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

MX3 Diagnostics Inc

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

The invention relates to a single-use test strip for sampling a bodily fluid. The test strip includes multiple layers of a substrate material and a microfluidic channel formed between at least some of the multiple layers. Multiple electrodes are positioned on one of the multiple layers and are positioned and partially exposed within the microfluidic channel for electrochemical analysis.

A region at or near an entrance to the microfluidic channel includes a surface feature configured to selectively limit the flow of bubbles present in the sample into the microfluidic channel. The surface feature also selectively limits the flow of at least one of bubbles or debris into the microfluidic channel, so that bubbles are trapped at the region and are prevented from passing through the microfluidic channel.

The disclosed approach further includes using the saliva test strip in combination with a handheld saliva analyzer. In use, a portion of a saliva sample is taken up into an inlet on a free end of the saliva test strip, where the inlet leads to the entrance of the microfluidic channel, and the saliva portion is passed along the microfluidic channel over the multiple electrodes.

Claims Coverage

The partial content includes two independent claims. The first covers a bodily-fluid sampling test strip with a bubble-limiting entrance region and multiple electrodes within a microfluidic channel. The second covers a saliva-analyte concentration determination method using that saliva test strip and a handheld saliva analyzer, including bubble or debris trapping and electrode-based measurement along the microfluidic channel.

Across the independent claims, the shared inventive focus is a microfluidic-channel test strip with electrodes positioned within the channel and an entrance-region surface feature that selectively limits bubble flow into the channel by trapping the bubbles. The method claim integrates this strip with a handheld saliva analyzer to determine analyte concentration based on the sample passed over the electrodes after uptake through the inlet.

Stated Advantages

Documented Applications