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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).
J Clin Virol. 2020 08; 129:104511.JC

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.

Authors+Show Affiliations

Virology Department, Angers University Hospital, Angers, France.Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.Virology Department, Angers University Hospital, Angers, France.Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.Department of Biochemistry and Genetics, Angers University Hospital, Angers, France.Infectious Diseases and Tropical Medicine, University Hospital of Angers, Angers, France; Equipe ATIP AVENIR, CRCINA, INSERM, University of Nantes and Angers.Medical Intensive Care Department, University Hospital of Angers, Angers, France.Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France.Virology Department, Angers University Hospital, Angers, France; HIFIH Laboratory EA 3859, LUNAM, Angers, France. Electronic address: heleguillou@chu-angers.fr.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32593133

Citation

Nicol, Thomas, et al. "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)." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104511.
Nicol T, Lefeuvre C, Serri O, et al. 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). J Clin Virol. 2020;129:104511.
Nicol, T., Lefeuvre, C., Serri, O., Pivert, A., Joubaud, F., Dubée, V., Kouatchet, A., Ducancelle, A., Lunel-Fabiani, F., & Le Guillou-Guillemette, H. (2020). 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). Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104511. https://doi.org/10.1016/j.jcv.2020.104511
Nicol T, et al. 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). J Clin Virol. 2020;129:104511. PubMed PMID: 32593133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Nicol,Thomas, AU - Lefeuvre,Caroline, AU - Serri,Orianne, AU - Pivert,Adeline, AU - Joubaud,Françoise, AU - Dubée,Vincent, AU - Kouatchet,Achille, AU - Ducancelle,Alexandra, AU - Lunel-Fabiani,Françoise, AU - Le Guillou-Guillemette,Hélène, Y1 - 2020/06/15/ PY - 2020/06/12/received PY - 2020/06/14/accepted PY - 2020/6/28/pubmed PY - 2020/8/12/medline PY - 2020/6/28/entrez KW - Automated immunoassays KW - COVID-19 KW - Lateral flow immunoassay KW - Performance KW - SARS-CoV-2 SP - 104511 EP - 104511 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32593133/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__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30253-5 DB - PRIME DP - Unbound Medicine ER -