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Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection.
J Clin Virol. 2020 08; 129:104529.JC

Abstract

BACKGROUND

COVID-19 pandemic has spread worldwide since December 2019. Serological tests for SARS-CoV-2 antibody testing are needed for detection of current or past infections. A wide range of commercial tests is available. However, most of them need to be validated.

STUDY DESIGN

The aim was to compare a commercial IgG and IgA ELISA (Euroimmun) with three lateral flow immunoassays (LFI): Hangzhou Alltest Biotech, Wuhan UNscience Biotechnology and Guangzhou Wondfo Biotech. Specificity was calculated with 62 available serum samples from 2018/19. The study included 152 sera from patients of which 109 were RT-PCR positive. Sensitivities for ELISA anti SARS-CoV-2 IgG and IgA were 81.5 % and 93.1 % and specificities 100 % and 80.6 %, respectively. LFI showed variable performances, overall results being better for Guangzhou Wondfo Biotech.

CONCLUSIONS

Commercial serological tests are useful for detection of antibodies in patients with COVID-19. ELISA presented better results than LFI. The results allowed to incorporate the most sensitive LFI to the daily workflow, combining with ELISA. Careful validation is encouraged before clinical laboratories start using these tests.

Authors+Show Affiliations

Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain. Electronic address: martinez_mariaser@gva.es.Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain; University of Medicine. Address: Av. Blasco Ibáñez 15, 46010, Valencia, Spain.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32659710

Citation

Serrano, Maria Martínez, et al. "Comparison of Commercial Lateral Flow Immunoassays and ELISA for SARS-CoV-2 Antibody Detection." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104529.
Serrano MM, Rodríguez DN, Palop NT, et al. Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection. J Clin Virol. 2020;129:104529.
Serrano, M. M., Rodríguez, D. N., Palop, N. T., Arenas, R. O., Córdoba, M. M., Mochón, M. D. O., & Cardona, C. G. (2020). Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104529. https://doi.org/10.1016/j.jcv.2020.104529
Serrano MM, et al. Comparison of Commercial Lateral Flow Immunoassays and ELISA for SARS-CoV-2 Antibody Detection. J Clin Virol. 2020;129:104529. PubMed PMID: 32659710.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection. AU - Serrano,Maria Martínez, AU - Rodríguez,David Navalpotro, AU - Palop,Nuria Tormo, AU - Arenas,Roberto Olmos, AU - Córdoba,Marta Moreno, AU - Mochón,Mª Dolores Ocete, AU - Cardona,Concepción Gimeno, Y1 - 2020/06/29/ PY - 2020/05/31/received PY - 2020/06/16/revised PY - 2020/06/27/accepted PY - 2020/7/14/pubmed PY - 2020/8/12/medline PY - 2020/7/14/entrez KW - Antibody detection KW - COVID-19 KW - Diagnosis KW - SARS-CoV-2 KW - Sensitivity KW - Specificity SP - 104529 EP - 104529 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - BACKGROUND: COVID-19 pandemic has spread worldwide since December 2019. Serological tests for SARS-CoV-2 antibody testing are needed for detection of current or past infections. A wide range of commercial tests is available. However, most of them need to be validated. STUDY DESIGN: The aim was to compare a commercial IgG and IgA ELISA (Euroimmun) with three lateral flow immunoassays (LFI): Hangzhou Alltest Biotech, Wuhan UNscience Biotechnology and Guangzhou Wondfo Biotech. Specificity was calculated with 62 available serum samples from 2018/19. The study included 152 sera from patients of which 109 were RT-PCR positive. Sensitivities for ELISA anti SARS-CoV-2 IgG and IgA were 81.5 % and 93.1 % and specificities 100 % and 80.6 %, respectively. LFI showed variable performances, overall results being better for Guangzhou Wondfo Biotech. CONCLUSIONS: Commercial serological tests are useful for detection of antibodies in patients with COVID-19. ELISA presented better results than LFI. The results allowed to incorporate the most sensitive LFI to the daily workflow, combining with ELISA. Careful validation is encouraged before clinical laboratories start using these tests. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32659710/Comparison_of_commercial_lateral_flow_immunoassays_and_ELISA_for_SARS_CoV_2_antibody_detection_ DB - PRIME DP - Unbound Medicine ER -