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Architect sars cov 2 igg assay

Manufactured by Abbott
Sourced in United States, Brazil

The Architect SARS-CoV-2 IgG assay is a quantitative laboratory test designed to detect and measure the presence of antibodies against the SARS-CoV-2 virus in human serum or plasma samples. The assay is intended for use on the Architect i System, a fully automated immunoassay analyzer.

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18 protocols using architect sars cov 2 igg assay

1

SARS-CoV-2 Screening in Cancer Patients

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All consecutive patients treated at the outpatient department of the “Franz Tappeiner” Hospital Merano, from 15 March to 26 May 2020 were included in this retrospective study. Specific infection prevention and control measures were maintained by the hospital as well as our clinic as described previously [14 (link)]. Universal baseline testing for SARS-CoV‑2 RNA was performed using a real-time polymerase chain reaction (RT-PCR) on respiratory samples obtained from nasopharyngeal swabs of patients and all healthcare workers. Furthermore, from 22 June to 17 July 2020 a total of 250 consecutive cancer patients who underwent SARS-CoV‑2 PCR baseline testing as well as the entire healthcare team were tested for the presence of IgG antibodies against SARS-CoV‑2 in venous blood samples. Serologic testing was performed using the commercially available Abbott Architect SARS-CoV‑2 IgG assay to detect immunoglobulin class G (IgG) antibodies to the nucleocapsid protein of SARS-CoV‑2 (Abbott Diagnostics, Chicago, Ill, USA). Sensitivity and specificity for the Abbott Architect SARS-CoV‑2 IgG assay were found to be 100% and 99.6%, respectively [15 (link)]. The study was approved by the local ethics committee of the “Südtiroler Sanitätsbetrieb” (protocol number 35-2020).
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2

SARS-CoV-2 IgG Antibody Detection

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Testing for SARS-CoV-2 IgG was performed on the Abbott Architect using the Abbott Architect SARS-CoV-2 IgG assay (Abbott Diagnostics, Abbott Park, Illinois, United States).23 (link) Sera and plasma specimens were stored at 2 °C – 8 °C for not more than 7 days and −20 °C for long-term (> 7 days) storage. The assay is an automated two-step chemiluminescent microparticle immunoassay for qualitative detection of SARS-CoV-2 IgG antibodies against the SARS-CoV-2 nucleocapsid protein. The assay was performed and interpreted according to the manufacturer’s instructions.24
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3

Comprehensive SARS-CoV-2 Antibody Profiling

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Retention EDTA plasma samples were aliquoted and frozen at -20°C at the CBS laboratory in Ottawa. Each sample was tested for SARS-CoV-2 IgG antibodies using four assays. The Abbott Architect SARS-Cov-2 IgG assay which targets the nucleocapsid antigen (Abbott-NP), (Abbott, Chicago IL) and three in-house IgG ELISA chemiluminescent assays recognizing distinct recombinant viral antigens: full length spike glycoprotein (Spike), spike glycoprotein receptor binding domain (RBD), and nucleocapsid (NP), were tested at the CBS laboratory in Ottawa and the Gingras laboratory [11 (link), 12 (link)] at the LTRI in Toronto, respectively. Table 1 summarizes each antibody assay by: platform, antigen targets and how reactivity was determined.
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4

SARS-CoV-2 Antibody Assay Evaluation

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Serum specimens were initially analyzed using the qualitative Abbott Architect SARS-CoV-2 IgG assay (anti-N assay), which detects antibodies to the nucleocapsid protein of SARS-CoV-2; this assay has an index value of 1.4 as the positivity threshold (Abbott Laboratories, Abbott Park, IL) [22 ]. Results are reported as positive (≥ 1.4) or negative (< 1.4). Index values do not represent antibody titer levels, but are semi-quantitative values calculated from calibrator standards [22 ] and were used to evaluate relative changes over time. Anti-SARS-CoV-2 signal-to threshold ratios were calculated by dividing the IgG index value by 1.4 (threshold for positivity). Trends were evaluated as the percent change from semester start to semester end.
In addition, serum samples were also analyzed using the AdviseDx SARS-CoV-2 IgG II assay (anti-S assay) [23 ]. This assay detects antibodies to the receptor binding domain of the S1 subunit of the spike protein of SARS-CoV-2 and has a positivity threshold of  ≥ 50 arbitrary units/mL (AU/mL) of serum (Abbott Laboratories, Abbott Park, IL) [23 ].
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5

