Saliva test strip and method
Inventors
NGUYEN, Thanh Cong • Skafidas, Efstratios • HUYNH, Duc Hau • Erlichster, Michael • Nguyen, Duc Phuong • Ming, Hsien • Chana, Gursharan • Lee, Ting Ting • ABEYRATHNE, Chathurika Darshani • LIANG, You • KILPATRICK, Trevor John • Luther, Michael • Luther, Alan Dayvault
Assignees
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Publication Number
US-11701036-B2
Publication Date
2023-07-18
Expiration Date
Abstract
A test strip for sampling a bodily fluid may include multiple layers of a substrate material, an adhesive between at least some of the multiple layers, and a microfluidic channel formed between at least some of the multiple layers. The test strip may further include multiple electrodes on one of the multiple layers, positioned and partially exposed within the microfluidic channel, an additional material positioned at or near an entrance to the microfluidic channel, to selectively limit the flow of at least one of bubbles or debris into the microfluidic channel, and at least one exit port in at least one of the multiple layers to allow for release of pressure from the test strip. In some embodiments, the test strip is a saliva analysis test strip. In some embodiments, the test strip includes multiple exit ports to prevent blockage of sample flow.
Core Innovation
A single-use saliva test strip for sampling a bodily fluid includes multiple layers of a substrate material bonded with an adhesive between at least some of the layers. The layers form a microfluidic channel between at least some of the multiple layers, and multiple electrodes on one of the layers are positioned and partially exposed within the microfluidic channel for electrochemical analyte measurement.
The strip includes an additional material positioned at or near an entrance to the microfluidic channel to selectively limit the flow of at least one of bubbles or debris into the microfluidic channel. This additional material prevents bubbles from passing through the microfluidic channel by trapping the bubbles, while being positioned to avoid blocking biomarker-containing saliva.
The strip also includes multiple exit ports in at least one of the layers to allow for release of pressure from the test strip and to prevent disruption of sample flow through the microfluidic channel due to blockages. The exit ports include a first exit port in a top layer and at least one second exit port in a side edge of the test strip.
Claims Coverage
The document includes three independent claims directed to a layered saliva test strip architecture with a microfluidic channel, electrode placement, bubble/debris limiting at the channel entrance, and multiple exit ports for pressure release and blockage tolerance. A further independent claim recites a method using the strip for determining analyte concentration with a handheld saliva analyzer.
Layered microfluidic saliva test strip with partially exposed electrodes
A test strip for sampling a bodily fluid comprising multiple layers of a substrate material, an adhesive between at least some of the multiple layers, a microfluidic channel formed between at least some of the multiple layers, and multiple electrodes on one of the multiple layers positioned and partially exposed within the microfluidic channel.
Entrance material for selectively limiting bubbles or debris
A test strip further including an additional material positioned at or near an entrance to the microfluidic channel to selectively limit the flow of at least one of bubbles or debris into the microfluidic channel.
Pressure-release exit ports to prevent flow disruption
A test strip having multiple exit ports in at least one of the multiple layers to allow for release of pressure from the test strip and to prevent disruption of sample flow through the microfluidic channel due to blockages, wherein the multiple exit ports comprise a first exit port in a top layer and at least one second exit port in a side edge of the test strip.
Saliva method with strip uptake and handheld analyzer determination
A method of using a saliva test strip to determine a concentration of at least one analyte in a saliva sample comprising taking up a portion of a saliva sample into an inlet on a free end contacting the saliva sample, preventing bubbles from passing through the microfluidic channel by trapping the bubbles in the additional material, passing the portion of the saliva sample along the microfluidic channel over the multiple electrodes, and determining the concentration using a handheld saliva analyzer into which a connection end opposite the free end is placed.
Overall, the independent claims focus on a layered saliva test strip with a microfluidic channel and multiple electrodes partially exposed therein, combined with an entrance additional material for selectively limiting bubbles or debris and multiple exit ports configured to release pressure and prevent disruption of sample flow due to blockages, with the method claim tying these strip features to determining analyte concentration using a handheld saliva analyzer.
Stated Advantages
Prevents disruption of sample flow through the microfluidic channel due to blockages by using multiple exit ports for release of pressure.
Prevents bubbles from passing through the microfluidic channel by trapping bubbles in the additional material positioned at or near the entrance.
Allows release of pressure from the test strip to help maintain sample flow through the microfluidic channel.
Documented Applications
Determining concentration of at least one analyte in a saliva sample using a saliva test strip and a handheld saliva analyzer.
Sampling a bodily fluid with a test strip that is configured for electrochemical analyte measurement within a microfluidic channel.
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