Rapid Determination of SARS-CoV-2 antibodies using a bedside, point-of-Care, serological test.
Emerg Microbes Infect
; 9(1): 2212-2221, 2020 Dec.
Article
en En
| MEDLINE
| ID: mdl-32969769
ABSTRACT
Background:
Several serological tests for SARS-CoV-2 have been developed or use, but most have only been validated on few samples, and none provide medical practitioners with an easy-to-use, self-contained, bedside test with high accuracy. Material andmethods:
Two-hundred fifty-six sera from 101 patients hospitalized with SARS-CoV-2 infection (positive RT-PCR) and 50 control sera were tested for IgM/IgG using the NG-Test IgM-IgG COVID all-in-one assay. The seroconversion dynamic was assessed by symptom onset and day of RT-PCR diagnosis.Results:
Among the SARS-CoV-2 infected patients, positive IgG and/or IgM result was observed for 67.3% of patients (68/101), including 17 (16.8%) already positive at the day of RT-PCR, and 51 (50.5%) with observable seroconversion, and 32.7% (33/101) remained negative as subsequent sampling was not possible (patient discharge or death). The sensitivity increased with the delay between onset of symptoms and sampling, going from 29.1%, 78.2% and 86.5% for the time periods of 0-9-, 10-14- and >14-days after the onset of symptoms, respectively. Cumulative sensitivity, specificity, Positive Predictive Value and Negative Predictive Value were 97.0%, 100%, 100% and 96.2%, respectively 15-days after the onset of symptoms. No difference in seroconversion delay was observed regardless of whether patients received ventilation.Conclusions:
The NG-test is a bedside serological assay that could serve as a complementary source of diagnostic information to RT-PCR and chest imaging. It may also be useful to monitor immunological status of medical and non-medical workers during the ongoing pandemic, and the general population after social distancing measures have eased.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Neumonía Viral
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Pruebas Serológicas
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Infecciones por Coronavirus
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Técnicas de Laboratorio Clínico
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Pruebas en el Punto de Atención
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Betacoronavirus
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Anticuerpos Antivirales
Tipo de estudio:
Diagnostic_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Emerg Microbes Infect
Año:
2020
Tipo del documento:
Article
País de afiliación:
Francia