Serologic Assays for SARS-CoV-2 Antibodies

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We used 3 serologic assays to detect the presence of SARS-CoV-2 antibodies. The Abbott Architect SARS-CoV-2 IgG assay (Abbott, https://www.corelaboratory.abbott) is a chemiluminescent microparticle immunoassay for detecting IgG against the SARS-CoV-2 nucleoprotein and has sensitivity and specificity close to 100% (6 (link),7 ). The EUROIMMUN SARS-CoV-2 assay (EUROIMMUN, https://www.euroimmun.com) is an ELISA for detecting IgG and IgA against the SARS-CoV-2 S1 domain of the spike glycoprotein, including the immunologically relevant receptor-binding domain. This assay was reported to have a clinical specificity of 98% for IgG and 91% for IgA detection, with a maximal sensitivity reached after 28 days after symptom onset (IgG 98% and IgA 95%) (7 ). The Biosynex COVID-19 BSS assay (Biosynex, https://www.biosynex.com) is a lateral flow assay for detecting IgM and IgG directed against the SARS-CoV-2 receptor-binding domain of the spike glycoprotein and has a sensitivity of 95.6% and a specificity of 99.4% (8 (link)). All 3 assays were approved by the French National Agency of Medicine and Health Products Safety for their excellent analytical performances. All tests were performed according to manufacturer instructions.
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6

Comparative Analysis of SARS-CoV-2 Antibody Assays

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All serological tests were performed using both the Abbott ARCHITECT SARS-CoV-2 IgG Assay (Abbott Laboratories, Abbott Park, IL, USA), an automated two-step immunoassay using SARS-CoV-2 antigen-coated paramagnetic microparticles, and the Roche Elecsys® Anti-SARS-CoV-2 Assay (Roche Diagnostics GmbH – Mannheim, Germany), an electro-chemiluminescence immunoassay that quantifies total SARS-CoV-2-specific immunoglobulin (19 (link)). The Abbott ARCHITECT SARS-CoV-2 IgG Assay specifically measures anti-SARS-CoV-2 IgG antibodies whereas the Roche Elecsys® Anti-SARS-CoV-2 Assay measures total anti-SARS-CoV-2 antibody, resulting in ~35-fold higher antibody titers in the Roche assay.
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7

SARS-CoV-2 IgG Antibody Detection

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All samples were collected and stored at −20°C until use. IgG antibodies against SARS-CoV-2 were detected using a laboratory-based quantitative assay (Abbott ARCHITECT SARS-CoV-2 IgG Assay; chemiluminescence microparticle immunoassay; sensitivity: 100%, specificity: 99.6%; Abbott Laboratories, IL, USA) performed on the Abbott Architect i4000SR (Abbott Diagnostics, IL, USA) at the Division of Clinical Laboratory in our hospital according to the manufacturer's instructions. This assay is designed to detect IgG antibodies against the nucleocapsid protein of SARS-CoV-2 in the serum and plasma. The Food and Drug Administration has not fully authorized any COVID-19 test, but this kit has been authorized for emergency use.[6 ]
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8

SARS-CoV-2 Serology Assay Evaluation

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The SARS-CoV-2 serology testing was done using the commercial test kits available in each participating hospital. Hospital 1 used the Abbott Architect SARS-CoV-2 IgG assay, Abbott Laboratories, Maidenhead, UK (IgG Sensitivity = 100%, IgG Specificity = 99.6%), the others used the Roche Elecsys Anti-SARS-CoV-2, Roche Diagnostics International Ltd, Rotkreuz, Switzerland (total antibody) assay (Pan IgG Sensitivity = 100%, Pan IgG Specificity = 99.8%). Sensibility and specificity are reported according to the EUA Authorized Serology Test Performance [7 ].
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9

Orthogonal Antibody Testing for COVID-19

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We tested specimens using an orthogonal approach, where specimens were analysed using two independent tests in sequential approach [14 ]. All samples were first tested using the Abbott Architect SARS-CoV-2 IgG assay (Abbott Laboratories, Abbott Park, Illinois, US), which detects anti-nucleocapsid antibodies. Samples that were positive with the Architect SARS-CoV-2 IgG assay were then tested using the VITROS anti-SARS-CoV-2 IgG assay, which detects anti-spike antibodies (Ortho-Clinical Diagnostics, Raritan, New Jersey, US). These assays were validated in-house with the same set of specimens and were each found to have 92.3% (95% CI: 81.5–97.9) sensitivity for specimens collected > 14 days from symptom onset or from date of PCR specimen collection, and 100.0% (95% CI: 96.4–100.0) specificity. Only specimens that tested positive by both assays were considered positive, otherwise they were considered negative.
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10

Telephone Interviews for COVID-19 Serology

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Telephone interviews were conducted by trained research personnel to record demographics, occupation, underlying medical conditions, illness history, testing location, and social histories using a standardized case report form. Travel history was included if the person traveled within 14 days before illness onset or enrollment date if the person was asymptomatic. Results from clinical SARS‐CoV‐2 tests were reviewed and verified. Trained research personnel scheduled and collected research blood specimens at each participant's property within 6 weeks following enrollment. Sera collected on March 20–July 21, 2020, were provided to the Tennessee Department of Health, Division for Laboratory Services for SARS‐CoV‐2 antibody detection using the Architect SARS‐CoV‐2 IgG assay (Abbott). All data and laboratory results were maintained in a secure REDCap™ (Research Electronic Data Capture, Vanderbilt University) database.6
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