Limits and Opportunities of SARS-CoV-2 Antigen Rapid Tests: An Experienced-Based Perspective

Verena Schildgen,Sabrina Demuth,Jessica Lüsebrink,Oliver Schildgen

doi:10.3390/pathogens10010038

Abstract

Background: Due to the steadily rising case numbers of SARS-CoV-2 infections worldwide, there is an increasing need for reliable rapid diagnostic devices in addition to existing gold standard PCR methods. Actually, public attention is focused on antigen assays including lateral flow tests (LFTs) as a diagnostic alternative. Therefore, different LFTs were analyzed regarding their performance in a clinical setting. Material and Methods: A pilot sample panel of 13 bronchoalveolar fluids (BALFs) and 60 throat washing (TW) samples with confirmed PCR results, as well as eight throat washes invalid by PCR, were tested with the BIOCREDIT test (RapiGEN), the PanbioTM assay (Abbott), and the SARS-CoV-2 rapid antigen test (Roche). Conclusion: The analyzed antigen test showed an interassay correlation of 27.4%, with overall specificities ranging from 19.4% to 87.1%, while sensitivities of the respective tests ranged between 33.3% and 88.1%. Because these assays did not entirely meet all high expectations, their benefit has to be carefully evaluated for the respective test strategy and setting.

Highlights

In December 2019, the public became aware of the new betacoronavirus SARS-CoV-2, due to an outbreak in Wuhan, China [1]
All samples used in this study had been characterized previously with the Altona two target PCR assay as a gold standard, according to national and international recommendations
This gold standard PCR was successfully validated and certified by analyzing external controls supplied within a national round robin trial organized by INSTAND e.V. and the positive control RNA provided by the German National Reference Centre for coronaviruses

Summary

Introduction

In December 2019, the public became aware of the new betacoronavirus SARS-CoV-2, due to an outbreak in Wuhan, China [1]. It has been shown that these PCRs represent the diagnostic gold standard [3], valuable time passes until the result is available (https://www.nytimes.com/2020/08/04/us/virus-testing-delays.html). Due to the steadily rising case numbers of SARS-CoV-2 infections worldwide, there is an increasing need for reliable rapid diagnostic devices in addition to existing gold standard PCR methods. Conclusion: The analyzed antigen test showed an interassay correlation of 27.4%, with overall specificities ranging from 19.4% to 87.1%, while sensitivities of the respective tests ranged between 33.3% and 88.1%. Because these assays did not entirely meet all high expectations, their benefit has to be carefully evaluated for the respective test strategy and setting

Methods

Results

Conclusion