Diagnostic accuracy of clinically applied nanoparticle-based biosensors at detecting SARS-CoV-2 RNA and surface proteins in pharyngeal swabs compared to RT-PCR as a reference test

ABSTRACT

Introduction

Nanoparticle-based biosensors (NPBs) are point-of-care diagnostic platforms that can be used for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high accuracy.

Areas covered

EBSCOhost Web, Embase, ProQuest, PubMed/MEDLINE, Scopus, Web of Science, and WHO Global Literature on Coronavirus Disease 2019 (COVID-19) were searched for relevant records published from 1 November 2019 to 30 April 2022. Records reporting original data on the accuracy of clinically applied nanoparticle-based biosensors at detecting SARS-CoV-2 RNA and surface proteins from pharyngeal swab specimens were considered. Findings were reported based on the PRISMA 2020 statement. The QUADAS-2 tool was used for assessment of quality and risk of bias among the included studies.

Expert opinion

A total of 50 relevant records were identified, of which 13 were included. The included studies explored the diagnostic performance of 13 clinically applied distinct nanoparticle-based biosensors in a total of 789 pharyngeal swabs collected from 376 COVID-19 patients and 413 otherwise healthy individuals. The mean sensitivity, specificity, and accuracy were 97.07%, 94.43%, and 96.91%, respectively, in comparison to RT-qPCR as the reference test. Considering their ease-of-operation, portability, low-cost manufacturing, NPBs could be considered suitable candidate diagnostic platforms for substituting RT-qPCR.

KEYWORDS:

• Biosensors
• nanobiosensors
• nanoparticle-based biosensors
• diagnostic accuracy
• sensitivity
• specificity
• coronavirus disease 2019
• COVID-19
• SARS-CoV-2

Article highlights

• A systematic search was conducted on 7 literature databases.

• 13 studies, corresponding to 13 different types of nanoparticle-based biosensors, were included.

• Clinical validation of these biosensors for diagnosis of COVID-19 on 789 pharyngeal swab specimens revealed a sensitivity, specificity, and accuracy of 97.07%, 94.43%, and 96.91%, respectively.

• Gold nanoparticles were the most commonly used type of nanoparticle, and optical biosensors delivered the highest quality of evidence with regard to sample size.

Declaration of interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737159.2022.2135434

Additional information

Funding

Funding that has been provided by Infectious and Tropical Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran (Grant Agreement No. IR.TBZMED.REC.1400.326) is gratefully acknowledged.