Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients
Introduction Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID‐19‐positive subjects. The aim of this study was to compare the pe...
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creator | Petruzziello, Arnolfo Sabatino, Rocco Catapane, Livia Anna De Falco, Carmela Petti, Antonella Tripaldelli, Elena Loquercio, Giovanna Annecchiarico, Angela Salzillo, Angela Caradonna, Eugenio Maggi, Paolo |
description | Introduction
Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID‐19‐positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real‐time RT‐PCR, the gold standard for the diagnosis of SARS‐CoV‐2 infection, in a strictly selected asymptomatic population.
Materials and Methods
A total of 392 consecutive oro‐nasopharyngeal swabs were collected from patients with no symptoms related to COVID‐19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS‐CoV‐2 antigen compared to qualitative real‐time RT‐PCR in asymptomatic patients.
Results
Lumipulse® SARS‐CoV‐2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (Ct)‐value reaching 100% and 86% with 15 |
doi_str_mv | 10.1002/jcla.24867 |
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Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID‐19‐positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real‐time RT‐PCR, the gold standard for the diagnosis of SARS‐CoV‐2 infection, in a strictly selected asymptomatic population.
Materials and Methods
A total of 392 consecutive oro‐nasopharyngeal swabs were collected from patients with no symptoms related to COVID‐19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS‐CoV‐2 antigen compared to qualitative real‐time RT‐PCR in asymptomatic patients.
Results
Lumipulse® SARS‐CoV‐2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (Ct)‐value reaching 100% and 86% with 15 < Ct < 25 and Ct ≥ 25, respectively. The ROC analysis yielded an AUC value of 0.98, suggesting that the antigen test may accurately detect SARS‐CoV‐2.
Conclusion
Our data showed that Lumipulse® SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission in large asymptomatic populations.
The study evaluates the performance of the Lumipulse® SARS‐CoV‐2 antigen assay able to detect SARS‐CoV‐2 nucleocapsid antigen in oro‐nasopharyngeal swab samples by comparing it with qualitative real‐time RT‐PCR. The data obtained show that SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission.</description><identifier>ISSN: 0887-8013</identifier><identifier>EISSN: 1098-2825</identifier><identifier>DOI: 10.1002/jcla.24867</identifier><identifier>PMID: 36972465</identifier><language>eng</language><publisher>United States: John Wiley & Sons, Inc</publisher><subject>Age ; Antigens ; Asymptomatic ; Automation ; comparison ; Coronaviruses ; COVID-19 ; COVID-19 - diagnosis ; COVID-19 - epidemiology ; Emergency medical care ; Emergency Service, Hospital ; Enzymes ; Females ; Humans ; Immunoassay ; Immunologic Tests ; Infections ; Monoclonal antibodies ; Pandemics ; Patients ; Performance evaluation ; Polymerase chain reaction ; Public health ; ROC Curve ; RT‐PCR ; SARS-CoV-2 - genetics ; SARS‐CoV‐2 antigen ; Sensitivity and Specificity ; Severe acute respiratory syndrome coronavirus 2</subject><ispartof>Journal of clinical laboratory analysis, 2023-03, Vol.37 (6), p.e24867-n/a</ispartof><rights>2023 The Authors. published by Wiley Periodicals LLC.</rights><rights>2023 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.</rights><rights>2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4497-80a4b660b3f22980ab7265cf3118744534c5961af13b75b351ff854fa5eab4923</citedby><cites>FETCH-LOGICAL-c4497-80a4b660b3f22980ab7265cf3118744534c5961af13b75b351ff854fa5eab4923</cites><orcidid>0000-0003-0353-9151</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10156099/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10156099/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1411,11542,27903,27904,45553,45554,46030,46454,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36972465$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Petruzziello, Arnolfo</creatorcontrib><creatorcontrib>Sabatino, Rocco</creatorcontrib><creatorcontrib>Catapane, Livia Anna</creatorcontrib><creatorcontrib>De Falco, Carmela</creatorcontrib><creatorcontrib>Petti, Antonella</creatorcontrib><creatorcontrib>Tripaldelli, Elena</creatorcontrib><creatorcontrib>Loquercio, Giovanna</creatorcontrib><creatorcontrib>Annecchiarico, Angela</creatorcontrib><creatorcontrib>Salzillo, Angela</creatorcontrib><creatorcontrib>Caradonna, Eugenio</creatorcontrib><creatorcontrib>Maggi, Paolo</creatorcontrib><title>Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients</title><title>Journal of clinical laboratory analysis</title><addtitle>J Clin Lab Anal</addtitle><description>Introduction
Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID‐19‐positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real‐time RT‐PCR, the gold standard for the diagnosis of SARS‐CoV‐2 infection, in a strictly selected asymptomatic population.
