PCR-like performance of rapid test with permselective tunable nanotrap

Area of Science:

• Biotechnology
• Medical Diagnostics
• Infectious Disease Research

Background:

• Rapid and sensitive detection of SARS-CoV-2 is crucial for controlling virus transmission, particularly in pre-symptomatic and asymptomatic individuals.
• Existing rapid tests, such as lateral flow assays (LFAs), often lack sufficient sensitivity for early or low viral load detection.

Purpose of the Study:

• To develop and evaluate bioengineered enrichment tools for lateral flow assays (LFAs) to enhance the sensitivity and specificity of COVID-19 detection.
• To assess the performance of these enhanced LFAs in detecting SARS-CoV-2, nucleocapsid (N) proteins, and immunoglobulin G (IgG) in various clinical sample types.

Main Methods:

• Development of bioengineered enrichment tools for lateral flow assays (LFAs), termed BEETLES^2.
• Utilizing BEETLES^2 for the enrichment of SARS-CoV-2, N proteins, and IgG within a 3-minute operational timeframe.
• Testing the method on clinical samples from 62 individuals (42 positive, 20 healthy controls), including samples with low and intermediate viral loads.

Main Results:

• BEETLES^2 demonstrated a 3-minute enrichment process, improving the limit of detection by up to 20-fold compared to standard LFAs.
• Diagnostic evaluation showed BEETLES^2 achieved a sensitivity of 88.1%, specificity of 100%, and accuracy of 91.9%.
• In contrast, commercial LFAs alone achieved only 14.29% sensitivity, 100% specificity, and 41.94% accuracy on the same clinical samples.

Conclusions:

• BEETLES^2 significantly enhances the sensitivity and specificity of LFAs for detecting SARS-CoV-2, N proteins, and IgG.
• The permselective and tunable nature of BEETLES^2 allows for effective enrichment in nasopharyngeal/oropharyngeal swabs, saliva, and blood serum.
• This technology enables reliable, sensitive, and rapid point-of-care testing, facilitating early diagnosis and management of COVID-19.