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Elia sars cov 2 sp1 igg

Manufactured by Thermo Fisher Scientific
Sourced in Sweden

The EliA SARS-CoV-2-Sp1 IgG is a laboratory assay designed to detect the presence of IgG antibodies to the S1 protein of the SARS-CoV-2 virus. The assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection.

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4 protocols using elia sars cov 2 sp1 igg

1

SARS-CoV-2 Spike Protein Antibody Assay

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Anti-SARS-CoV-2 antibodies, directed to spike protein, were tested using the EliA SARS-CoV-2-Sp1 IgG (Thermo Fisher, Uppsala, Sweden). It is a fluoroenzyme-immunoassay (FEIA) for the quantitative detection of IgG antibodies in serums toward the SARS-CoV-2 spike 1 protein on the Phadia 250 instrument.
The EliA SARS-CoV-2-Sp1 IgG well is coated with a recombinant SARS-CoV-2 S1 protein. The cut-off value is 28 BAU/mL, as declared by the manufacturer.
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2

SARS-CoV-2 Spike Protein Antibody Assay

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Six millilitres of venous blood were collected into an EDTA tube. The blood samples were centrifuged at 1500 rpm for 10 min to obtain serum samples, which were then stored at −20 °C until antibody analysis. Specific antibody (IgG) titres against the SARS-CoV-2-spike protein were measured using a fluoroenzyme immunoassay (EliA SARS-CoV-2-Sp1 IgG, Thermo Fisher Scientific, Waltham, MA, USA) (negative: < 7 U/ml, equivocal range 7–10 U/ml, positive: > 10 U/ml). A titre > 10 U/ml was considered positive for an antibody against the SARS-CoV-2-spike protein. According to the Department of Medical Sciences of the Thai Ministry of Public Health, this test has a diagnostic sensitivity of 98 % and specificity of 100 % (analysis no. CV93). In addition, previous studies demonstrated that this test has a diagnostic sensitivity and specificity of 96.9–100 % and 99.4–100 %, respectively [22] (link), [23] (link), [24] (link), [25] (link).
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3

Comparison of SARS-CoV-2 Antibody Assays

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The SARS-CoV-2 antibody assays compared in this study are listed in Table 2, including short names used throughout the article. Analysis was performed by experienced medical laboratory technicians following the manufacturer’s instructions including internal quality control. A single proficiency test was performed for all assays using sample material from the UKNEQAS quality assurance program (6 ). The manufacturers’ recommended cutoff values were used in interpretation of the results. Borderline results [Thermo Fisher Scientific EliA™ SARS-CoV-2-Sp1 IgG (Thermo Fisher Scientific [TFS]-receptor binding domain [RBD]-IgG) 7–10 EliA U/mL (n = 37) and WANTAI SARS-CoV-2 Ab ELISA (Wantai-RBD-total) 0.9–1.1 absorbance/calculated cutoff (A/CO) (n = 6)] were not interpreted as either positive or negative but included as “no valid result.”
The TFS-RBD-IgG assay received CE approval halfway through the study and changed output unit. The results in µg/L were converted to EliA U/mL using a lot-specific correction factor supplied by the manufacturer.
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4

Quantitative Measurement of SARS-CoV-2 S1 IgG

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EliA SARS-CoV-2-Sp1 IgG: The EliA SARS-CoV-2-Sp1 IgG (Thermo Fisher S1 IgG) is a fluoroenzyme-immunoassay (FEIA) for the in vitro quantitative measurement of IgG antibodies in human serum and plasma directed to the S1 protein [24] , performed on the Phadia 250 instrument (Thermo Fisher, Uppsala, Sweden). The EliA SARS-CoV-2-Sp1 IgG wells are coated with recombinant SARS-CoV-2 S1 protein.
After washing non-bound antibodies, enzyme-labelled anti-human IgG are added to form antibody-conjugate complexes incubated with a development solution. After stopping the reaction, the fluorescence in the reaction mixture is measured. The cut-off value in AU/mL, the conversion factor to obtain BAU/mL, the cut-off value in BAU/mL and the linearity range in AU/mL are respectively: 7.0, 4.0, 28 and 0.7-204, as declared by the manufacturer. Samples with values above 204 AU/ mL (816 BAU/mL) were diluted and measured 1:2 allowing the extension of the dynamic range up to 408 AU/mL (1,632 BAU/mL). According to the manufacturer, intra-and inter-assay precision data ranges between 2.1 and 3.1%; clinical specificity is 99.7% (95% CI: 98.4-100%) and clinical sensitivity is 100% (95% CI: 99.5-100%), calculated at eight days or more, after the first positive PCR.
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