Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories

Harritshøj, Lene Holm; Gybel-Brask, Mikkel; Afzal, Shoaib; Kamstrup, Pia R.; Jørgensen, Charlotte Sværke; Thomsen, Marianne Kragh; Hilsted, Linda; Friis-Hansen, Lennart; Szecsi, Pal Bela; Pedersen, Lise; Nielsen, Lene; Hansen, Cecilie Bo; Garred, Peter; Korsholm, Trine‐Line; Mikkelsen, Susan; Nielsen, Knud Erik; Møller, Bjarne Kuno; Hansen, Anne Todsen; Iversen, Kasper; Nielsen, Pernille B; Hasselbalch, Rasmus Bo; Fogh, Kamille; Norsk, Jakob; Kristensen, Jonas Henrik; Schønning, Kristian; Kirkby, Nikolai; Nielsen, Alex Christian Yde; Landsy, Lone Hummelshøj; Loftager, Mette; Holm, Dorte Kinggaard; Nilsson, Anna Christine; Sækmose, Susanne Gjørup; Grum-Schwensen, Birgitte; Aagaard, Bitten; Jensen, Thøger Gorm; Nielsen, Dorte M.; Ullum, Henrik; Dessau, Ram Benny

doi:10.1128/jcm.02596-20

Cited by 115 publications

(119 citation statements)

References 28 publications

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“…In contrast to sensitivity, the specificities of LFA and ECLIA were very high in this study. These results were consistent with those of previous studies using the same kits [10–14]. Although there were no samples with false-positive results for LFA-detected anti-SARS-CoV-2 IgM antibodies and ECLIA-detected total antibodies, there were two samples with false-positive results for LFA-detected SARS-CoV-2 IgG antibodies.…”

Section: Discussionsupporting

confidence: 92%

“…[9] ECLIA’s sensitivity for anti-SARS-CoV-2 total antibodies was 0.783 in this study, which was higher than that of LFA. However, ECLIA’s sensitivity in this study was lower than that reported in previous studies using the same ECLIA kit; the sensitivity in previous studies was 0.920–0.995 [10–12]. One study reported that ECLIA’s sensitivity in all patients was 0.920–0.927; however, ECLIA’s sensitivity in 6 (4.0%) asymptomatic patients and 37 (24.8%) mild patients was reported to be approximately 0.800.…”

Section: Discussioncontrasting

confidence: 79%

“…One study reported that ECLIA’s sensitivity in all patients was 0.920–0.927; however, ECLIA’s sensitivity in 6 (4.0%) asymptomatic patients and 37 (24.8%) mild patients was reported to be approximately 0.800. [10] The results of this study demonstrated that ECLIA’s sensitivity in detecting anti-SARS-CoV-2 antibodies was relatively low in asymptomatic or mild COVID-19 patients. Considering the results of this study, the sensitivities of LFA and ECLIA in asymptomatic or mild COVID-19 patients were lower than the required clinical sensitivity in the guidelines.…”

Section: Discussionmentioning

confidence: 91%

“…Thus, other kits could have possibly had higher sensitivity in asymptomatic and mild COVID-19 patients than those used in this study. However, since the ECLIA used in this study demonstrated good sensitivity compared to other ECLIA kits,[10–12] it may be difficult to improve sensitivity by using others. Third, the time-course of the anti-SARS-CoV2 antibody testing was not evaluated in this study.…”

Section: Discussionmentioning

confidence: 99%

“…Third, the time-course of the anti-SARS-CoV2 antibody testing was not evaluated in this study. This study focused on the time point that was reported as one of the best times for anti-SARS-CoV2 antibody testing [7,9,10]; however, it is possible that the optimal time for anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID-19 patients varies. Finally, the neutralizing antibodies were not evaluated.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID-19 patients in outbreak on a cruise ship

Kaku

Nishimura

et al. 2021

Preprint

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Background A 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. Methods Blood samples were collected from 143 COVID-19 patients during an outbreak on a cruise ship 3 weeks after diagnosis. Simultaneously, a second 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 compare false-negative- with positive-result samples. Results Sensitivity, 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. IgM-, IgG-, and total-antibody positivity rates in the patients with negative results from the second genetic testing were 22.9%, 47.6%, and 72.4%, respectively. All antibody titers, especially those of the IgG antibody against nucleocapsid protein, were significantly lower in blood samples with false-negative results than in those with positive results. Conclusions 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, and situations in which it is useful are limited.

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Section: Discussionsupporting

confidence: 92%

Section: Discussioncontrasting

confidence: 79%

Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Evaluation of anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID-19 patients in outbreak on a cruise ship

Kaku

Nishimura

et al. 2021

Preprint

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Evaluation of Seropositivity Following BNT162b2 Messenger RNA Vaccination for SARS-CoV-2 in Patients Undergoing Treatment for Cancer

et al. 2021

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Key Points Question Do patients with cancer develop adequate antibody responses to messenger RNA SARS-CoV-2 vaccines? Findings In this cohort study that included 102 patients with cancer who were receiving active treatment and 78 healthy controls, 92 patients with cancer (90%) and 100% of the controls were seropositive after the second messenger RNA BNT162b2 vaccine dose.. Meaning The findings of this study suggest that patients with cancer who are receiving active treatment and are at higher risk for severe COVID-19 disease respond well to messenger RNA SARS-CoV-2 vaccines and that vaccination of these patients should be seriously considered.

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Antibody tests for identification of current and past infection with SARS-CoV-2

Fox

Geppert

Dinnes

et al. 2022

Cochrane Database of Systematic Reviews

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Background The diagnostic challenges associated with the COVID‐19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS‐CoV‐2 infection. Serology tests to detect the presence of antibodies to SARS‐CoV‐2 enable detection of past infection and may detect cases of SARS‐CoV‐2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS‐CoV‐2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS‐CoV‐2 epidemiology. Objectives To assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS‐CoV‐2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS‐CoV‐2. Sources of heterogeneity investigated included: timing of test, test method, SARS‐CoV‐2 antigen used, test brand, and reference standard for non‐SARS‐CoV‐2 cases. Search methods The COVID‐19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co‐ordinating Centre (EPPI‐Centre) ‘COVID‐19: Living map of the evidence’ and the Norwegian Institute of Public Health ’NIPH systematic and living map on COVID‐19 evidence’. We did not apply language restrictions. Selection criteria We included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT‐PCR test. Small studies with fewer than 25 SARS‐CoV‐2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS‐CoV‐2 (including reverse transcription polymerase chain reaction tests (RT‐PCR), clinical diagnostic criteria, and pre‐pandemic samples). Data collection and analysis We use standard screening procedures with three reviewers. Quality assessment (using the QUADAS‐2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta‐analysis, we fitted univariate random‐effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random‐effects logistic regression models. We tabulated result...

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Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories

Cited by 115 publications

References 28 publications

Evaluation of anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID-19 patients in outbreak on a cruise ship

Evaluation of anti-SARS-CoV-2 antibody testing in asymptomatic or mild COVID-19 patients in outbreak on a cruise ship

Evaluation of Seropositivity Following BNT162b2 Messenger RNA Vaccination for SARS-CoV-2 in Patients Undergoing Treatment for Cancer

Antibody tests for identification of current and past infection with SARS-CoV-2

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