Materials and Methods
A total of 392 consecutive oro‐nasopharyngeal swabs were collected from patients with no symptoms related to COVID‐19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS‐CoV‐2 antigen compared to qualitative real‐time RT‐PCR in asymptomatic patients.
Results
Lumipulse® SARS‐CoV‐2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (Ct)‐value reaching 100% and 86% with 15 < Ct < 25 and Ct ≥ 25, respectively. The ROC analysis yielded an AUC value of 0.98, suggesting that the antigen test may accurately detect SARS‐CoV‐2.
Conclusion
Our data showed that Lumipulse® SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission in large asymptomatic populations.
The study evaluates the performance of the Lumipulse® SARS‐CoV‐2 antigen assay able to detect SARS‐CoV‐2 nucleocapsid antigen in oro‐nasopharyngeal swab samples by comparing it with qualitative real‐time RT‐PCR. The data obtained show that SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission.</description><subject>Age</subject><subject>Antigens</subject><subject>Asymptomatic</subject><subject>Automation</subject><subject>comparison</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - diagnosis</subject><subject>COVID-19 - epidemiology</subject><subject>Emergency medical care</subject><subject>Emergency Service, Hospital</subject><subject>Enzymes</subject><subject>Females</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Immunologic Tests</subject><subject>Infections</subject><subject>Monoclonal antibodies</subject><subject>Pandemics</subject><subject>Patients</subject><subject>Performance evaluation</subject><subject>Polymerase chain reaction</subject><subject>Public health</subject><subject>ROC Curve</subject><subject>RT‐PCR</subject><subject>SARS-CoV-2 - genetics</subject><subject>SARS‐CoV‐2 antigen</subject><subject>Sensitivity and Specificity</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><issn>0887-8013</issn><issn>1098-2825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kc9qFDEcx4NY7Fq9-AAS8CKFrfk_yUmWxVploWDVa8jEpGbJTMZkpjI3H8En8SF8FJ-k2W4t6sHLLyT58MmXfAF4gtEJRoi82NpoTgiTorkHFhgpuSSS8PtggaRslhJheggelrJFCEmFxQNwSIVqCBN8Abar3sR5DNZEOLjsU-5Mbx10VyZOZgyph8nDzdSFYYrF_fwBL1bvLn59-75OH-sk0PRjuHQ9NKWYGYYeUlUPy9wNY-qqwMKhTteP5RE48KY6Ht-uR-DD6av367Pl5vz1m_Vqs7SMqV1ew1ohUEs9Iaru2oYIbj3FWDaMccosVwIbj2nb8JZy7L3kzBvuTMsUoUfg5d47TG3nPtn6djZRDzl0Js86maD_vunDZ32ZrjRGmAukVDU8vzXk9GVyZdRdKNbFaHqXpqKJRIqzhmBc0Wf_oNs05fqnN5QUTHEpK3W8p2xOpWTn79JgpHcd6l2H-qbDCj_9M_8d-ru0CuA98DVEN_9Hpd-uN6u99BpVyamP</recordid><startdate>202303</startdate><enddate>202303</enddate><creator>Petruzziello, Arnolfo</creator><creator>Sabatino, Rocco</creator><creator>Catapane, Livia Anna</creator><creator>De Falco, Carmela</creator><creator>Petti, Antonella</creator><creator>Tripaldelli, Elena</creator><creator>Loquercio, Giovanna</creator><creator>Annecchiarico, Angela</creator><creator>Salzillo, Angela</creator><creator>Caradonna, Eugenio</creator><creator>Maggi, Paolo</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><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>3V.</scope><scope>7QP</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>COVID</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M7P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-0353-9151</orcidid></search><sort><creationdate>202303</creationdate><title>Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients</title><author>Petruzziello, Arnolfo ; Sabatino, Rocco ; Catapane, Livia Anna ; De Falco, Carmela ; Petti, Antonella ; Tripaldelli, Elena ; Loquercio, Giovanna ; Annecchiarico, Angela ; Salzillo, Angela ; Caradonna, Eugenio ; Maggi, Paolo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4497-80a4b660b3f22980ab7265cf3118744534c5961af13b75b351ff854fa5eab4923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Age</topic><topic>Antigens</topic><topic>Asymptomatic</topic><topic>Automation</topic><topic>comparison</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 - diagnosis</topic><topic>COVID-19 - epidemiology</topic><topic>Emergency medical care</topic><topic>Emergency