Microneedle-based skin patch for blood-free rapid diagnostic testing

Abstract

Rapid diagnostic tests are one of the most commonly used tests to detect and screen for infectious diseases in the developing world. While these tests are simple, inexpensive, and readily available, they rely on finger-prick blood sampling, which requires trained medical personnel, poses risks of infection, and can complicate cooperation in young children, asymptomatic individuals, and communities with blood taboos. Here, we report a novel microneedle-based skin patch for the rapid detection of protein biomarkers in dermal interstitial fluid. Sample collection is facilitated by a hydrophilic hollow microneedle array that autonomously extracts and transports interstitial fluid to an antibody-based lateral flow test strip via surface tension for colorimetric antigen detection. We employ a simple gold enhancement treatment to enhance the detection sensitivity of this colloidal gold-based lateral flow assay and elucidate the underlying mechanism of this enhancement mechanism through experimental investigation. For proof-of-concept, this device was used to detect Plasmodium falciparum histidine-rich protein 2, a biomarker for malaria infection, which could be detected at concentrations as low as 8 ng/mL. Each test can be completed in <20 min and requires no equipment. To the best of our knowledge, this work is the first demonstration of a microneedle-based lateral flow assay for rapid protein detection in dermal interstitial fluid. In addition to its simplicity, minimally invasive nature, and low cost, this diagnostic device can be readily adapted to detect other protein biomarkers in interstitial fluid, making it a promising tool for point-of-care testing.

Hollow Microneedle Array Fabrication with Rational Design to Prevent Skin Clogging in Transdermal Drug Delivery

“…Besides, these skin insertions show apparent correlation with the recent literature. 48,49 The tapered PICNT-MN array was viewed in SEM after repeated skin insertions and cleaning with ethanol and DI water (Fig. 6C).…”

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“…An example is a recent report on the use of a hollow microneedle test strip to extract the ISF and transport it to a colorimetric lateral flow immunoassay to detect malaria infection in less than 20 min. [ 122 ] Such ISF‐based rapid point‐of‐care testing can be highly valuable in low resource settings in developing countries where the access to advanced clinical laboratories is limited.…”

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“…The targeted antigen is trapped between two antibodies at the test line, and therefore, the signal intensity is proportional to the amount of analyte in the sample. Many liquid biological samples, including urine, saliva, perspiration, serum, plasma, whole blood, and other fluids, can also be analyzed with LFIA [42][43][44]. Numerous nanoparticles (NPs), including colloidal gold nanoparticles (AuNPs), quantum dots (QDs), fluorescent nanodiamond (FND), carbon black, selenium nanoparticles, and lanthanide-doped phosphors, have been employed as reporters.…”