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Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays
Several real-time RT-PCR assays have received Emergency Use Authorization from the United States Food and Drug Administration. The BD MAX™ SARS-CoV-2 assay, run by the BD MAX™ system, is a qualitative test that detects the SARS-CoV-2 specific nucleocapsid phosphoprotein gene regions, N1 and N2. The...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Biomedical
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7987987/ https://www.ncbi.nlm.nih.gov/pubmed/33571862 http://dx.doi.org/10.1016/j.diagmicrobio.2021.115334 |
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author | Navarathna, Dhammika H. Sharp, Shawn Lukey, Janell Arenas, Monica Villas, Horace Wiley, Linda Englett, Ivy Juan, Ma Rowena San Jinadatha, Chetan |
author_facet | Navarathna, Dhammika H. Sharp, Shawn Lukey, Janell Arenas, Monica Villas, Horace Wiley, Linda Englett, Ivy Juan, Ma Rowena San Jinadatha, Chetan |
author_sort | Navarathna, Dhammika H. |
collection | PubMed |
description | Several real-time RT-PCR assays have received Emergency Use Authorization from the United States Food and Drug Administration. The BD MAX™ SARS-CoV-2 assay, run by the BD MAX™ system, is a qualitative test that detects the SARS-CoV-2 specific nucleocapsid phosphoprotein gene regions, N1 and N2. The human RNase P gene is used as the endogenous nucleic acid extraction control. The Cepheid Xpert® Xpress SARS-CoV-2 assay, run by the GeneXpert system, detects the pan-sarbecovirus E gene and the N2 region of the N gene. We evaluated the performance characteristics of the BD and Cepheid assays using matched patient samples. We also analyzed comparative Ct values for both assays using 183 positive samples tested at this facility. In addition, we mitigated reporting false positive results without relying on interpretive software. We found that both systems showed comparable sensitivity. We found an approximately 3.5% false positive rate from the BD MAX™ system results. |
format | Online Article Text |
id | pubmed-7987987 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier Biomedical |
record_format | MEDLINE/PubMed |
spelling | pubmed-79879872021-03-24 Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays Navarathna, Dhammika H. Sharp, Shawn Lukey, Janell Arenas, Monica Villas, Horace Wiley, Linda Englett, Ivy Juan, Ma Rowena San Jinadatha, Chetan Diagn Microbiol Infect Dis Article Several real-time RT-PCR assays have received Emergency Use Authorization from the United States Food and Drug Administration. The BD MAX™ SARS-CoV-2 assay, run by the BD MAX™ system, is a qualitative test that detects the SARS-CoV-2 specific nucleocapsid phosphoprotein gene regions, N1 and N2. The human RNase P gene is used as the endogenous nucleic acid extraction control. The Cepheid Xpert® Xpress SARS-CoV-2 assay, run by the GeneXpert system, detects the pan-sarbecovirus E gene and the N2 region of the N gene. We evaluated the performance characteristics of the BD and Cepheid assays using matched patient samples. We also analyzed comparative Ct values for both assays using 183 positive samples tested at this facility. In addition, we mitigated reporting false positive results without relying on interpretive software. We found that both systems showed comparable sensitivity. We found an approximately 3.5% false positive rate from the BD MAX™ system results. Elsevier Biomedical 2021-05 2021-02-02 /pmc/articles/PMC7987987/ /pubmed/33571862 http://dx.doi.org/10.1016/j.diagmicrobio.2021.115334 Text en Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Navarathna, Dhammika H. Sharp, Shawn Lukey, Janell Arenas, Monica Villas, Horace Wiley, Linda Englett, Ivy Juan, Ma Rowena San Jinadatha, Chetan Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays |
title | Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays |
title_full | Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays |
title_fullStr | Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays |
title_full_unstemmed | Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays |
title_short | Understanding false positives and the detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and BD MAX SARS-CoV-2 assays |
title_sort | understanding false positives and the detection of sars-cov-2 using the cepheid xpert xpress sars-cov-2 and bd max sars-cov-2 assays |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7987987/ https://www.ncbi.nlm.nih.gov/pubmed/33571862 http://dx.doi.org/10.1016/j.diagmicrobio.2021.115334 |
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