Abstract
ABSTRACT.Antibody tests can be tools for detecting current or past severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 [coronavirus disease 2019 (COVID-19)]) infections. Independent test evaluations are needed to document the performance with different sample sets. We evaluated six lateral flow assays (LFAs) and two laboratory-based tests (EUROIMMUN-SARS-CoV-2 ELISA and Abbott-Architect-SARS-CoV-2-IgG). We tested 210 plasma samples from 89 patients diagnosed with acute COVID-19. These samples were collected at different time points after the onset of symptoms. In addition, 80 convalescent plasma samples, and 168 pre-pandemic samples collected from adults in the United States and in Africa were tested. LFA performance varied widely, and some tests with high sensitivity had low specificity. LFA sensitivities were low (18.8–40.6%) for samples collected 0 to 3 days after symptom onset, and were greater (80.3–96.4%) for samples collected > 14 days after symptom onset. These results are similar to those obtained by ELISA (15.6% and 89.1%) and chemiluminescent microparticle assay (21.4% and 93.1%). The range of test specificity was between 82.7% and 97%. The combined use of two LFAs can increase specificity to more than 99% without a major loss of sensitivity. Because of suboptimal sensitivity with early COVID-19 samples and background reactivity with some pre-pandemic samples, none of the evaluated tests alone is reliable enough for definitive diagnosis of COVID-19 infection. However, antibody testing may be useful for assessing the status of the epidemic or vaccination campaign. Some of the LFAs had sensitivities and specificities that were comparable to those of more expensive laboratory tests, and these may be useful for seroprevalence surveys in resource-limited settings.
Highlights
IntroductionAs of October 13, 2020 about 37.9 million severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections (coronavirus disease 2019 [COVID-19]) and 1.01 million deaths have been recorded worldwide.[1]
As of October 13, 2020 about 37.9 million severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and 1.01 million deaths have been recorded worldwide.[1]
Our study focused on the evaluation of rapid, point-of-care tests using lateral flow assay (LFA) technology that could be especially helpful for antibody testing in low- and middleincome countries
Summary
As of October 13, 2020 about 37.9 million severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections (coronavirus disease 2019 [COVID-19]) and 1.01 million deaths have been recorded worldwide.[1]. Potential use cases for COVID-19 antibody testing have been reviewed previously.[5] It is clear that antibody test results alone for individual patients do not provide diagnostic certainty, because no test has 100% sensitivity and specificity. Positive antibody test results do not guarantee immunity, they suggest prior infection and immunity. Despite these limitations, antibody tests can be useful tools for assessing COVID-19 activity in communities, and they may have some value for individual diagnosis. Antibody tests can be useful tools for assessing COVID-19 activity in communities, and they may have some value for individual diagnosis This is especially true in low- and Antibody tests for COVID-19 use a variety of test platforms, but they use a limited number of viral antigens. Several test evaluation studies have recently been published or posted online, most compare a limited number of antibody tests with a relatively small panel of samples from a single geographic area.[11,15,16,17] more independent test evaluation data from various geographic regions are urgently needed
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