tetano
Editor, Senior Moderator
PLoS One
. 2021 Nov 10;16(11):e0258819.
doi: 10.1371/journal.pone.0258819. eCollection 2021.
A SARS-CoV-2 coronavirus nucleocapsid protein antigen-detecting lateral flow assay
Benjamin D Grant[SUP] 1 [/SUP], Caitlin E Anderson[SUP] 1 [/SUP], Luis F Alonzo[SUP] 1 [/SUP], Spencer H Garing[SUP] 1 [/SUP], John R Williford[SUP] 2 [/SUP], Ted A Baughman[SUP] 1 [/SUP], Rafael Rivera[SUP] 1 [/SUP], Veronika A Glukhova[SUP] 1 [/SUP], David S Boyle[SUP] 3 [/SUP], Puneet K Dewan[SUP] 1 [/SUP], Bernhard H Weigl[SUP] 1 [/SUP], Kevin P Nichols[SUP] 1 [/SUP]
Affiliations
Abstract
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 TCID50/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.
. 2021 Nov 10;16(11):e0258819.
doi: 10.1371/journal.pone.0258819. eCollection 2021.
A SARS-CoV-2 coronavirus nucleocapsid protein antigen-detecting lateral flow assay
Benjamin D Grant[SUP] 1 [/SUP], Caitlin E Anderson[SUP] 1 [/SUP], Luis F Alonzo[SUP] 1 [/SUP], Spencer H Garing[SUP] 1 [/SUP], John R Williford[SUP] 2 [/SUP], Ted A Baughman[SUP] 1 [/SUP], Rafael Rivera[SUP] 1 [/SUP], Veronika A Glukhova[SUP] 1 [/SUP], David S Boyle[SUP] 3 [/SUP], Puneet K Dewan[SUP] 1 [/SUP], Bernhard H Weigl[SUP] 1 [/SUP], Kevin P Nichols[SUP] 1 [/SUP]
Affiliations
- PMID: 34758052
- DOI: 10.1371/journal.pone.0258819
Abstract
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 TCID50/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.