1. Validation of Rapid and Economic Colorimetric Nanoparticle Assay for SARS-CoV-2 RNA Detection in Saliva and Nasopharyngeal Swabs.
- Author
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Armesto, María, Charconnet, Mathias, Marimón, José M., Fernández Regueiro, Cristina Lía, Jia, Jia, Yan, Tingdong, Sorarrain, Ane, Grzelczak, Marek, Sanromán, María, Vicente, Mónica, Klempa, Boris, Zubiria, Javier, Peng, Yuan, Zhang, Lei, Zhang, Jianhua, and Lawrie, Charles H.
- Subjects
NANOPARTICLES ,RESOURCE-limited settings ,SARS-CoV-2 ,SALIVA ,MEDICAL personnel ,RNA - Abstract
Even with the widespread uptake of vaccines, the SARS-CoV-2-induced COVID-19 pandemic continues to overwhelm many healthcare systems worldwide. Consequently, massive scale molecular diagnostic testing remains a key strategy to control the ongoing pandemic, and the need for instrument-free, economic and easy-to-use molecular diagnostic alternatives to PCR remains a goal of many healthcare providers, including WHO. We developed a test (Repvit) based on gold nanoparticles that can detect SARS-CoV-2 RNA directly from nasopharyngeal swab or saliva samples with a limit of detection (LOD) of 2.1 × 10
5 copies mL−1 by the naked eye (or 8 × 104 copies mL−1 by spectrophotometer) in less than 20 min, without the need for any instrumentation, and with a manufacturing price of <$1. We tested this technology on 1143 clinical samples from RNA extracted from nasopharyngeal swabs (n = 188), directly from saliva samples (n = 635; assayed by spectrophotometer) and nasopharyngeal swabs (n = 320) from multiple centers and obtained sensitivity values of 92.86%, 93.75% and 94.57% and specificities of 93.22%, 97.96% and 94.76%, respectively. To our knowledge, this is the first description of a colloidal nanoparticle assay that allows for rapid nucleic acid detection at clinically relevant sensitivity without the need for external instrumentation that could be used in resource-limited settings or for self-testing. [ABSTRACT FROM AUTHOR]- Published
- 2023
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