1. Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2
- Author
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Jhong Lin Wu, Shyr-Chyr Chen, Chien Hao Lin, Wen Pin Tseng, Po-Ren Hsueh, Tai Fen Lee, Ming Yi Chung, Chien-Hua Huang, and Shey-Ying Chen
- Subjects
Adult ,Male ,0301 basic medicine ,Microbiology (medical) ,Point-of-Care Systems ,Pneumonia, Viral ,030106 microbiology ,COVID-19 pandemic ,Context (language use) ,Antibodies, Viral ,Sensitivity and Specificity ,Article ,Serology ,Betacoronavirus ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Serologic Tests ,030212 general & internal medicine ,Lateral flow method ,Viral shedding ,Seroconversion ,Pandemics ,Retrospective Studies ,Point of care ,Immunoassay ,Rapid test ,biology ,SARS-CoV-2 ,business.industry ,COVID-19 ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Virus Shedding ,Pneumonia ,Infectious Diseases ,Immunoglobulin M ,Case-Control Studies ,Immunoglobulin G ,Antibody response ,Immunology ,biology.protein ,Female ,Antibody ,Coronavirus Infections ,business ,Immunochromatographic assay - Abstract
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., 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.
- Published
- 2020