Article ; Online: 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).
2020 Volume 129, Page(s) 104511
Abstract: ... 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 ... of this study was to assess the performance of three immunoassays for the detection of SARS-CoV-2 antibodies ...
| 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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| MeSH term(s) | Aged ; Antibodies, Viral/blood ; Automation, Laboratory/methods ; Betacoronavirus/immunology ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques/methods ; Coronavirus Infections/diagnosis ; Female ; Humans ; Immunoassay/methods ; Immunoglobulin A/blood ; Immunoglobulin G/blood ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/diagnosis ; Retrospective Studies ; SARS-CoV-2 ; Sensitivity and Specificity ; Serologic Tests/methods ; Time Factors |
| Chemical Substances | Antibodies, Viral ; Immunoglobulin A ; Immunoglobulin G |
| Keywords | covid19 |
| Language | English |
| Publishing date | 2020-06-15 |
| Publishing country | Netherlands |
| Document type | Comparative Study ; Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 1446080-4 |
| ISSN | 1873-5967 ; 1386-6532 |
| ISSN (online) | 1873-5967 |
| ISSN | 1386-6532 |
| DOI | 10.1016/j.jcv.2020.104511 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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