ArticleClinica chimica acta; international journal of clinical chemistry2020
Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples.
Article in Clinica chimica acta; international journal of clinical chemistry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Antibody tests for identification of current and past infection with SARS-CoV-2.The Cochrane database of systematic reviews · 2022Pooled it
- A systematic review and meta-analysis of the accuracy of SARS-COV-2 IGM and IGG tests in individuals with COVID-19.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022Pooled it
- Article
- Comparative performance of the InBios SCoV-2 DetectWellcome open research · 2024Article
- Comparison of capillary blood self-collection using the Tasso-SST device with venous phlebotomy for anti-SARS-CoV-2 antibody measurement.Journal of immunological methods · 2023Article
- Risk factors and characteristics influencing humoral response to COVID-19 vaccination in patients after allogeneic stem cell transplantation.Frontiers in immunology · 2023Article
- HLA-DR polymorphism in SARS-CoV-2 infection and susceptibility to symptomatic COVID-19.Immunology · 2022Observational
- Comparison of SARS-CoV-2 Antibodies and Six Immunoassays in Pediatric and Adult Patients 12 Weeks After COVID-19.Cureus · 2022Article
- Stability of SARS-CoV-2 IgG in multiple laboratory conditions and blood sample types.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2021Article
- Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay.Laboratory medicine · 2021Article
- Assessing the Quality of Serological Testing in the COVID-19 Pandemic: Results of a European External Quality Assessment (EQA) Scheme for Anti-SARS-CoV-2 Antibody Detection.Journal of clinical microbiology · 2021Article
- Comprehensive evaluation of eight commercial SARS-CoV-2 IgG assays.Diagnostic microbiology and infectious disease · 2021Article
- Longitudinal assessment of anti-SARS-CoV-2 antibody dynamics and clinical features following convalescence from a COVID-19 infection.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021Article
- Development of in-house ELISAs for the detection of anti-SARS‑CoV‑2 RBD and N IgG and IgM antibodies in biological samples.Journal of King Saud University. Science · 2021Article
- A multiplex antigen microarray for simultaneous IgG and IgM detection against SARS-CoV-2 reveals higher seroprevalence than reported.Microbial biotechnology · 2021Article
- Longitudinal assessment of symptoms and risk of SARS-CoV-2 infection in healthcare workers across 5 hospitals to understand ethnic differences in infection risk.EClinicalMedicine · 2021Article
- Specificity testing by point prevalence as a simple assessment strategy using the Roche Elecsys® anti-SARS-CoV-2 immunoassay.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021Article
- Point-of-care test system for detection of immunoglobulin-G and -M against nucleocapsid protein and spike glycoprotein of SARS-CoV-2.Sensors and actuators. B, Chemical · 2021Article
- The seroprevalence and kinetics of IgM and IgG in the progression of COVID-19.BMC immunology · 2021Article
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Corrections and comments
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFor epidemiologic, social and economic reasons, assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection prevalence and immunity are important to adapt decisions to current demands. Hence, immunoassays for detection of anti-SARS-CoV-2 antibodies are introduced rapidly without requiring FDA emergency use authorization approval. Thus, evaluation of test performance predominantly relies on laboratories. This study aimed to evaluate the test performance of recently launched commercial immunoassays in serum and plasma samples.
methods51 serum samples from 26 patients with confirmed SARS-CoV-2 infection after end of quarantine and 25 control patients were analyzed using anti-SARS-CoV-2 IgG immunoassays from Roche, Euroimmun and Epitope to assess diagnostic sensitivity and specificity. 20 matching pairs of serum and plasma samples were included to analyze comparability between different specimens.
resultsOverall, a diagnostic sensitivity of 92.3%, 96.2-100% and 100% with a respective diagnostic specificity of 100%, 100% and 84-86% for the immunoassays from Roche, Euroimmun and Epitope were determined. In total, 84-96% of samples were correctly classified as negative and 92.3-95.2% as positive. The level of concordance between plasma- and serum-based testing diverged between the assays (Epitope r
conclusionsThe immunoassays from Euroimmun and Roche revealed a higher specificity than the Epitope assay without a substantial drop of diagnostic sensitivity. Significant differences between plasma- and serum-based testing highlights the need for determination of appropriate cut-offs per specimen type. Hence, there is an urgent need for test harmonization and establishment of quality standards for an appropriate use of COVID-19 serological tests.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.