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Assessment of the Diagnostic Performance of a Novel SARS-CoV-2 Antigen Sealing Tube Test Strip (Colloidal Gold) as Point-of-Care Surveillance Test

Authors :
Alessandro Medoro
Sergio Davinelli
Serena Voccola
Gaetano Cardinale
Daniela Passarella
Nicola Marziliano
Mariano Intrieri
Source :
Diagnostics, Vol 12, Iss 5, p 1279 (2022)
Publication Year :
2022
Publisher :
MDPI AG, 2022.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant outbreaks have highlighted the need of antigen-detecting rapid diagnostic tests (Ag-RDTs) that can be used at the point-of-care (POC). Although many Ag-RDTs have been approved for SARS-CoV-2 detection, studies demonstrating the clinical performance of Ag-RDTs against variants of concern, especially the new Omicron variant, are limited. The aim of this study was to evaluate the diagnostic sensitivity and specificity of the AMAZING COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) in 584 early symptomatic and asymptomatic participants (age range 0–90 years). The performance of this Ag-RDT was assessed by comparing its results with reverse transcription RT-PCR (rRT-PCR). One hundred twenty positive samples were also analyzed with rRT-PCR to discriminate Omicron and Delta/Kappa variants (72.50% Omicron; 27.50% Delta/Kappa). Overall, the Ag-RDT showed high positive and negative percent values of 92.52% (95% CI, 86.61–95.95%) and 98.05% (95% CI, 96.41–98.95%), respectively, as well as an overall diagnostic accuracy of 96.92% (95% CI, 95.17–98.16%). Taken together, these data indicate that this inexpensive and simple-to-use Ag-RDT presents excellent analytical performance and can reliably detect Omicron and Delta/Kappa variants.

Details

Language :
English
ISSN :
20754418
Volume :
12
Issue :
5
Database :
Directory of Open Access Journals
Journal :
Diagnostics
Publication Type :
Academic Journal
Accession number :
edsdoj.1a0ad5aa704f483492014383f73e71d7
Document Type :
article
Full Text :
https://doi.org/10.3390/diagnostics12051279