Serum samples were tested for antibodies (including IgG, IgA and IgM) against the nucleocapsid antigen of SARS-CoV-2 (N) using the Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics, Mannheim, Germany). The assay was performed on a Cobas e801 analyser (Roche Diagnostics, Mannheim, Germany) according to the manufacturer's instructions. The results showing a cut-off index (COI) of <1.0 were classified as negative, and a COI ≥1.0 was deemed positive for anti-SARS-CoV-2 antibodies (hereinafter referred to as seropositive). According to internal study data of Roche Diagnostics, the overall clinical specificity of the Elecsys Anti-SARS-CoV-2 immunoassay was 99.8% containing no cross-reactivity to the common cold coronaviruses, and additionally, a clinical sensitivity of 99.5% was calculated ≥14 days post polymerase chain reaction (PCR) confirmation. Serum samples with positive results were subject to SARS-CoV-2 neutralisation assay to detect SARS-CoV-2 neutralising antibodies with a titre of ≥1:10 being considered positive.22 (link)
Elecsys anti sars cov 2 immunoassay
Manufactured by Roche
Sourced in Switzerland, Germany, France
The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro diagnostic test used to detect antibodies against the SARS-CoV-2 virus. The test is designed to aid in the determination of the immune response to the SARS-CoV-2 virus.
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Lab products found in correlation
Elecsys anti sars cov 2 s immunoassay, by Roche (2 mentions)
Cobas e analyzer, by Roche (1 mentions)
Cobas 8000 analyzer system, by Roche (1 mentions)
Sars cov 2 surrogate virus neutralization test kit, by GenScript (1 mentions)
Architect analyzer, by Abbott (1 mentions)
Elecsys anti sars cov 2 kit, by Roche (1 mentions)
Cobas e 801 analyser, by Roche (1 mentions)
Viral rna mini kit, by Qiagen (1 mentions)
Steponeplus real time pcr system, by Thermo Fisher Scientific (1 mentions)
Vikia hbs ag, by bioMérieux (1 mentions)
Cobas 6000, by Roche (1 mentions)
26 protocols using elecsys anti sars cov 2 immunoassay
1
Elecsys Anti-SARS-CoV-2 Antibody Detection
2
Seroprevalence of SARS-CoV-2 Antibodies
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Samples were tested for SARS-CoV-2 antibodies using the Elecsys Anti-SARS-CoV-2 immunoassay, designed for Cobas e analyzers (Roche Diagnostics GmbH, Mannheim, Germany), which uses a recombinant nucleocapsid protein (N) for identifying the presence of the total antibodies against SARS-CoV-2 (IgM, IgA, and IgG). The Elecsys® is a double-antigen sandwich assay that uses the nucleocapsid protein for identifying specifically the presence of the total antibodies against SARS-CoV-2 infections, which are not generated after vaccination [14 (link),15 (link),16 (link)]. Antibodies to the nucleocapsid protein detect natural SARS-CoV-2 infection because this antigen is not targeted by the currently available vaccines in Europe [17 (link)]. The Elecsys® has a specificity of 99.80% and a sensitivity of 99.5% for past infection in patients at ≥14 days after PCR confirmation. Interpretation of results was based on manufacturer’s criteria: samples with cutoff index ≥1.0 were considered positive. Quality control was performed according to the protocol specified by the manufacturer.
Sera were tested at the Clinical Laboratory of the Municipal Clinical Emergency Teaching Hospital in Timisoara, a reference laboratory for COVID 19 testing in Romania.
Sera were tested at the Clinical Laboratory of the Municipal Clinical Emergency Teaching Hospital in Timisoara, a reference laboratory for COVID 19 testing in Romania.
3
SARS-CoV-2 Diagnosis and Antibody Assay
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Diagnostic RT-PCR (Seegene, Roche or Gene Xpert) for SARS-CoV-2 was performed using nasopharyngeal or oropharyngeal aspirates sampled at the time of enrollment. SARS-CoV-2 specific antibodies were assayed by the Elecsys® Anti-SARS-CoV-2 immunoassay (Roche Diagnostics). The assay was interpreted according to the manufacturer’s instructions (Roche: V 1.0 2020-05).
