The evaluation of an automated mariPOC SARS-CoV-2 antigen test compared to RT-qPCR SARS-CoV-2 assay and comparison of its sensitivity in Delta- and Omicron-variant samples

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F22%3A10446551" target="_blank" >RIV/00064203:_____/22:10446551 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/22:10446551

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=cJxiih-eEQ" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=cJxiih-eEQ</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/irv.13048" target="_blank" >10.1111/irv.13048</a>

Jazyk výsledku

angličtina

Název v původním jazyce

The evaluation of an automated mariPOC SARS-CoV-2 antigen test compared to RT-qPCR SARS-CoV-2 assay and comparison of its sensitivity in Delta- and Omicron-variant samples

Popis výsledku v původním jazyce

Background The rapid diagnostics tests for SARS-CoV-2 antigen vary in their sensitivities, and moreover, genomic mutations may further affect the performance of the assays. We aimed to evaluate the analytical performance of an automated antigen assay and compare its sensitivity in Delta- and Omicron-variant positive clinical samples. Material and methods The analytical performance of an automated mariPOC SARS-CoV-2 antigen test was evaluated on a population of community-dwelling subjects with mild respiratory symptoms or being asymptomatic investigated by the RT-qPCR AllplexTM SARS-CoV-2 assay. The sensitivity and specificity of the antigen test were evaluated on prospective 621 nasopharyngeal swabs along with oropharyngeal swabs. The sensitivity regarding variants determined by the AllplexTM SARS-CoV-2 Variant assays was analysed in additional, retrospective 158 Delta and 59 Omicron samples. Results The overall sensitivity of the antigen test in prospective samples was 77.9% (113/145; 95% confidence interval [CI] 70.3-84.4) with the specificity of 99.8% (95% CI 98.8-100). Regarding the variant, the sensitivity was higher in Omicron-variant samples, 93.2% (55/59; 95% CI 83.5-98.1), compared to Delta-variant samples, 71.5% (113/158; 95% CI 63.8-78.4; p = .001). Conclusion In community-dwelling subjects with mild respiratory symptoms or being asymptomatic, the automated mariPOC SARS-CoV-2 antigen test showed high sensitivity over 98.0% in subgroup samples with cycle threshold (Ct) values &lt; 25. Regarding the variant, the antigen test sensitivity was higher in the Omicron-variant samples compared to the Delta-variant samples. The analytical performance of the antigen test can differ between the SARS-CoV-2 variants, and a re-evaluation should be performed for new circulating lineages.

Název v anglickém jazyce

The evaluation of an automated mariPOC SARS-CoV-2 antigen test compared to RT-qPCR SARS-CoV-2 assay and comparison of its sensitivity in Delta- and Omicron-variant samples

Popis výsledku anglicky

Background The rapid diagnostics tests for SARS-CoV-2 antigen vary in their sensitivities, and moreover, genomic mutations may further affect the performance of the assays. We aimed to evaluate the analytical performance of an automated antigen assay and compare its sensitivity in Delta- and Omicron-variant positive clinical samples. Material and methods The analytical performance of an automated mariPOC SARS-CoV-2 antigen test was evaluated on a population of community-dwelling subjects with mild respiratory symptoms or being asymptomatic investigated by the RT-qPCR AllplexTM SARS-CoV-2 assay. The sensitivity and specificity of the antigen test were evaluated on prospective 621 nasopharyngeal swabs along with oropharyngeal swabs. The sensitivity regarding variants determined by the AllplexTM SARS-CoV-2 Variant assays was analysed in additional, retrospective 158 Delta and 59 Omicron samples. Results The overall sensitivity of the antigen test in prospective samples was 77.9% (113/145; 95% confidence interval [CI] 70.3-84.4) with the specificity of 99.8% (95% CI 98.8-100). Regarding the variant, the sensitivity was higher in Omicron-variant samples, 93.2% (55/59; 95% CI 83.5-98.1), compared to Delta-variant samples, 71.5% (113/158; 95% CI 63.8-78.4; p = .001). Conclusion In community-dwelling subjects with mild respiratory symptoms or being asymptomatic, the automated mariPOC SARS-CoV-2 antigen test showed high sensitivity over 98.0% in subgroup samples with cycle threshold (Ct) values &lt; 25. Regarding the variant, the antigen test sensitivity was higher in the Omicron-variant samples compared to the Delta-variant samples. The analytical performance of the antigen test can differ between the SARS-CoV-2 variants, and a re-evaluation should be performed for new circulating lineages.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30303 - Infectious Diseases

Projekt

<a href="/cs/project/LX22NPO5103" target="_blank" >LX22NPO5103: Národní institut virologie a bakteriologie</a><br>

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Influenza and other Respiratory Viruses [online]

ISSN

1750-2659

e-ISSN

—

Svazek periodika

16

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

PL - Polská republika

Počet stran výsledku

7

Strana od-do

1033-1039

Kód UT WoS článku

000850137600001

EID výsledku v databázi Scopus

2-s2.0-85138275492