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. 2024 Nov 22;9(11):5792-5801.
doi: 10.1021/acssensors.4c00956. Epub 2024 Oct 25.

Lateral Flow-Based Skin Patch for Rapid Detection of Protein Biomarkers in Human Dermal Interstitial Fluid

Elizabeth C Wilkirson  1 , Danika Li  2 , Peter B Lillehoj  1   2
Affiliations

Lateral Flow-Based Skin Patch for Rapid Detection of Protein Biomarkers in Human Dermal Interstitial Fluid

Elizabeth C Wilkirson et al. ACS Sens. .

Abstract

Rapid diagnostic tests (RDTs) offer valuable diagnostic information in a quick, easy-to-use and low-cost format. While RDTs are one of the most commonly used tools for in vitro diagnostic testing, they require the collection of a blood sample, which is painful, poses risks of infection and can lead to complications. We introduce a blood-free point-of-care diagnostic test for the rapid detection of protein biomarkers in dermal interstitial fluid (ISF). This device consists of a lateral flow immunochromatographic assay (LFIA) integrated within a microfluidic skin patch. ISF is collected from the skin using a microneedle array and vacuum-assisted extraction system integrated in the patch, and transported through the lateral flow strip via surface tension. Using this skin patch platform, we demonstrate in situ detection of anti-tetanus toxoid IgG and SARS-CoV-2 neutralizing antibodies, which could be accurately detected in human ISF in <20 min. We envision that this device can be readily modified to detect other protein biomarkers in dermal ISF, making it a promising tool for rapid diagnostic testing.

Keywords: SARS-CoV-2; diagnostic; interstitial fluid; lateral flow immunoassay; microfluidic; skin; tetanus.

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Conflict of interest statement

The authors declare the following competing financial interest(s): E.C.W. and P.B.L. are co-inventors of a provisional patent application filed by Rice University on the subject of this work.

Figures

Figure 1
Figure 1
Overview of the skin patch design. (A) Exploded view depicting the individual layers of the patch. Topside (B) and internal (C) views of the assembled patch. Scale bars, 6 mm.
Figure 2
Figure 2
Anti-tetanus toxoid IgG levels in human blood and ISF. Concentration of anti-tetanus toxoid IgG in blood and dermal ISF sampled from four volunteers measured using a commercial ELISA kit. Each bar represents the mean ± standard deviation (SD) of two measurements (n = 2).
Figure 3
Figure 3
Characterization of the skin patch. (A) Sequential still frame images showing the extraction and transport of liquid through the patch (without the bandage tape) in an artificial skin model. Arrows indicate the location(s) of the liquid front. Time stamps (min:s) are in the upper right corner. (B) Test results of ISF samples with increasing concentration of anti-tetanus toxoid IgG antibody. The dashed box indicates the desired protective threshold concentration. (C) Test results of ISF samples spiked with anti-tetanus toxoid IgG, anti-diphtheria toxoid IgG, or anti-B. pertussis toxin IgG, and PBS which was used as a blank control.
Figure 4
Figure 4
In situ detection of anti-tetanus toxoid IgG in ISF using the skin patch and associated adverse effects. (A) MN insertion in the skin using a MN applicator (i); attachment of the patch to the skin (ii); application of vacuum pressure using a hand pump (iii), followed by removal of the pump and vacuum incubation (iv). (B) Observation of the test results. Inset shows a close-up view of the test result window. (C) Photographs of the forearm of a volunteer before MN insertion (i); immediately following MN insertion (ii); immediately after testing and removal of the skin patch (iii); 5 min after testing (iv); 6 h after testing (v); 24 h after testing (vi). Dashed boxes indicate the MN insertion sites.
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