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Rapid Determination of SARS-CoV-2 antibodies using a bedside, point-of-Care, serological test.
Dortet, Laurent; Emeraud, Cecile; Vauloup-Fellous, Christelle; Khecharem, Mouna; Ronat, Jean-Baptiste; Fortineau, Nicolas; Roque-Afonso, Anne-Marie; Naas, Thierry.
  • Dortet L; Service de Bactériologie-hygiène, Hôpital Bicêtre, Inserm U1184; LabEx LERMIT, Université Paris-Saclay, APHP Paris-Saclay, Le Kremlin-Bicêtre, France.
  • Emeraud C; Service de Bactériologie-hygiène, Hôpital Bicêtre, Inserm U1184; LabEx LERMIT, Université Paris-Saclay, APHP Paris-Saclay, Le Kremlin-Bicêtre, France.
  • Vauloup-Fellous C; Service de Virologie, Hôpital Paul-Brousse, Inserm U1193; Université Paris-Saclay, APHP Paris-Saclay, Villejuif, France.
  • Khecharem M; Service de Bactériologie-hygiène, Hôpital Bicêtre, Inserm U1184; LabEx LERMIT, Université Paris-Saclay, APHP Paris-Saclay, Le Kremlin-Bicêtre, France.
  • Ronat JB; Médecins Sans Frontières, Mini-Lab project, Paris, France.
  • Fortineau N; Service de Bactériologie-hygiène, Hôpital Bicêtre, Inserm U1184; LabEx LERMIT, Université Paris-Saclay, APHP Paris-Saclay, Le Kremlin-Bicêtre, France.
  • Roque-Afonso AM; Service de Virologie, Hôpital Paul-Brousse, Inserm U1193; Université Paris-Saclay, APHP Paris-Saclay, Villejuif, France.
  • Naas T; Service de Bactériologie-hygiène, Hôpital Bicêtre, Inserm U1184; LabEx LERMIT, Université Paris-Saclay, APHP Paris-Saclay, Le Kremlin-Bicêtre, France.
Emerg Microbes Infect ; 9(1): 2212-2221, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-791927
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 and

methods:

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Serologic Tests / Coronavirus Infections / Clinical Laboratory Techniques / Point-of-Care Testing / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Emerg Microbes Infect Year: 2020 Document Type: Article Affiliation country: 22221751.2020.1826892

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Serologic Tests / Coronavirus Infections / Clinical Laboratory Techniques / Point-of-Care Testing / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Emerg Microbes Infect Year: 2020 Document Type: Article Affiliation country: 22221751.2020.1826892