Validation of Rapid and Economic Colorimetric Nanoparticle Assay for SARS-CoV-2 RNA Detection in Saliva and Nasopharyngeal Swabs

Autor: María Armesto, Mathias Charconnet, José M. Marimón, Cristina Lía Fernández Regueiro, Jia Jia, Tingdong Yan, Ane Sorarrain, Marek Grzelczak, María Sanromán, Mónica Vicente, Boris Klempa, Javier Zubiria, Yuan Peng, Lei Zhang, Jianhua Zhang, Charles H. Lawrie
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Biosensors, Vol 13, Iss 2, p 275 (2023)
Druh dokumentu: article
ISSN: 2079-6374
DOI: 10.3390/bios13020275
Popis: 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 × 105 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 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.
Databáze: Directory of Open Access Journals