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 |
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| Media Type: |
Electronic Article |
| Year of Publication: |
2020 |
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| Contained In: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - Vol. 129 (2020), p. 104472 |
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| Language: |
English |
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| Contributors: |
Blairon, Laurent |
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| Links: |
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| Keywords: |
Antigen testing |
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| 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 |
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| Physical Description: |
Online-Ressource |
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| doi: |
10.1016/j.jcv.2020.104472 |
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| PMID: |
32504944 |
| PPN (Catalogue-ID): |
NLM311739709 |
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| 500 | |a Date Revised 10.01.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentOn: Front Med (Lausanne). 2020 May 08;7:225. - PMID 32574326 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 500 | |a Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine | ||
| 520 | |a Copyright © 2020 Elsevier B.V. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
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