Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods : Experiences of a general hospital

Copyright © 2020 Elsevier B.V. All rights reserved..

BACKGROUND: The COVID-19 Ag (Antigen) Respi-Strip assay is a new immunochromatographic diagnostic tool recently available for antigenic diagnosis of SARS-CoV-2. The proposed sensitivity is not higher than 60 %, but its high specificity allows both quick decisions for the management of patients and confirmation by molecular diagnosis for only negative tests. However, from the first tests performed, we suspected that the sensitivity observed with routine use was much lower than that announced by the manufacturer.

MATERIALS AND METHODS: Over a period of one month, we compared the negative results obtained with the COVID-19 Ag Respi-Strip kit with those obtained from qRT-PCR performed in a laboratory qualified for the molecular diagnosis of SARS-CoV-2. All samples tested were naso-pharyngeal smears from UTM-RT medium.

RESULTS: Of 774 patients tested, 714 negative samples were sent for confirmation, and 159 were found to be positive by qRT-PCR. The median positive percentage agreement was 23.9 % (95 % CI: 14.2 %-38.2 %). The Cohen's kappa score was 0.35.

CONCLUSION: Using this immunochromatographic assay as a triage test did not significantly reduce the number of samples outsourced for COVID-19 confirmation by qRT-PCR. In addition, even if the turn-around time is short, the assay is completely manual, which is not suitable for large volumes of routine samples. The sensitivity of this rapid test is poor, and improvements are needed to enhance its performance.

Errataetall:

CommentOn: Front Med (Lausanne). 2020 May 08;7:225. - PMID 32574326

Media Type:

Electronic Article

Year of Publication:

2020

Contained In:

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - Vol. 129 (2020), p. 104472

Language:

English

Contributors:

Blairon, Laurent
Wilmet, Alain
Beukinga, Ingrid
Tré-Hardy, Marie

Links:

Volltext

Keywords:

Antigen testing
COVID-19
Comment
Journal Article
Point-of-care
QRT-PCR
Rapid diagnosis
SARS-CoV-2

Notes:

Date Completed 04.08.2020

Date Revised 10.01.2021

published: Print-Electronic

CommentOn: Front Med (Lausanne). 2020 May 08;7:225. - PMID 32574326

Citation Status PubMed-not-MEDLINE

Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Physical Description:

Online-Ressource

doi:

10.1016/j.jcv.2020.104472

PMID:

32504944

PPN (Catalogue-ID):

NLM311739709