A lateral flow immunoassay test performance in SARS-CoV-2 seroprevalence surveys: a validation study among healthcare workers.
Emerg Microbes Infect
; 9(1): 2547-2549, 2020 Dec.
Article
in English
| MEDLINE | ID: covidwho-933806
ABSTRACT
The objective of this study was to evaluate the validity and reliability of NG-Test® when used as a finger-prick test on healthcare workers and to compare it to the ELISA Wantai Immunoassay. Fifty-one healthcare workers who were RT-PCR SARS-CoV-2 positive and 59 who were RT-PCR SARS-CoV-2 negative accepted to participate in this study. They were subjected to an NG-Test® finger-prick test and collection of a blood sample on the same day. A second NG-Test® on another finger was performed for the first 30 cases and controls and read blinded to the first. Sera obtained from blood samples were used to perform the Wantai SARS-CoV-2 ELISA. The interobserver agreement for the NG-Test® test was perfect (kappa coefficient = 100% [98%-100%]). The sensitivity of NG-Test® was estimated to be 85% [71.9%-92.3%] and the specificity 98.3% [95.0%-100.0%]) for both IgG and IgM. The percentage of agreement between the Wantai immunoassay and NG-Test® was 92.73% for IgG (Kappa = 0.85 [0.75-0.95]) and 65.45% (Kappa = 0.42 [0.26-0.58]) for IgM. Our study highlights the need to validate rapid immunoassay tests under real-life conditions. If NG-Test® is used in seroprevalence surveys, we recommend that its diagnostic performance be taken into consideration to obtain a reliable estimation.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Reagent Kits, Diagnostic
/
Immunoassay
/
Serologic Tests
/
Health Personnel
/
COVID-19
/
Antibodies, Viral
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
Emerg Microbes Infect
Year:
2020
Document Type:
Article
Affiliation country:
22221751.2020.1852893
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