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Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2.
J Infect. 2020 Sep; 81(3):435-442.JI

Abstract

OBJECTIVES

We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients.

METHODS

This retrospective study enrolled 16 real-time reverse transcription polymerase chain reaction-confirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3-month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow immunoassays (LFIA) (ALLTEST 2019-nCoV IgG/IgM Rapid Test, Dynamiker 2019-nCoV IgG/IgM Rapid Test, ASK COVID-19 IgG/IgM Rapid Test, and Wondfo SARS-CoV-2 Antibody Test). Time-dependent detection sensitivity and timeliness of seroconversion were determined and compared between the four POC rapid tests.

RESULTS

The overall sensitivity and specificity of the four tests for detecting anti-SARS-CoV-2 antibodies after 3 weeks of symptom onset were 100% and 100%, respectively. There was no significant difference between the rapid tests used for detection of IgM and IgG separately and those used for detection of combined total antibody (mainly IgM/IgG). There was no significant difference between the four POC rapid tests in terms of time required for determining seroconversion of COVID-19. Patients with COVID-19 with pneumonia demonstrated shorter seroconversion time than those without pneumonia.

CONCLUSION

Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia.

Authors+Show Affiliations

Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan; Center for Quality Management, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: erdrcsy@gmail.com.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: hsporen@ntu.edu.tw.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

32553841

Citation

Wu, Jhong-Lin, et al. "Four Point-of-care Lateral Flow Immunoassays for Diagnosis of COVID-19 and for Assessing Dynamics of Antibody Responses to SARS-CoV-2." The Journal of Infection, vol. 81, no. 3, 2020, pp. 435-442.
Wu JL, Tseng WP, Lin CH, et al. Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2. J Infect. 2020;81(3):435-442.
Wu, J. L., Tseng, W. P., Lin, C. H., Lee, T. F., Chung, M. Y., Huang, C. H., Chen, S. Y., Hsueh, P. R., & Chen, S. C. (2020). Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2. The Journal of Infection, 81(3), 435-442. https://doi.org/10.1016/j.jinf.2020.06.023
Wu JL, et al. Four Point-of-care Lateral Flow Immunoassays for Diagnosis of COVID-19 and for Assessing Dynamics of Antibody Responses to SARS-CoV-2. J Infect. 2020;81(3):435-442. PubMed PMID: 32553841.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2. AU - Wu,Jhong-Lin, AU - Tseng,Wen-Pin, AU - Lin,Chien-Hao, AU - Lee,Tai-Fen, AU - Chung,Ming-Yi, AU - Huang,Chien-Hua, AU - Chen,Shey-Ying, AU - Hsueh,Po-Ren, AU - Chen,Shyr-Chyr, Y1 - 2020/06/15/ PY - 2020/05/09/received PY - 2020/05/30/revised PY - 2020/06/01/accepted PY - 2020/6/20/pubmed PY - 2020/8/29/medline PY - 2020/6/20/entrez KW - Antibody response KW - COVID-19 pandemic KW - Immunochromatographic assay KW - Lateral flow method KW - Rapid test SP - 435 EP - 442 JF - The Journal of infection JO - J Infect VL - 81 IS - 3 N2 - OBJECTIVES: We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients. METHODS: This retrospective study enrolled 16 real-time reverse transcription polymerase chain reaction-confirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3-month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow immunoassays (LFIA) (ALLTEST 2019-nCoV IgG/IgM Rapid Test, Dynamiker 2019-nCoV IgG/IgM Rapid Test, ASK COVID-19 IgG/IgM Rapid Test, and Wondfo SARS-CoV-2 Antibody Test). Time-dependent detection sensitivity and timeliness of seroconversion were determined and compared between the four POC rapid tests. RESULTS: The overall sensitivity and specificity of the four tests for detecting anti-SARS-CoV-2 antibodies after 3 weeks of symptom onset were 100% and 100%, respectively. There was no significant difference between the rapid tests used for detection of IgM and IgG separately and those used for detection of combined total antibody (mainly IgM/IgG). There was no significant difference between the four POC rapid tests in terms of time required for determining seroconversion of COVID-19. Patients with COVID-19 with pneumonia demonstrated shorter seroconversion time than those without pneumonia. CONCLUSION: Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia. SN - 1532-2742 UR - https://www.unboundmedicine.com/medline/citation/32553841/Four_point_of_care_lateral_flow_immunoassays_for_diagnosis_of_COVID_19_and_for_assessing_dynamics_of_antibody_responses_to_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0163-4453(20)30404-7 DB - PRIME DP - Unbound Medicine ER -