Diagnostic performance of seven rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients

Elslande, Jan Van; Houben, Els; Depypere, Maarten; Brackenier, A.; Desmet, Stefanie; André, Emmanuel; Ranst, Marc Van; Lagrou, Katrien; Vermeersch, Pieter

doi:10.1016/j.cmi.2020.05.023

Cited by 240 publications

(261 citation statements)

References 14 publications

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“…However, this was not possible here as we were testing sensitivity and specificity in specific time frames. Considering that these borderline samples were collected from RT-PCR-positive patients, borderline results were considered positive, consistent with similar studies ( Van Elslande et al, 2020 , Meyer et al, 2020 ). Interestingly, only one pre-pandemic sample with positive anti-MERS-CoV IgG antibodies was found positive by four ELISA kits ( Table 3 and S3), except Lionex, which demonstrated the highest specificity at 98.6% ( Figure 1 ).…”

Section: Discussionsupporting

confidence: 79%

“…A microplate reader, Epoch 2 microplate spectrophotometer (Bio-Tek, Italy) was used to read the optical density (OD) in all ELISA reactions. Borderline results were considered positive ( Van Elslande et al, 2020 , Meyer et al, 2020 ).…”

Section: Methodsmentioning

confidence: 99%

“…Since the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak in December 2019 in Wuhan, China, the virus has rapidly spread and become a major public health concern all over the world ( Van Elslande et al, 2020 , Ong et al, 2020 ). As of July 1, 2020, the virus has caused more than 10 million confirmed infections and over 500,000 reported deaths ( Organization, W.H., 2020 ).…”

Section: Introductionmentioning

confidence: 99%

“…Specific antibodies against SARS-CoV-2 can be detected as early as 4-7 days in approximately 40% of COVID-19 patients, with seroconversion rates reaching more than 90% by day 14 ( Zhao et al, 2020 ). Therefore, serology could be used as a complementary test to RT-PCR to improve the diagnostic sensitivity, particularly in suspected COVID-19 individuals with negative RT-PCR results or those with no respiratory sample collected during the acute phase of illness ( Van Elslande et al, 2020 , Ong et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

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Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies

Yassine¹,

Al-Jighefee²,

Al-Sadeq³

et al. 2021

International Journal of Infectious Diseases

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Highlights Performances of five commercial ELISA (EDI, AnshLabs, Dia.Pro, NovaTec, and Lionex) for detecting anti-SARS-CoV-2 IgG was evaluated. Samples used in this study are from diverse national background and the negative group contains samples that are seropositive for all other HCoV. All assays showed low sensitivity during the early stages (≤7 from symptom onset); however, it was greatly improved overtime. Lionex showed the highest specificity (98.6%), followed by EDI and Dia.Pro (97.1%,), NovaTec (85.7%), and AnshLabs (75.7%). Lionex, which measures antibodies to the S1 protein, demonstrated the best performance and doesn’t cross-react with any other HCoV.

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Section: Discussionsupporting

confidence: 79%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies

Yassine¹,

Al-Jighefee²,

Al-Sadeq³

et al. 2021

International Journal of Infectious Diseases

View full text Add to dashboard Cite

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“…LFIA tests could prove useful in the emergency room, ambulatory and outpatient settings rather than simply abandoned for its relatively poor performance. We didn’t pool our analysis based on assays from different companies, but other head-to-head studies had shown a variable accordance between different assays within only a small group of participants 28 , 38 , 46 , 55 . A recent study showed a high accordance between Abbott Architect, DiaSorin Liaison, Ortho VITROS, and Euroimmun among 1200 serum samples 56 .…”

Section: Discussionmentioning

confidence: 99%

Meta-analysis of diagnostic performance of serology tests for COVID-19: impact of assay design and post-symptom-onset intervals

Wang

Loeffelholz

et al. 2020

Emerging Microbes & Infections

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Serology detection is recognized for its sensitivity in convalescent patients with COVID-19, in comparison with nucleic acid amplification tests (NAATs). This article aimed to evaluate the diagnostic accuracy of serologic methods for COVID-19 based on assay design and post-symptom-onset intervals. Two authors independently searched PubMed, Cochrane library, Ovid, EBSCO for case–control, longitudinal and cohort studies that determined the diagnostic accuracy of serology tests in comparison with NAATs in COVID-19 cases and used QUADAS-2 for quality assessment. Pooled accuracy was analysed using INLA method. A total of 27 studies were included in this meta-analysis, with 4 cohort, 16 case–control and 7 longitudinal studies and 4565 participants. Serology tests had the lowest sensitivity at 0–7 days after symptom onset and the highest at >14 days. TAB had a better sensitivity than IgG or IgM only. Using combined nucleocapsid (N) and spike(S) protein had a better sensitivity compared to N or S protein only. Lateral flow immunoassay (LFIA) had a lower sensitivity than enzyme-linked immunoassay (ELISA) and chemiluminescent immunoassay (CLIA). Serology tests will play an important role in the clinical diagnosis for later stage COVID-19 patients. ELISA tests, detecting TAB or targeting combined N and S proteins had a higher diagnostic sensitivity compared to other methods.

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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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Diagnostic performance of seven rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients

Cited by 240 publications

References 14 publications

Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies

Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies

Meta-analysis of diagnostic performance of serology tests for COVID-19: impact of assay design and post-symptom-onset intervals

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

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