Facilitating self-testing with a fast, accurate, and simplified shelf-stable colorimetric LAMP system for Mpox and...

The rapid and accurate detection of viral infections is essential for effective disease management and prevention. Quantitative polymerase chain reaction (qPCR) remains the gold standard for viral detection due to its high sensitivity and specificity. However, its limitations-including the need for specialized equipment, trained personnel, and longer processing times-make it impractical for at-home or rapid testing. Although numerous point-of-care assays based on isothermal nucleic acid amplification have been developed, they often lack the simplicity and adaptability required for self-testing in non-laboratory settings such as at home. To address this, we developed and validated the SCOLAR (Shelf-stable Colorimetric LAMP system for Rapid self-testing of viruses) system, a simplified, portable, and accurate diagnostic tool designed for self-testing of Mpox and SARS-CoV-2 infections. The SCOLAR system employs novel lyophilized colorimetric loop-mediated isothermal amplification (LAMP) beads, a customized sample lysis buffer, and smartphone-assisted RGB color analysis for interpreting results. Validation was conducted using 24 mock Mpox skin swabs, 32 wastewater samples, and 104 clinical SARS-CoV-2 nasopharyngeal swabs, with comparisons to an in-house qPCR assay. The SCOLAR system demonstrated an analytical sensitivity of below 10 copies/μL for all targets within 15 min. Diagnostic performance for mock Mpox samples exhibited 93.8 % sensitivity and 100 % specificity, while wastewater samples achieved 100 % sensitivity and specificity. SARS-CoV-2 swabs had 96 % sensitivity and 100 % specificity. The system also proved effective for self-testing by untrained individuals. SCOLAR offers a reliable, easy-to-use platform for rapid self-testing, with potential for broader applications in public health strategies to enhance pandemic preparedness and response.