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Atellica im sars cov 2 igg

Manufactured by Siemens
Sourced in France

The Atellica IM SARS-CoV-2 IgG is a laboratory equipment product designed to detect the presence of SARS-CoV-2 specific IgG antibodies in human serum or plasma samples. It is an in vitro diagnostic test used to aid in the diagnosis of COVID-19 infection.

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4 protocols using atellica im sars cov 2 igg

1

Serological Assessments of SARS-CoV-2 Antibodies

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Four antibody binding assays were used for serological testing according to the instructions of the manufacturer. Two were quantitative: Abbott SARS-CoV-2 IgG II Quant-test (Abbott) (Abbott France, Rungis, France) with 50 arbitrary units (AU)/ml as a threshold for positivity, and Roche Elecsys anti-SARS-CoV-2 S (Roche Diagnostics France, Meylan, France) with 0.8 AU/ml used as a threshold for positivity. Two were semi-quantitative: Beckman Access SARS-CoV-2 IgG II (Beckman Coulter France SAS, Roissy CDG, France) with 30 AU/ml as a threshold for positivity and Siemens Atellica® IM SARS-CoV-2 IgG (Siemens Healthcare SAS, Saint-Denis, France) with 0.8 AU/ml used as a threshold for positivity.
BAU/ml proposed by the WHO, to standardize any assay to the WHO International Standard, were calculated by applying the following conversion factors as suggested by the manufacturers: Abbott, BAU/ml = (1/7) × Antibody Units (AU)/ml, Beckman, BAU/ml = 1 × AU/ml, Roche, BAU/ml = 1.029 × AU/ml, and Siemens, BAU/ml = 21.8 × AU/ml.
The neutralizing capacity was estimated by performing a surrogate virus neutralization test (sVNT) assay (GenScript, Piscataway, NJ, USA) as previously described [10 (link),15 (link),16 (link)]. This assay detects antibodies that block the interaction of SARS-CoV-2 with its entry receptor angiotensin-converting enzyme 2. A threshold of 20% was used for positivity.
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2

SARS-CoV-2 Antibody Response in Pediatric Transplant Recipients

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Data were extracted from electronic health records at Rady Children’s Hospital San Diego. Variables obtained included age, sex, time from transplant, prior COVID-19 infection or hospitalization, prior SARS CoV-2 nucleocapsid (N) antibody presence, and type and dose of antimetabolite at time of vaccination. SARS-CoV-2 antibody assays were obtained as part of routine follow-up appointments a minimum of 4 weeks after the final vaccine dose. We utilized the Abbott chemiluminescent microparticle immunoassay or Siemens Atellica IM SARS-CoV-2 IgG. Both assays are commercially available and were designed to be specific to the receptor binding domain of the S1 subunit of the IM SARS-CoV-2 spike protein. Patients were characterized as vaccine responders if they had an antibody titer greater than 50 AU/mL for the Abbott assay or greater than 1.0 index for Siemens and were considered non-responders if below these thresholds. Two different assays were used because our center’s lab transitioned from sending out SARS-CoV-2 IgG studies to performing in-house testing during our period of data collection.
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3

Humoral Response to COVID-19 Vaccine Dose

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The humoral response to the third dose was measured two weeks after the vaccine administration with the Siemens Healthineers Atellica® IM SARS-CoV-2 IgG (sCOVG) assay, which detects anti-S1-RBD IgG. The assay is considered non-reactive when the result is less than 1 or reactive when greater than or equal to 1, with a maximum measurable range of up to 150 U/mL limiting the antibody response intensity analysis and constituting a potential source of bias. According to the manufacturer, this test has a 96.41% sensitivity (95% CI 92.74–98.54%) and 99.9% specificity (95% CI: 99.63–99.99%).
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4

SARS-CoV-2 Antibody Quantification

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End point binding immunoglobulin G (IgG) levels to the S1 domain of the spike protein of SARS-CoV-2 were measured using the semiquantitative Anti-SARS-CoV-2 ELISA IgG (Euroimmune, Lübeck, Germany), according to the manufacturer’s instructions. Positive responses included both IgG ratio ≥1.1 and borderline values of IgG between 0.8 and 1.0. Negative responses were IgG ratio <0.8. Cutoff values for lack of seroconversion (standard of active level) was set as <0.8. In addition, quantitative Anti-SARS-CoV-2 ELISA IgG measurement (Atellica IM SARS-CoV-2 IgG, Siemens) was performed with positive response ≥21.8 binding antibody unit/mL (BAU/mL) and negative <21.8 BAU/mL.
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