Update on serologic testing in COVID–19

Krajewski, Rafał; Gołębiowska, Justyna; Makuch, Sebastian; Mazur, Grzegorz; Agrawal, Siddarth

doi:10.1016/j.cca.2020.09.015

Cited by 33 publications

(28 citation statements)

References 30 publications

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“…As regards serological tests, the search for IgM and IgG antibodies begins to yield positivity at approximately one month after the presumed infection and the levels of these immunoglobulins remain high for long periods of time. Of note, the IgM serum levels decrease significantly after six weeks from the onset of symptoms ( 35 ). The detection of viral proteins and mucosal IgA antibodies is also very important.…”

Section: The Right Test On the Right Sample At The Right Timementioning

confidence: 99%

Current and innovative methods for the diagnosis of COVID‑19 infection (Review)

et al. 2021

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The Coronavirus Disease 2019 (COVID-19) pandemic has forced the scientific community to rapidly develop highly reliable diagnostic methods in order to effectively and accurately diagnose this pathology, thus limiting the spread of infection. Although the structural and molecular characteristics of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were initially unknown, various diagnostic strategies useful for making a correct diagnosis of COVID-19 have been rapidly developed by private research laboratories and biomedical companies. At present, rapid antigen or antibody tests, immunoenzymatic serological tests and molecular tests based on RT-PCR are the most widely used and validated techniques worldwide. Apart from these conventional methods, other techniques, including isothermal nucleic acid amplification techniques, clusters of regularly inter-spaced short palindromic repeats/Cas (CRISPR/Cas)-based approaches or digital PCR methods are currently used in research contexts or are awaiting approval for diagnostic use by competent authorities. In order to provide guidance for the correct use of COVID-19 diagnostic tests, the present review describes the diagnostic strategies available which may be used for the diagnosis of COVID-19 infection in both clinical and research settings. In particular, the technical and instrumental characteristics of the diagnostic methods used are described herein. In addition, updated and detailed information about the type of sample, the modality and the timing of use of specific tests are also discussed.

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Section: The Right Test On the Right Sample At The Right Timementioning

confidence: 99%

Current and innovative methods for the diagnosis of COVID‑19 infection (Review)

et al. 2021

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“…In this context, the IFCC interim guidelines on serological testing of antibodies against SARS-CoV-2 were published recently [10] . There is consensus that serological testing can be helpful 1) in diagnosing SARS-CoV-2 infection in symptomatic hospitalized patients (especially if molecular biology testing is repeatedly negative); 2) to detect a previous infection with SARS-CoV-2 in hospitalized and non-hospitalized patients; 3) to estimate the extent of antibody production in a patient; 4) to determine the rate of individuals in certain populations who have already had contact with SARS-CoV-2 (e.g., for prevalence studies, for monitoring development of herd immunity); and possibly also 4) to detect antibody production following COVID-19 vaccination [10] , [11] , [12] , [13] .…”

Section: Introductionmentioning

confidence: 99%

Antibodies against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in individuals with and without COVID-19 vaccination: A method comparison of two different commercially available serological assays from the same manufacturer

Mueller

2021

Clinica Chimica Acta

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Background We compared two serological assays from Roche Diagnostics in individuals with and without COVID-19 vaccination, namely the Elecsys Anti-SARS-CoV-2 assay (detecting antibodies against the nucleocapsid protein of SARS-CoV-2) and the Elecsys Anti-SARS-CoV-2 S assay (detecting antibodies against the spike protein of SARS-CoV-2). Methods With both assays, we analyzed 3033 serum samples collected from 2496 patients without COVID-19 vaccination. In addition, we studied 34 healthcare-workers who received two injections of the BNT162b2 COVID-19 vaccine from BioNTech/Pfizer three weeks apart and who had repeatedly determined their antibody response by both assays. Results In our cohort of patients without COVID-19 vaccination, 62.9% of all determinations were negative with both Roche assays and 31.5% were positive with both assays. In 5.6% of our cohort, however, there were discordant results with both assays (partly because initially discordant results of the two assays became concordantly positive over time). In the healthcare-workers with the COVID-19 vaccination, the results of the Roche anti-nucleocapsid assay remained negative throughout the observation period of 5 weeks after vaccination. The initially negative antibodies against the spike protein became positive with the Roche assay in all samples two weeks after the initial injection, and the serum concentrations of anti-spike antibodies increased constantly until 4–5 weeks after the initial injection. Conclusions Here, we provide information on serological testing with the two Roche assays, which may be important for the application of the two assays in clinical routine. There are differences in the pattern of antibodies in individuals with and without COVID-19 vaccination.

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“…This approach could discriminate immune people as health-care workers allowing to reopen activities and borders and follow the development of the herd immunity. Different methods for serological tests are currently available ( 20 ).…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence of SARS-CoV-2 Assessed by Four Chemiluminescence Immunoassays and One Immunocromatography Test for SARS-Cov-2

Pellegrino

Gallo

Pierri

et al. 2021

Front. Public Health

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The onset of the new SARS-CoV-2 coronavirus encouraged the development of new serologic tests that could be additional and complementary to real-time RT-PCR-based assays. In such a context, the study of performances of available tests is urgently needed, as their use has just been initiated for seroprevalence assessment. The aim of this study was to compare four chemiluminescence immunoassays and one immunochromatography test for SARS-Cov-2 antibodies for the evaluation of the degree of diffusion of SARS-CoV-2 infection in Salerno Province (Campania Region, Italy). A total of 3,185 specimens from citizens were tested for anti-SARS-CoV-2 antibodies as part of a screening program. Four automated immunoassays (Abbott and Liaison SARS-CoV-2 CLIA IgG and Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays) and one lateral flow immunoassay (LFIA Technogenetics IgG–IgM COVID-19) were used. Seroprevalence in the entire cohort was 2.41, 2.10, 1.82, and 1.85% according to the Liaison IgG, Abbott IgG, Siemens, and Roche total Ig tests, respectively. When we explored the agreement among the rapid tests and the serologic assays, we reported good agreement for Abbott, Siemens, and Roche (Cohen's Kappa coefficient 0.69, 0.67, and 0.67, respectively), whereas we found moderate agreement for Liaison (Cohen's kappa coefficient 0.58). Our study showed that Abbott and Liaison SARS-CoV-2 CLIA IgG, Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays, and LFIA Technogenetics IgG-IgM COVID-19 have good agreement in seroprevalence assessment. In addition, our findings indicate that the prevalence of IgG and total Ig antibodies against SARS-CoV-2 at the time of the study was as low as around 3%, likely explaining the amplitude of the current second wave.

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Update on serologic testing in COVID–19

Abstract: Highlights The role of serological testing is crucial in the clinical management of COVID-19. We discuss the utility of anti–SARS–CoV–2 serology testing in a clinical setting. Utilizing anti–SARS–CoV2 detection in the advanced stage of infection is recommended.

Cited by 33 publications

References 30 publications

Current and innovative methods for the diagnosis of COVID‑19 infection (Review)

Current and innovative methods for the diagnosis of COVID‑19 infection (Review)

Antibodies against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in individuals with and without COVID-19 vaccination: A method comparison of two different commercially available serological assays from the same manufacturer

Seroprevalence of SARS-CoV-2 Assessed by Four Chemiluminescence Immunoassays and One Immunocromatography Test for SARS-Cov-2

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