A SARS-CoV-2 coronavirus nucleocapsid protein antigen-detecting lateral flow assay
Inexpensive, simple, rapid diagnostics are necessary for efficient detection, treatment, and mitigation of COVID-19. Assays for SARS-CoV2 using reverse transcription polymerase chain reaction (RT-PCR) offer good sensitivity and excellent specificity, but are expensive, slowed by transport to central...
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| Veröffentlicht in: | PloS one 2021-11, Vol.16 (11), p.e0258819-e0258819 |
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| creator | Grant, Benjamin D Anderson, Caitlin E Alonzo, Luis F Garing, Spencer H Williford, John R Baughman, Ted A Rivera, Rafael Glukhova, Veronika A Boyle, David S Dewan, Puneet K Weigl, Bernhard H Nichols, Kevin P |
| description | Inexpensive, simple, rapid diagnostics are necessary for efficient detection, treatment, and mitigation of COVID-19. Assays for SARS-CoV2 using reverse transcription polymerase chain reaction (RT-PCR) offer good sensitivity and excellent specificity, but are expensive, slowed by transport to centralized testing laboratories, and often unavailable. Antigen-based assays are inexpensive and can be rapidly mass-produced and deployed at point-of-care, with lateral flow assays (LFAs) being the most common format. While various manufacturers have produced commercially available SARS-Cov2 antigen LFAs, access to validated tests remains difficult or cost prohibitive in low-and middle-income countries. Herein, we present a visually read open-access LFA (OA-LFA) using commercially-available antibodies and materials for the detection of SARS-CoV-2. The LFA yielded a Limit of Detection (LOD) of 4 TCID.sub.50 /swab of gamma irradiated SARS-CoV-2 virus, meeting the acceptable analytical sensitivity outlined by in World Health Organization target product profile. The open-source architecture presented in this manuscript provides a template for manufacturers around the globe to rapidly design a SARS-CoV2 antigen test. |
| doi_str_mv | 10.1371/journal.pone.0258819 |
| format | Article |
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Assays for SARS-CoV2 using reverse transcription polymerase chain reaction (RT-PCR) offer good sensitivity and excellent specificity, but are expensive, slowed by transport to centralized testing laboratories, and often unavailable. Antigen-based assays are inexpensive and can be rapidly mass-produced and deployed at point-of-care, with lateral flow assays (LFAs) being the most common format. While various manufacturers have produced commercially available SARS-Cov2 antigen LFAs, access to validated tests remains difficult or cost prohibitive in low-and middle-income countries. Herein, we present a visually read open-access LFA (OA-LFA) using commercially-available antibodies and materials for the detection of SARS-CoV-2. The LFA yielded a Limit of Detection (LOD) of 4 TCID.sub.50 /swab of gamma irradiated SARS-CoV-2 virus, meeting the acceptable analytical sensitivity outlined by in World Health Organization target product profile. The open-source architecture presented in this manuscript provides a template for manufacturers around the globe to rapidly design a SARS-CoV2 antigen test.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0258819</identifier><identifier>PMID: 34758052</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Analysis ; Antibodies ; Antigens ; Assaying ; Biology and life sciences ; Coronaviruses ; COVID-19 ; Disease transmission ; Medicine and Health Sciences ; Mitigation ; Nucleocapsids ; Pandemics ; Physical Sciences ; Polymerase chain reaction ; Research and Analysis Methods ; Reverse transcription ; Sensitivity analysis ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Supervision ; User training ; Viral diseases ; Viruses</subject><ispartof>PloS one, 2021-11, Vol.16 (11), p.e0258819-e0258819</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Grant et al. 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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Analysis Antibodies Antigens Assaying Biology and life sciences Coronaviruses COVID-19 Disease transmission Medicine and Health Sciences Mitigation Nucleocapsids Pandemics Physical Sciences Polymerase chain reaction Research and Analysis Methods Reverse transcription Sensitivity analysis Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Supervision User training Viral diseases Viruses |
| title | A SARS-CoV-2 coronavirus nucleocapsid protein antigen-detecting lateral flow assay |
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