Integrating advanced Microfluidic lateral flow systems with a finger-prick blood collection cartridge to create an all-in-one platform for point-of-care diagnostics.

Rapid, point-of-care tests are critical for early diagnosis of disease and detection of biological threats. Lateral flow immunoassays (LFIAs) are well-suited for point-of-care testing due to their ease of use and straightforward readout. However, limitations in sensitivity, quantification, and integration into sample-to-result systems indicate the need for further advancements. This paper introduces a novel all-in-one LFIA that integrates a test strip with optimized geometry within a newly designed finger-prick blood collection cartridge. This innovative system offers an efficient solution for the detection and quantification of hepatitis B antigens, combining precision and user-friendliness in a single device. To enhance assay performance, the conventional test strip's response to the target protein was significantly improved by incorporating a constricted test zone and upstream mixing elements. To meet self-testing requirements, the blood collection cartridge incorporates an innovative two-step rotation mechanism that simplifies sample collection, processing, and application onto the test strip. Numerical simulations of flow dynamics and antibody-antigen interactions using COMSOL guided the optimization of the test strip geometry, achieving a substantial improvement in the limit of detection from 1.78 ± 0.08 to 0.55 ± 0.04 ng/mL compared to the classic rectangular strip geometry. The optimized design also increased analytical sensitivity from 1.4 ± 0.1 to 2.8 ± 0.1 RU.mL/ng. The system demonstrated complete functionality, from sample collection to analyte quantification. This integrated, user-friendly platform provides an advanced, sample-to-result diagnostic solution for detecting disease markers from finger-prick blood samples. Its simplicity makes it suitable for point-of-care testing, including home use by non-professionals.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Razieh Salahandish reports financial support was provided by Mitacs Canada. Razieh Salahandish has patent #63/643,523 pending to Scanbo. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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