4
Measuring SARS-CoV-2 Neutralizing Antibodies
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The anti-RBD IgG and anti-RBD IgA concentrations in venous blood were measured using an in-house direct ELISA as previously described (33 (link), 34 (link), 40 (link)). The RBD of the SARS-CoV-2 Spike protein plays a crucial role in the cell entry-mechanism necessary for viral replication (41 (link)). This means that the RBD of the SARS-CoV-2 Spike protein is an important functional target of anti-SARS-CoV-2 antibodies (42 (link)). By measuring antibodies binding to the SARS-CoV-2 Spike protein RBD we measure antibodies with potential to neutralize SARS-CoV-2 virus replication (42 (link), 43 (link)). Furthermore, an in-house pseudo neutralization ELISA was used to estimate the neutralizing capacity of antibodies against the ancestral (Wuhan) strain of SARS-CoV-2 as previously described (33 (link), 34 (link), 43 (link)). Specific antibodies against the SARS-CoV-2 nucleocapsid (N) antigen not included in the vaccines used in Denmark were measured using the Elecsys® Anti-SARS-CoV-2 immunoassay (Roche Diagnostics GmbH, Germany) and a Cobas 8000 analyzer system (Roche Diagnostics), according to the manufacturer’s instructions.
5
Elecsys Anti-SARS-CoV-2 Immunoassay Evaluation
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A commercial Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics, Basel, Switzerland) targeting combined immunoglobulin (Ig) G and IgM against severe acute respiratory syndrome coronavirus-2 was performed at the Nutritional Research Laboratory at Aga Khan University. The manufacturer reported specificity >99.8% and sensitivity of 100% for individuals with a positive PCR test at least 2 weeks previously, and 88.1% sensitivity for individuals 7–13 days after a PCR-positive test (Roche Diagnostics, 2020 ).
6
SARS-CoV-2 T Cell and Antibody Responses
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Data on SARS-CoV-2-specific T cell responses assessed by interferon-γ (IFN-γ) enzyme-linked immunospot (ELISpot) assay, anti-SARS-CoV-2 nucleocapsid antibody titers assessed by Elecsys® anti-SARS-CoV-2 immunoassay (Roche Diagnostics), and anti-SARS-CoV-2 spike antibody titers assessed by Euroline Anti-SARS-CoV-2® (Euroimmune) were retrieved from a previous publication (Nelde et al., 2021 (link)). For this analysis, we considered SARS-CoV-2-specific T cell response intensities against the previously described SARS-CoV-2-specific epitope compositions for human leukocyte antigen (HLA) class I and HLA-DR. These SARS-CoV-2-specific epitope compositions were designed from immunogenic SARS-CoV-2-derived T cell epitopes, derived from different open reading frames, including spike, nucleocapsid, and membrane proteins, and recognized exclusively in convalescent patients after SARS-CoV-2 infection and not in SARS-CoV-2 unexposed individuals. The HLA class I and HLA-DR epitope compositions cover several different HLA class I and HLA-DR allotypes, respectively, to allow for standardized evaluation and determination of intensities of SARS-CoV-2-specific T cell responses. The intensity of T cell responses was measured as mean spot counts of duplicates in the ELISpot assay normalized to 5 × 105 cells minus the normalized mean spot count of the respective negative control.
7
SARS-CoV-2 Antibody Detection Assays
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Total antibodies anti-SARS-CoV-2 were determined by ELISA using Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland). The immunoassay utilizes a double-antigen sandwich test principle and a recombinant protein representing the nucleocapsid antigen for the determination of antibodies (including both IgA and IgG) to SARS-CoV-2. Assay results were interpreted as follows: cutoff index, <1.0 for samples that were nonreactive/negative for anti-SARS-CoV-2 antibodies; cutoff index, ≥1.0 for samples that were reactive/positive for anti-SARS-CoV-2 antibodies.
Neutralizing antibodies were detected by ELISA using GenScript SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit. Detect circulating neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the ACE2 cell surface receptor. The assay detects any antibodies in serum and plasma that neutralize the RBD-ACE2 interaction, the test is both species and isotype independent. We use dilution 1:20 of each serum and inhibition of neutralization were calculated as follow: Inhibition = (1—OD value of Sample/OD value of Negative Control) × 100%.