Service, Hospital</topic><topic>Enzymes</topic><topic>Females</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Immunologic Tests</topic><topic>Infections</topic><topic>Monoclonal antibodies</topic><topic>Pandemics</topic><topic>Patients</topic><topic>Performance evaluation</topic><topic>Polymerase chain reaction</topic><topic>Public health</topic><topic>ROC Curve</topic><topic>RT‐PCR</topic><topic>SARS-CoV-2 - genetics</topic><topic>SARS‐CoV‐2 antigen</topic><topic>Sensitivity and Specificity</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Petruzziello, Arnolfo</creatorcontrib><creatorcontrib>Sabatino, Rocco</creatorcontrib><creatorcontrib>Catapane, Livia Anna</creatorcontrib><creatorcontrib>De Falco, Carmela</creatorcontrib><creatorcontrib>Petti, Antonella</creatorcontrib><creatorcontrib>Tripaldelli, Elena</creatorcontrib><creatorcontrib>Loquercio, Giovanna</creatorcontrib><creatorcontrib>Annecchiarico, Angela</creatorcontrib><creatorcontrib>Salzillo, Angela</creatorcontrib><creatorcontrib>Caradonna, Eugenio</creatorcontrib><creatorcontrib>Maggi, Paolo</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Biological Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical laboratory analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Petruzziello, Arnolfo</au><au>Sabatino, Rocco</au><au>Catapane, Livia Anna</au><au>De Falco, Carmela</au><au>Petti, Antonella</au><au>Tripaldelli, Elena</au><au>Loquercio, Giovanna</au><au>Annecchiarico, Angela</au><au>Salzillo, Angela</au><au>Caradonna, Eugenio</au><au>Maggi, Paolo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients</atitle><jtitle>Journal of clinical laboratory analysis</jtitle><addtitle>J Clin Lab Anal</addtitle><date>2023-03</date><risdate>2023</risdate><volume>37</volume><issue>6</issue><spage>e24867</spage><epage>n/a</epage><pages>e24867-n/a</pages><issn>0887-8013</issn><eissn>1098-2825</eissn><abstract>Introduction
Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID‐19‐positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real‐time RT‐PCR, the gold standard for the diagnosis of SARS‐CoV‐2 infection, in a strictly selected asymptomatic population.
Materials and Methods
A total of 392 consecutive oro‐nasopharyngeal swabs were collected from patients with no symptoms related to COVID‐19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS‐CoV‐2 antigen compared to qualitative real‐time RT‐PCR in asymptomatic patients.
Results
Lumipulse® SARS‐CoV‐2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (Ct)‐value reaching 100% and 86% with 15 < Ct < 25 and Ct ≥ 25, respectively. The ROC analysis yielded an AUC value of 0.98, suggesting that the antigen test may accurately detect SARS‐CoV‐2.
Conclusion
Our data showed that Lumipulse® SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission in large asymptomatic populations.
The study evaluates the performance of the Lumipulse® SARS‐CoV‐2 antigen assay able to detect SARS‐CoV‐2 nucleocapsid antigen in oro‐nasopharyngeal swab samples by comparing it with qualitative real‐time RT‐PCR. The data obtained show that SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission.</abstract><cop>United States</cop><pub>John Wiley & Sons, Inc</pub><pmid>36972465</pmid><doi>10.1002/jcla.24867</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-0353-9151</orcidid><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; DOAJ Directory of Open Access Journals; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley Online Library Open Access; PubMed Central |
subjects | Age Antigens Asymptomatic Automation comparison Coronaviruses COVID-19 COVID-19 - diagnosis COVID-19 - epidemiology Emergency medical care Emergency Service, Hospital Enzymes Females Humans Immunoassay Immunologic Tests Infections Monoclonal antibodies Pandemics Patients Performance evaluation Polymerase chain reaction Public health ROC Curve RT‐PCR SARS-CoV-2 - genetics SARS‐CoV‐2 antigen Sensitivity and Specificity Severe acute respiratory syndrome coronavirus 2 |
title | Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients |
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