Cargando…

Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration

BACKGROUND: This study was planned to investigate how the positivization time of a SARS-CoV-2 rapid antigen self-test may correlate with SARS-CoV-2 nucleocapsid (N) antigen concentration measured with a quantitative laboratory-based immunoassay. METHODS: Paired nasopharyngeal (healthcare-collected)...

Descripción completa

Detalles Bibliográficos
Autores principales: Salvagno, Gian Luca, Henry, Brandon M., De Nitto, Simone, Pighi, Laura, Lippi, Giuseppe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Communications and Publications Division (CPD) of the IFCC 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9768622/
https://www.ncbi.nlm.nih.gov/pubmed/36605302
_version_ 1784854211917250560
author Salvagno, Gian Luca
Henry, Brandon M.
De Nitto, Simone
Pighi, Laura
Lippi, Giuseppe
author_facet Salvagno, Gian Luca
Henry, Brandon M.
De Nitto, Simone
Pighi, Laura
Lippi, Giuseppe
author_sort Salvagno, Gian Luca
collection PubMed
description BACKGROUND: This study was planned to investigate how the positivization time of a SARS-CoV-2 rapid antigen self-test may correlate with SARS-CoV-2 nucleocapsid (N) antigen concentration measured with a quantitative laboratory-based immunoassay. METHODS: Paired nasopharyngeal (healthcare-collected) and nasal (self-collected) samples were taken from patients undergoing routine SARS-CoV-2 testing. The concentration of SARS-CoV-2 antigen nucleocapsid (N) was assayed with Liaison SARS-CoV-2 Antigen test, whilst the time of positivization of COVID-VIRO ALL rapid diagnostic test (RDT) was concomitantly measured and then compared SARS-CoV-2 viral load measured with Liaison SARS-CoV-2 Antigen test and expressed as Median Tissue Culture Infectious Dose (TCID50)/mL. RESULTS: The study sample consisted of 32 paired specimens which tested positive with COVID-VIRO ALL IN RDT and had SARS-CoV-2 N protein concentration measured with Liaison SARS-CoV-2 Antigen test. A highly significant correlation was found between SARS-CoV-2 viral antigen concentration and RDT positivization time (r=-0.64; 95%CI, -0.81 to -0.38; p<0.001). At the >1500 TCID50/mL threshold of the Liaison SARS-CoV-2 Antigen test, the positivization time of the COVID-VIRO ALL IN RDT displayed high accuracy (93.7%). A positivization time <42 sec enabled to identify patients with high SARS-CoV-2 antigen concentration (i.e., >1500 TCID50/mL) with 91.3% negative and 100% positive predictive values. CONCLUSION: Self-testing using COVID-VIRO ALL IN RDT could be reliably used for garnering valuable information on the actual SARS-CoV-2 viral antigen concentration in respiratory samples.
format Online
Article
Text
id pubmed-9768622
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher The Communications and Publications Division (CPD) of the IFCC
record_format MEDLINE/PubMed
spelling pubmed-97686222023-01-04 Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration Salvagno, Gian Luca Henry, Brandon M. De Nitto, Simone Pighi, Laura Lippi, Giuseppe EJIFCC Research Article BACKGROUND: This study was planned to investigate how the positivization time of a SARS-CoV-2 rapid antigen self-test may correlate with SARS-CoV-2 nucleocapsid (N) antigen concentration measured with a quantitative laboratory-based immunoassay. METHODS: Paired nasopharyngeal (healthcare-collected) and nasal (self-collected) samples were taken from patients undergoing routine SARS-CoV-2 testing. The concentration of SARS-CoV-2 antigen nucleocapsid (N) was assayed with Liaison SARS-CoV-2 Antigen test, whilst the time of positivization of COVID-VIRO ALL rapid diagnostic test (RDT) was concomitantly measured and then compared SARS-CoV-2 viral load measured with Liaison SARS-CoV-2 Antigen test and expressed as Median Tissue Culture Infectious Dose (TCID50)/mL. RESULTS: The study sample consisted of 32 paired specimens which tested positive with COVID-VIRO ALL IN RDT and had SARS-CoV-2 N protein concentration measured with Liaison SARS-CoV-2 Antigen test. A highly significant correlation was found between SARS-CoV-2 viral antigen concentration and RDT positivization time (r=-0.64; 95%CI, -0.81 to -0.38; p<0.001). At the >1500 TCID50/mL threshold of the Liaison SARS-CoV-2 Antigen test, the positivization time of the COVID-VIRO ALL IN RDT displayed high accuracy (93.7%). A positivization time <42 sec enabled to identify patients with high SARS-CoV-2 antigen concentration (i.e., >1500 TCID50/mL) with 91.3% negative and 100% positive predictive values. CONCLUSION: Self-testing using COVID-VIRO ALL IN RDT could be reliably used for garnering valuable information on the actual SARS-CoV-2 viral antigen concentration in respiratory samples. The Communications and Publications Division (CPD) of the IFCC 2022-12-12 /pmc/articles/PMC9768622/ /pubmed/36605302 Text en Copyright © 2022 International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All rights reserved. https://creativecommons.org/licenses/by-nc/4.0/This is a Platinum Open Access Journal distributed under the terms of the Creative Commons Attribution Non-Commercial License which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Salvagno, Gian Luca
Henry, Brandon M.
De Nitto, Simone
Pighi, Laura
Lippi, Giuseppe
Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration
title Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration
title_full Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration
title_fullStr Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration
title_full_unstemmed Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration
title_short Correlation Between Time to Positive Result of SARS-CoV-2 Rapid Antigen Self-Test and Viral Antigen Concentration
title_sort correlation between time to positive result of sars-cov-2 rapid antigen self-test and viral antigen concentration
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9768622/
https://www.ncbi.nlm.nih.gov/pubmed/36605302
work_keys_str_mv AT salvagnogianluca correlationbetweentimetopositiveresultofsarscov2rapidantigenselftestandviralantigenconcentration
AT henrybrandonm correlationbetweentimetopositiveresultofsarscov2rapidantigenselftestandviralantigenconcentration
AT denittosimone correlationbetweentimetopositiveresultofsarscov2rapidantigenselftestandviralantigenconcentration
AT pighilaura correlationbetweentimetopositiveresultofsarscov2rapidantigenselftestandviralantigenconcentration
AT lippigiuseppe correlationbetweentimetopositiveresultofsarscov2rapidantigenselftestandviralantigenconcentration