tetano
Editor, Senior Moderator
Emerg Microbes Infect
. 2020 Sep 17;1-60.
doi: 10.1080/22221751.2020.1825016. Online ahead of print.
Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan
Shey-Ying Chen[SUP] 1 2 [/SUP], Yu-Lin Lee[SUP] 3 [/SUP], Yi-Chun Lin[SUP] 4 5 [/SUP], Nan-Yao Lee[SUP] 6 7 [/SUP], Chia-Hung Liao[SUP] 8 [/SUP], Yuan-Pin Hung[SUP] 7 9 10 [/SUP], Min-Chi Lu[SUP] 11 12 [/SUP], Jhong-Lin Wu[SUP] 1 [/SUP], Wen-Pin Tseng[SUP] 1 [/SUP], Chien-Hao Lin[SUP] 1 [/SUP], Ming-Yi Chung[SUP] 13 [/SUP], Chun-Min Kang[SUP] 13 14 [/SUP], Ya-Fan Lee[SUP] 13 [/SUP], Tai-Fen Lee[SUP] 13 [/SUP], Chien-Yu Cheng[SUP] 4 15 [/SUP], Cheng-Pin Chend[SUP] 16 [/SUP], Chien-Hua Huang[SUP] 1 [/SUP], Chun-Eng Liu[SUP] 4 [/SUP], Shu-Hsing Cheng[SUP] 4 17 [/SUP], Wen-Chien Ko[SUP] 6 7 [/SUP], Po-Ren Hsueh[SUP] 13 18 [/SUP], Shyr-Chyr Chen[SUP] 1 [/SUP]
Affiliations
Abstract
This multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e., two chemiluminescence immunoassays (CLIAs): Roche Elecsys? Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4-99.0%), Abbott Test (94.0%, 89.1-96.8%), Wondfo Test (91.4%, 85.8-94.9%), ASK Test (97.4%, 93.4-99.0%), and Dynamiker Test (90.1%, 84.3-94.0%) after > 21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3-99.7%) for the Roche Test, 97.9% (95% CI, 94.8-99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1-100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.
Keywords: Antibody response; COVID-19; Chemiluminescence immunoassays; Cross-reactivity; Lateral flow immunoassays.
. 2020 Sep 17;1-60.
doi: 10.1080/22221751.2020.1825016. Online ahead of print.
Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan
Shey-Ying Chen[SUP] 1 2 [/SUP], Yu-Lin Lee[SUP] 3 [/SUP], Yi-Chun Lin[SUP] 4 5 [/SUP], Nan-Yao Lee[SUP] 6 7 [/SUP], Chia-Hung Liao[SUP] 8 [/SUP], Yuan-Pin Hung[SUP] 7 9 10 [/SUP], Min-Chi Lu[SUP] 11 12 [/SUP], Jhong-Lin Wu[SUP] 1 [/SUP], Wen-Pin Tseng[SUP] 1 [/SUP], Chien-Hao Lin[SUP] 1 [/SUP], Ming-Yi Chung[SUP] 13 [/SUP], Chun-Min Kang[SUP] 13 14 [/SUP], Ya-Fan Lee[SUP] 13 [/SUP], Tai-Fen Lee[SUP] 13 [/SUP], Chien-Yu Cheng[SUP] 4 15 [/SUP], Cheng-Pin Chend[SUP] 16 [/SUP], Chien-Hua Huang[SUP] 1 [/SUP], Chun-Eng Liu[SUP] 4 [/SUP], Shu-Hsing Cheng[SUP] 4 17 [/SUP], Wen-Chien Ko[SUP] 6 7 [/SUP], Po-Ren Hsueh[SUP] 13 18 [/SUP], Shyr-Chyr Chen[SUP] 1 [/SUP]
Affiliations
- PMID: 32940547
- DOI: 10.1080/22221751.2020.1825016
Abstract
This multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e., two chemiluminescence immunoassays (CLIAs): Roche Elecsys? Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4-99.0%), Abbott Test (94.0%, 89.1-96.8%), Wondfo Test (91.4%, 85.8-94.9%), ASK Test (97.4%, 93.4-99.0%), and Dynamiker Test (90.1%, 84.3-94.0%) after > 21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3-99.7%) for the Roche Test, 97.9% (95% CI, 94.8-99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1-100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.
Keywords: Antibody response; COVID-19; Chemiluminescence immunoassays; Cross-reactivity; Lateral flow immunoassays.