Abstract
ObjectivesA few studies on antibody testing have focused on asymptomatic or mild coronavirus disease 2019 (COVID-19) patients with low initial anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody responses. Anti-SARS-CoV-2 antibody-testing performance was evaluated using blood samples from asymptomatic or mild COVID-19 patients.MethodsBlood samples were collected from 143 COVID-19 patients during an outbreak on a cruise ship 3 weeks after diagnosis. Simultaneously, a follow-up SARS-CoV-2 genetic test was performed. Samples stored before the COVID-19 pandemic were also used to evaluate the lateral flow immunochromatographic assay (LFA) and electrochemiluminescence immunoassay (ECLIA). Titers of anti-SARS-CoV-2 IgM and IgG antibodies against the nucleocapsid and spike proteins were measured using the enzyme-linked immunosorbent assay to confirm which antibodies were influenced on LFA- and ECLIA- false-negative result in crew-member samples.ResultsSensitivity, specificity, positive-predictive, and negative-predictive values of LFA-detected IgM antibodies were 0.231, 1.000, 1.000, and 0.613, respectively; those of LFA-detected IgG antibodies were 0.483, 0.989, 0.972, and 0.601, respectively; and those of ECLIA-detected total antibodies were 0.783, 1.000, 1.000, and 0.848, respectively. All antibody titers measured using ELISA were significantly lower in blood samples with negative results than in those with positive results in both LFA and ECLIA. In the patients with negative results from the follow-up genetic testing, IgM-, IgG-, and total-antibody positivity rates were 22.9%, 47.6%, and 72.4%, respectively.ConclusionsThese findings suggest that anti-SARS-CoV-2 antibody testing has lower performance in asymptomatic or mild COVID-19 patients than required in the guidelines.
Highlights
The clinical indications for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) antibody testing are limited, many methods have been developed
In the patients with negative results from the follow-up genetic testing, IgM, IgG, and total-antibody positivity rates were 22.9%, 47.6%, and 72.4%, respectively. These findings suggest that anti-SARS-CoV-2 antibody testing has lower performance in asymptomatic or mild COVID-19 patients than required in the guidelines
We evaluated the performance of anti-SARS-CoV-2 antibody testing using the lateral flow immunochromatographic assay (LFA) and electrochemiluminescence immunoassay (ECLIA) in blood samples from crew members and those collected from patients between November 2014 and August 2019
Summary
The clinical indications for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) antibody testing are limited, many methods have been developed. The detection of anti-SARS-CoV-2 IgG or total antibodies at 3–4 weeks after symptom onset may be useful in determining past infection in selected clinical situations; data in this context are limited [1]. A previous study reported that initial anti-SARS-CoV-2 antibody responses were lower in asymptomatic or mild COVID-19 patients than in severe COVID-19 patients [4]. Since the percentage of asymptomatic COVID-19 patients in large-sample studies was 43.0%–76.5% [5], it is necessary to elucidate the performance of anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID19 patients. We preserved blood samples of asymptomatic or mild COVID-19 patients collected from a large cruise ship that had experienced a COVID-19 outbreak. Most patients received care on the ship because they were asymptomatic or did not need inpatient treatment, such as oxygen administration
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