| Autor: |
Gonçalo Doria, Carla Clemente, Eduardo Coelho, João Colaço, Rui Crespo, Andrei Semikhodskii, Helder Mansinho, Magno Dinis, Maria Fernanda Carvalho, Manuela Casmarrinha, Cátia Samina, Ana Cristina Vidal, Francisca Delarue, Susana Graúdo, Ana Catarina Santos, David Peças, Olga Carreira, Raquel Marques, Carina Gaspar, Orfeu Flores |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
International Journal of Infectious Diseases, Vol 123, Iss , Pp 1-8 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
1201-9712 |
| DOI: |
10.1016/j.ijid.2022.07.042 |
| Popis: |
Objectives: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase–PCR method. Methods: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples. Results: The assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19. Conclusion: This lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2’s N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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