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Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection
Introduction Accurate point-of-care testing for SARS-CoV-2 could quickly identify which patients need to be isolated and improve flow for patients being admitted as an emergency to the hospital. We evaluated two diagnostic tests with shorter turnaround times, the Siemens Clinitest Lateral Flow (Siem...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cureus
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8553283/ https://www.ncbi.nlm.nih.gov/pubmed/34725589 http://dx.doi.org/10.7759/cureus.18319 |
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author | Boyle, Adrian A Hardwick, Susie Warne, Ben Nwuba, Chukwuneyem Kosisochukwu Brown, Nicholas Shaw, Ashley |
author_facet | Boyle, Adrian A Hardwick, Susie Warne, Ben Nwuba, Chukwuneyem Kosisochukwu Brown, Nicholas Shaw, Ashley |
author_sort | Boyle, Adrian A |
collection | PubMed |
description | Introduction Accurate point-of-care testing for SARS-CoV-2 could quickly identify which patients need to be isolated and improve flow for patients being admitted as an emergency to the hospital. We evaluated two diagnostic tests with shorter turnaround times, the Siemens Clinitest Lateral Flow (Siemens Healthineers AG, Erlangen, Germany) and the Simple AMplification-Based Assay (SAMBA)-2 PCR test against a standard laboratory PCR test. Methods We conducted a prospective diagnostic cohort study in a single English emergency department. Adult participants underwent three swabs: the Siemens Clinitest Lateral Flow Test, the SAMBA-2 and a standard laboratory PCR test. Results A total of 212 participants were recruited. The sensitivity and specificity of the Siemens Clinitest Lateral Flow Test against the laboratory PCR test was 55.6% (95% CI 30.8-78.5) and 100% (95% CI 98.1-100) respectively. The sensitivity and specificity of the SAMBA-2 PCR test against the laboratory PCR test was 60.0% (95% CI 32.3-83.7) and 100% (95% CI 97.9-100) respectively. Conclusion Neither the Siemens Clinitest Lateral Flow Test nor the SAMBA-2 PCR test demonstrated sufficient sensitivity to rule out active SARS-CoV-2 infection. Both tests demonstrated high specificity. |
format | Online Article Text |
id | pubmed-8553283 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Cureus |
record_format | MEDLINE/PubMed |
spelling | pubmed-85532832021-10-31 Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection Boyle, Adrian A Hardwick, Susie Warne, Ben Nwuba, Chukwuneyem Kosisochukwu Brown, Nicholas Shaw, Ashley Cureus Emergency Medicine Introduction Accurate point-of-care testing for SARS-CoV-2 could quickly identify which patients need to be isolated and improve flow for patients being admitted as an emergency to the hospital. We evaluated two diagnostic tests with shorter turnaround times, the Siemens Clinitest Lateral Flow (Siemens Healthineers AG, Erlangen, Germany) and the Simple AMplification-Based Assay (SAMBA)-2 PCR test against a standard laboratory PCR test. Methods We conducted a prospective diagnostic cohort study in a single English emergency department. Adult participants underwent three swabs: the Siemens Clinitest Lateral Flow Test, the SAMBA-2 and a standard laboratory PCR test. Results A total of 212 participants were recruited. The sensitivity and specificity of the Siemens Clinitest Lateral Flow Test against the laboratory PCR test was 55.6% (95% CI 30.8-78.5) and 100% (95% CI 98.1-100) respectively. The sensitivity and specificity of the SAMBA-2 PCR test against the laboratory PCR test was 60.0% (95% CI 32.3-83.7) and 100% (95% CI 97.9-100) respectively. Conclusion Neither the Siemens Clinitest Lateral Flow Test nor the SAMBA-2 PCR test demonstrated sufficient sensitivity to rule out active SARS-CoV-2 infection. Both tests demonstrated high specificity. Cureus 2021-09-27 /pmc/articles/PMC8553283/ /pubmed/34725589 http://dx.doi.org/10.7759/cureus.18319 Text en Copyright © 2021, Boyle et al. https://creativecommons.org/licenses/by/3.0/This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Emergency Medicine Boyle, Adrian A Hardwick, Susie Warne, Ben Nwuba, Chukwuneyem Kosisochukwu Brown, Nicholas Shaw, Ashley Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection |
title | Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection |
title_full | Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection |
title_fullStr | Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection |
title_full_unstemmed | Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection |
title_short | Evaluating the Sensitivity and Specificity of Siemens Clinitest Lateral Flow Test and the Simple AMplification-Based Assay (SAMBA)-2 PCR Test for SARS-CoV-2 Infection |
title_sort | evaluating the sensitivity and specificity of siemens clinitest lateral flow test and the simple amplification-based assay (samba)-2 pcr test for sars-cov-2 infection |
topic | Emergency Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8553283/ https://www.ncbi.nlm.nih.gov/pubmed/34725589 http://dx.doi.org/10.7759/cureus.18319 |
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