Significance High-frequency testing is urgently needed to help prevent the spread of COVID-19. Here, we introduce Low-cost Electrochemical Advanced Diagnostic (LEAD), a diagnostic test that detects SARS-CoV-2 within 6.5 min, costs $1.50 per unit, and uses easily assembled materials such as human angiotensin-converting enzyme 2, modified graphite leads, and a plastic vial. LEAD presents sensitivity comparable to the gold-standard methods (limit of detection for the viral spike protein = 229 fg⋅mL -1 ) and displays an excellent performance profile when tested using clinical saliva (100.0% sensitivity, 100.0% specificity, 100.0% accuracy) and nasopharyngeal/oropharyngeal (88.7% sensitivity, 86.0% specificity, 87.4% accuracy) samples. Finally, no cross-reactivity with other viruses was detected and the test displayed a viable shelf-life of 5 d when stored at 4 °C. COVID-19 has led to over 3.47 million deaths worldwide and continues to devastate primarily middle- and low-income countries. High-frequency testing has been proposed as a potential solution to prevent outbreaks. However, current tests are not sufficiently low-cost, rapid, or scalable to enable broad COVID-19 testing. Here, we describe LEAD (Low-cost Electrochemical Advanced Diagnostic), a diagnostic test that detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6.5 min and costs $1.50 per unit to produce using easily accessible and commercially available materials. LEAD is highly sensitive toward SARS-CoV-2 spike protein (limit of detection = 229 fg⋅mL −1 ) and displays an excellent performance profile using clinical saliva (100.0% sensitivity, 100.0% specificity, and 100.0% accuracy) and nasopharyngeal/oropharyngeal (88.7% sensitivity, 86.0% specificity, and 87.4% accuracy) samples. No cross-reactivity was detected with other coronavirus or influenza strains. Importantly, LEAD also successfully diagnosed the highly contagious SARS-CoV-2 B.1.1.7 UK variant. The device presents high reproducibility under all conditions tested and preserves its original sensitivity for 5 d when stored at 4 °C in phosphate-buffered saline. Our low-cost and do-it-yourself technology opens new avenues to facilitate high-frequency testing and access to much-needed diagnostic tests in resource-limited settings and low-income communities.
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