Performance evaluation of an automated SARS-CoV-2 Ag test for the diagnosis of COVID-19 infection on nasopharyngeal swabs.
Clin Chem Lab Med
; 59(12): 2003-2009, 2021 Nov 25.
Article
in English
| MEDLINE | ID: covidwho-1334800
ABSTRACT
OBJECTIVES:
The detection of SARS-CoV-2 in infected people is a key tool to help in controlling COVID-19 pandemic. Like rapid antigenic tests, automated antigen tests, that present the advantage of a higher throughput flow, may be of interest. The LIAISON® SARS-CoV-2 Ag test was evaluated for the quantification of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs by comparison to RT-PCR.METHODS:
The study involved 378 nasopharyngeal samples (UTM® and FLOQSwab™, Copan Diagnostics), including 46 swabs positive for SARS-CoV-2 by RT-PCR. These samples came from asymptomatic (n=99, 26.2%) or symptomatic people (n=279, 73.8%), at different times from symptom onset. The samples were analyzed on LIAISON® XL.RESULTS:
The overall specificity was 99.4% (CI95% [98.6-100]). The negative predictive value reached 100% in asymptomatic people. Among the 46 positive samples, the overall sensitivity was 84.8% (CI95% [74.4-95.2]), reached 91.9% (CI95% [83.1-100]) in the first fourth days after symptoms onset and was 100% for Cq values ≤25. Antigen was not detected in samples with Cq values >25. Similar results were observed on nasopharyngeal swabs coming from patients infected with the 20I/501Y.V1 variant or the 20H/501Y.V2 variant.CONCLUSIONS:
According to technical performances, the LIAISON® SARS-CoV-2 Ag test may be a useful tool for COVID-19 diagnosis, especially during the first four days of symptoms.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Nasopharynx
/
Nucleocapsid
/
SARS-CoV-2
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
Topics:
Variants
Limits:
Humans
Language:
English
Journal:
Clin Chem Lab Med
Journal subject:
Chemistry, Clinical
/
Laboratory Techniques and procedures
Year:
2021
Document Type:
Article
Affiliation country:
Cclm-2021-0569
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