Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
•The ID NOW COVID-19 assay is a rapid molecular biology test based on nicking endonuclease amplification reaction (NEAR) evaluated prospectively in the emergency department.•Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded good performance.•When the ID NOW COVID-19 test wa...
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| Veröffentlicht in: | Journal of clinical virology 2021-12, Vol.145, p.105021-105021, Article 105021 |
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| container_title | Journal of clinical virology |
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| creator | NguyenVan, Jean-Claude Gerlier, Camille Pilmis, Benoît Mizrahi, Assaf Péan de Ponfilly, Gauthier Khaterchi, Amir Enouf, Vincent Ganansia, Olivier Le Monnier, Alban |
| description | •The ID NOW COVID-19 assay is a rapid molecular biology test based on nicking endonuclease amplification reaction (NEAR) evaluated prospectively in the emergency department.•Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded good performance.•When the ID NOW COVID-19 test was performed in the laboratory using the VTM samples, the sensitivity decreased significantly.•ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods.
Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR).
The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED).
This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory.
Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30).
We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods |
| doi_str_mv | 10.1016/j.jcv.2021.105021 |
| format | Article |
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Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR).
The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED).
This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory.
Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30).
We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2021.105021</identifier><identifier>PMID: 34768231</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>COVID-19 ; COVID-19 Testing ; Emergency department ; Emergency Service, Hospital ; Humans ; ID NOW COVID-19 ; Isothermal amplification ; Life Sciences ; Microbiology and Parasitology ; Nasopharynx ; Point-of-care test ; Point-of-Care Testing ; Prospective Studies ; SARS-CoV-2 ; Sensitivity and Specificity</subject><ispartof>Journal of clinical virology, 2021-12, Vol.145, p.105021-105021, Article 105021</ispartof><rights>2021 Elsevier B.V.</rights><rights>Copyright © 2021 Elsevier B.V. All rights reserved.</rights><rights>Copyright</rights><rights>2021 Elsevier B.V. All rights reserved. 2021 Elsevier B.V.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c485t-4dd802a39320db2576da9598114367b8d7cef3d411217e9ec99538be67c7753e3</citedby><cites>FETCH-LOGICAL-c485t-4dd802a39320db2576da9598114367b8d7cef3d411217e9ec99538be67c7753e3</cites><orcidid>0000-0001-7432-1657 ; 0000-0001-6181-281X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1386653221002882$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34768231$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04096891$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>NguyenVan, Jean-Claude</creatorcontrib><creatorcontrib>Gerlier, Camille</creatorcontrib><creatorcontrib>Pilmis, Benoît</creatorcontrib><creatorcontrib>Mizrahi, Assaf</creatorcontrib><creatorcontrib>Péan de Ponfilly, Gauthier</creatorcontrib><creatorcontrib>Khaterchi, Amir</creatorcontrib><creatorcontrib>Enouf, Vincent</creatorcontrib><creatorcontrib>Ganansia, Olivier</creatorcontrib><creatorcontrib>Le Monnier, Alban</creatorcontrib><title>Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>•The ID NOW COVID-19 assay is a rapid molecular biology test based on nicking endonuclease amplification reaction (NEAR) evaluated prospectively in the emergency department.•Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded good performance.•When the ID NOW COVID-19 test was performed in the laboratory using the VTM samples, the sensitivity decreased significantly.•ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods.
Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR).
The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED).
This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory.
Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30).
We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods</description><subject>COVID-19</subject><subject>COVID-19 Testing</subject><subject>Emergency department</subject><subject>Emergency Service, Hospital</subject><subject>Humans</subject><subject>ID NOW COVID-19</subject><subject>Isothermal amplification</subject><subject>Life Sciences</subject><subject>Microbiology and Parasitology</subject><subject>Nasopharynx</subject><subject>Point-of-care test</subject><subject>Point-of-Care Testing</subject><subject>Prospective Studies</subject><subject>SARS-CoV-2</subject><subject>Sensitivity and Specificity</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UcuKFDEULURxHvoBbiRLXVSbR-WFIAw9jtPQ2C58LEM6uTWTpl4mVQX996apcVAXbnLvTc45l5xTFK8IXhFMxLvD6uDmFcWU5Jnn8qQ4J0qykmshn-aeKVEKzuhZcZHSAWPCWSWfF2f5FIoycl7Al9inAdwYZkAw22ayY-g71Ndoc40-736g9e775rokGtmU7BFNCXxu0dCHbiz7unQ2AhohjSh0yHYIWoh30Lkj8jDYOLbQjS-KZ7VtErx8qJfFt5uPX9e35Xb3abO-2pauUnwsK-8VppZpRrHfUy6Ft5prRUjFhNwrLx3UzFeEUCJBg9OaM7UHIZ2UnAG7LD4susO0b8G7vDraxgwxtDYeTW-D-fulC_fmrp-N4lxgUWWBt4vA_T-026utOd3hCmuhNJlJxr55WBb7n1M2wLQhOWga20E_JUO5lpWqJFUZShaoy26nCPWjNsHmFKU5mBylOUVpligz5_Wff3lk_M4uA94vAMiOzgGiSS5k48GHmAM1vg__kf8FL8SteQ</recordid><startdate>20211201</startdate><enddate>20211201</enddate><creator>NguyenVan, Jean-Claude</creator><creator>Gerlier, Camille</creator><creator>Pilmis, Benoît</creator><creator>Mizrahi, Assaf</creator><creator>Péan de Ponfilly, Gauthier</creator><creator>Khaterchi, Amir</creator><creator>Enouf, Vincent</creator><creator>Ganansia, Olivier</creator><creator>Le Monnier, Alban</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7432-1657</orcidid><orcidid>https://orcid.org/0000-0001-6181-281X</orcidid></search><sort><creationdate>20211201</creationdate><title>Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department</title><author>NguyenVan, Jean-Claude ; 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Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR).
The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED).
This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory.
Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30).
We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>34768231</pmid><doi>10.1016/j.jcv.2021.105021</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-7432-1657</orcidid><orcidid>https://orcid.org/0000-0001-6181-281X</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | COVID-19 COVID-19 Testing Emergency department Emergency Service, Hospital Humans ID NOW COVID-19 Isothermal amplification Life Sciences Microbiology and Parasitology Nasopharynx Point-of-care test Point-of-Care Testing Prospective Studies SARS-CoV-2 Sensitivity and Specificity |
| title | Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department |
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