An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour

• DOI: 10.1016/j.ijid.2022.07.042
• Publication Date: 2022-07-23T00:43:12Z
• Authors: Gonçalo Doria; Carla Clemente; Eduardo Coelho; João Colaço; Rui Crespo; Andrei Semikhodskii; Helder Mansinho; Magno Dinis; Maria Fernanda Ca...; Manuela Casmarrinha; Cátia Samina; Ana Cristina Vidal; Francisca Delarue; Susana Graúdo; Ana Catarina Santos; David Peças; Olga Carreira; Raquel Marques; Carina Gaspar; Orfeu Flores
• Keywords: Gold standard (test); Point-of-Care Testing; Point of care

The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to gold standard real-time reverse transcriptase-PCR method.The study conducted following nonprobability sampling ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal 191) clinical samples.The demonstrated 95.19% sensitivity and 100% specificity for detection SARS-CoV-2 crude samples 78.95% samples. It also successfully detected currently predominant variants concern (Beta B.1.351, Delta B.1.617.2, Omicron B.1.1.529) be inert against potential cross-reactions other common respiratory pathogens that cause infections present similar symptoms COVID-19.This pocket-sized relies on an amplification SARS-CoV-2's N E genes, taking just 50 minutes sample result, with only 2 hands-on time. presents good when samples, enabling low-cost, real-time, rapid, accurate identification at the point care, which is important both management population screening, as tool break chain transmission pandemic, especially low-resources environments.