Neutralizing antibodies were detected by ELISA using GenScript SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit. Detect circulating neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the ACE2 cell surface receptor. The assay detects any antibodies in serum and plasma that neutralize the RBD-ACE2 interaction, the test is both species and isotype independent. We use dilution 1:20 of each serum and inhibition of neutralization were calculated as follow: Inhibition = (1—OD value of Sample/OD value of Negative Control) × 100%.
8
Evaluating COVID-19 Vaccine Antibody Levels
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Given the high risks for this population, the levels of anti-spike protein antibodies against SARS-CoV-2 were measured in patients and healthcare workers after they received anti-COVID vaccination at the two facilities to prevent a COVID-19 outbreak. Anti-spike protein antibodies were measured using the Elecsys® Anti-SARS-CoV-2 immunoassay (Roche Diagnostics International Ltd., Switzerland) at three time points, 3 weeks after the first injection, and at 2 and 3 weeks after the second injection, respectively. The “lower detection limit” and “cut-off level for a seronegative result” were 0.4 U/mL and 0.8 U/mL, respectively. An effective protective IgG level was determined to be ≥ 29 U/mL [14 ] based on the reported virus-neutralization ability [15 (link)]. Furthermore, we tested the presence of nucleocapsid (N) antibodies using the Elecsys® assay to exclude subjects with a COVID-19 history [cut-off index < 1.0 interpreted as non-reactive (negative)]. Patient background data were obtained from their medical records, and routine blood test results were obtained just before the first dose of BNT162b2 was administered as part of routine clinical practice. Blood test results and body mass index of healthcare workers were obtained during the routine health check.
9
SARS-CoV-2 Antibody Measurement via Elecsys Assay
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The measurement of SARS-CoV-2-specific antibodies was performed using the Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics, Basel, Switzerland). This semiquantitative electrochemiluminescence immunoassay measures SARS-CoV-2 nucleocapsid-specific IgG. The assay was performed by the South African National Health Laboratory Service and interpreted according to the manufacturer's instructions (Roche: version 1.0 2020-05). Results are reported as numeric values in the form of a cut-off index (COI) (signal sample/cut-off), where a COI <1.0 corresponds to nonreactive plasma and a COI ⩾1.0 corresponds to reactive plasma. At 14 days post-SARS-CoV-2 PCR confirmation, the sensitivity and specificity of the Elecsys Anti-SARS-CoV-2 immunoassay has been reported as 99.5% (95% CI 97.0–100.0%) and 99.80% (95% CI 99.69–99.88%), respectively [10 (link)–12 (link)].
10
COVID-19 Vaccine Antibody Monitoring
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Antibody levels against the viral spike antigen (IgG anti-S) were assessed at 4 predetermined time points: 0-5 days before the second dose of the vaccination (Baseline Test) and 30, 60, and 180 days after the second dose (Tests #1, #2, and #3, respectively). The participants were tested for COVID-19 blood S1/S2 IgG type antibodies (Abs), using Liaison chemiluminescent immunoassay kit (DiaSorin, Saluggia, Italy; REF 311450) to assess immunological status after vaccination.
Infection with SARS-CoV-2 was diagnosed either by a positive RT-PCR in a nasal swab or, retrospectively, by a positive anti-nucleocapsid antibody test (anti-N). All participants underwent two tests for anti-N antibodies on each occasion where IgG anti-S were measured, using both the Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics, Basel, Switzerland) on a Cobas analyzer and the Abbott SARS-CoV-2 IgG nucleocapsid protein assay (Abbott, Abbott Park, IL) on an Architect analyzer.
Infection with SARS-CoV-2 was diagnosed either by a positive RT-PCR in a nasal swab or, retrospectively, by a positive anti-nucleocapsid antibody test (anti-N). All participants underwent two tests for anti-N antibodies on each occasion where IgG anti-S were measured, using both the Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics, Basel, Switzerland) on a Cobas analyzer and the Abbott SARS-CoV-2 IgG nucleocapsid protein assay (Abbott, Abbott Park, IL) on an Architect analyzer.
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