoring the periodic signal. The stability period represents sufficient sample volume filling and consistency within acceptable bounds, and insufficiency is recognized when instability or stability outside a predetermined range is detected.
In additional embodiments, the signal behavior supports deriving characteristics such as sample flow rate and sample viscosity. The system initiates measurement during the identified period of stability, or prompts the user to continue collecting the bodily fluid sample when non-detection or instability indicates insufficient volume.
Claims Coverage
The independent claims cover electrode-based periodic-signal assessment of bodily fluid sample sufficiency on a test strip microfluidic channel or sample chamber, using an identified period of stability to control initiation of measurement. Three inventive features are described, with variants including fixed-function electrodes, reconfigurable-function electrodes, and at-least-four electrodes with multiple monitored signals.
Fixed-function electrode periodic signal sufficiency assessment
Applying a periodic signal with a first electrode at a first location in a microfluidic channel, monitoring the applied periodic signal with a second electrode at a second location, using a third electrode as a reference electrode, and determining that the bodily fluid sample is a sufficient volume for analyzing by identifying a period of stability in the monitored periodic signal.
Reconfigurable electrode periodic signal sufficiency assessment
Applying a periodic signal with a first, second, and third electrode each having a reconfigurable function, continuing to apply and monitor the periodic signal while collecting the bodily fluid sample, reconfiguring the functions of the electrodes while collecting the sample, and determining that the bodily fluid sample is sufficient for analyzing based at least in part on the applied and monitored periodic signal.
At-least-four electrode stability-controlled measurement initiation
Applying a periodic signal with at least some of at least four electrodes located at different locations in a microfluidic sample chamber, monitoring the periodic signal with at least some of the electrodes to collect at least two monitored signals, identifying a period of stability in the monitored signals, and initiating measurement of the bodily fluid sample based on the identified period of stability.
Across the independent claims, sufficiency for analysis is controlled by applying a periodic signal with electrodes in test strip microfluidic sampling fluidics, monitoring one or more periodic-signal responses, using a reference electrode and, in one variant, reconfiguring electrode functions, identifying a period of stability in the monitored signals, and initiating measurement based on that stability period.
Stated Advantages
Avoiding false triggering from partial channel filling or transient bridging by using a period of stability in monitored periodic signals.
Allowing initiation of measurement based on a stability period that indicates sample sufficiency.
Enabling derivation of sample flow rate and sample viscosity from signal behavior in embodiments.
Providing user indications, including auditory, visual, or vibration signals, when sample is insufficient and prompting continued collection.
Documented Applications
Assessing a bodily fluid sample, including saliva, sweat, blood, and urine, on a point-of-care test strip to determine sufficient sample volume for analyzing before initiating measurement.
Handheld biological fluid analysis device use with auditory, visual, or vibration feedback based on sample sufficiency determinations.
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