Accuracy of NanoBiosensor-based Molecular Assays for Diagnosis of COVID-19 Compared to RT-PCR as a Reference Test: a Systematic Review

Abstract

Nanobiosensors (NPBs) are biosensing platforms that incorporate nanomaterials for robust detection of biologic particles, and can be applied for clinical diagnosis of COVID-19 with acceptable accuracy. We sought to evaluate the diagnostic accuracy of NPBs as an emerging alternative to RT-PCR in the clinical identification of SARS-CoV-2. Our aim was to systematically synthesize evidence to justify the diagnostic value of NPBs as a suitable replacement for RT-PCR in the clinical identification of the novel coronavirus. Methods: We searched seven literature databases including EBSCOhost Web, Embase, ProQuest, PubMed/MEDLINE, Scopus, Web of Science, and WHO LitCOVID to identify original records concerned with development and application of NPBs in the clinical diagnosis of COVID-19 that were published from November 1, 2019 to April 30, 2022. We then calculated the indicators of diagnostic power including sensitivity, specificity and accuracy. As part of a joint clinical investigation, we collected a total of 72 saliva specimens 24 age-matched patients with RT-PCR-confirmed COVID-19 on days 1, 3 and 5 following their hospitalization, which were tested using the rapid antigen diagnostic kit for SARS-CoV-2. Results: We included 13 studies that reported original findings regarding the use of different NPBs in the clinical identification of COVID-19 via molecular identification of viral surface proteins and RNA in NPS/OPS. In total, 789 NPS/OPS samples gathered from 376 COVID-19+ and 413 COVID-19– participants were surveyed by the included studies using a total of 13 distinct NPBs. Compared to the reference test or RT-qPCR, NPBs yielded a mean sensitivity of 97.07%, a mean specificity of 94.43% and a mean accuracy of 96.91%. As for the clinical investigation, saliva-based test using rapid antigen kits conferred mean accuracy rates of 83.3%, 58.3% and 62.5% on days 1, 3 and 5, respectively.