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Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: Two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech).
Nicol, Thomas; Lefeuvre, Caroline; Serri, Orianne; Pivert, Adeline; Joubaud, Françoise; Dubée, Vincent; Kouatchet, Achille; Ducancelle, Alexandra; Lunel-Fabiani, Françoise; Le Guillou-Guillemette, Hélène.
  • Nicol T; Virology Department, Angers University Hospital, Angers, France.
  • Lefeuvre C; Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.
  • Serri O; Virology Department, Angers University Hospital, Angers, France.
  • Pivert A; Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.
  • Joubaud F; Department of Biochemistry and Genetics, Angers University Hospital, Angers, France.
  • Dubée V; Infectious Diseases and Tropical Medicine, University Hospital of Angers, Angers, France; Equipe ATIP AVENIR, CRCINA, INSERM, University of Nantes and Angers.
  • Kouatchet A; Medical Intensive Care Department, University Hospital of Angers, Angers, France.
  • Ducancelle A; Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.
  • Lunel-Fabiani F; Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.
  • Le Guillou-Guillemette H; Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France. Electronic address: heleguillou@chu-angers.fr.
J Clin Virol ; 129: 104511, 2020 08.
Article in English | MEDLINE | ID: covidwho-598658
ABSTRACT

BACKGROUND:

The emergence of new SARS-CoV-2 has promoted the development of new serological tests that could be complementary to RT-PCR. Nevertheless, the assessment of clinical performances of available tests is urgently required as their use has just been initiated for diagnose.

OBJECTIVES:

The aim of this study was to assess the performance of three immunoassays for the detection of SARS-CoV-2 antibodies.

METHODS:

Two automated immunoassays (Abbott SARS-CoV-2 CLIA IgG and Euroimmun Anti-SARS-CoV-2 ELISA IgG/IgA assays) and one lateral flow immunoassay (LFIA NG-Test® IgG-IgM COVID-19) were tested. 293 specimens were analyzed from patients with a positive RT-PCR response, from patients with symptoms consistent with COVID-19 but exhibiting a negative response to the RT-PCR detection test, and from control group specimens. Days since symptoms onset were collected from clinical information sheet associated with respiratory tract samples.

RESULTS:

Overall sensitivity for IgG was equivalent (around 80 %) for CLIA, ELISA and LFIA. Sensitivity for IgG detection, >14 days after onset of symptoms, was 100.0 % for all assays. Overall specificity for IgG was greater for CLIA and LFIA (more than 98 %) compared to ELISA (95.8 %). Specificity was significantly different between IgA ELISA (78.9 %) and IgM LFIA (95.8 %) (p < 0.05). The best agreement was observed between CLIA and LFIA assays (97 %; k = 0.936).

CONCLUSION:

Excellent sensitivity for IgG detection was obtained >14 days after onset of symptoms for all immunoassays. Specificity was also excellent for IgG CLIA and IgG LFIA. Our study shows that NG-Test® is reliable and accurate for routine use in clinical laboratories.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoassay / Serologic Tests / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104511

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoassay / Serologic Tests / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104511