Dataset from A Rapid, Sensitive, Point-of-Care, Antigen-Based Diagnostics for SARS-CoV-2

Background: A rapid, sensitive, low-cost diagnostic device for early detection of COVID-19 supports better patient management and reduces pressure on healthcare systems. Quantitative real-time PCR is the standard for early diagnosis but relies on bulky, expensive equipment and trained personnel. Most FDA emergency use authorized tests follow this PCR-based model, requiring nucleic acid extraction, amplification, and thermal cycling. Studies have shown wide variation in detection limits across current nucleic acid and antigen tests, which reinforces the need for point-of-care antigen diagnostics with performance levels comparable to PCR.

Materials/Methods: The study was designed as an interdisciplinary effort to address testing challenges. The approach focused on developing a portable diagnostic system capable of rapid and sensitive detection of intact SARS-CoV-2 in small volumes of patient samples, such as anterior, nasopharyngeal, or oropharyngeal swabs. The system was built around an inexpensive, disposable, and mass-producible microfluidic cartridge.

Outcome/Impact: The outcome was to produce a portable diagnostic system that could deliver rapid and sensitive results at the point-of-care, with performance comparable to PCR-based assays. The intended impact was to provide a practical, low-cost, and scalable alternative to current PCR-based systems, improving access to early COVID-19 detection outside of laboratory settings.