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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 - 06/08/20

Doi : 10.1016/j.jinf.2020.06.023 
Jhong-Lin Wu a, Wen-Pin Tseng a, Chien-Hao Lin a, Tai-Fen Lee b, Ming-Yi Chung b, Chien-Hua Huang a, Shey-Ying Chen a, c, , Po-Ren Hsueh b, d, , Shyr-Chyr Chen a
a Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan 
b Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan 
c Center for Quality Management, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan 
d Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 

Corresponding author at: 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 MedicineNational Taiwan University HospitalNational Taiwan University College of Medicine7, Chung Shan South RoadTaipei100Taiwan⁎⁎Corresponding author at: Departments of Laboratory Medicine and Internal Medicine, National Taiwan University College of Medicine, 7, Chung Shan South Road, Taipei 100, Taiwan.Department of Laboratory MedicineNational Taiwan University HospitalNational Taiwan University College of Medicine7, Chung Shan South RoadTaipei100Taiwan

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Highlights

Performance of serological tests detecting SARS-CoV-2 antibodies is disease course dependent.
Detection sensitivity of rapid antibody tests with lateral flow immunoassay for COVID-19 reached 100% after 3 weeks of symptom onset.
COVID-19 patients with pneumonia exhibited earlier seroconversion than those without pneumonia.
Prolonged viral shedding after seroconversion with a median duration of 14 days was observed.
Serological testing may be a useful tool in addition to rRT-PCR for the diagnosis of COVID-19.

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SUMMARY

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.

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Keywords : COVID-19 pandemic, Antibody response, Rapid test, Immunochromatographic assay, Lateral flow method


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© 2020  Publié par Elsevier Masson SAS.
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Vol 81 - N° 3

P. 435-442 - septembre 2020 Retour au numéro
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