Sars cov 2 igg assay

Manufactured by Abbott

Sourced in United States, Ireland

The SARS-CoV-2 IgG assay is a laboratory equipment product designed to detect the presence of IgG antibodies to the SARS-CoV-2 virus in human serum or plasma samples. The assay provides a qualitative measurement of the IgG immune response to the virus.

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SARS-CoV-2 IgG (39 citations)

96 protocols using sars cov 2 igg assay

Evaluating SARS-CoV-2 Antibody Assay Specificity

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To establish the required specificity of the assay, and for cross-reactivity testing, MFI cutoff values were determined by testing a total of 218 “pre-COVID-19” sera. These comprised sera from individuals positive for ANA (n = 20) or rheumatoid factor (n = 10) or from those serologically diagnosed with Lyme disease (n = 10), syphilis (n = 10), CMV infection (n = 10), EBV infection (n = 10), or non-SARS-CoV-2 respiratory illnesses (n = 55) and other negative samples (n = 93). To examine assay performance, sera (n = 125) from unique patients (i.e., n = 125) positive for SARS-CoV-2 nucleic acid and with a known date of symptom onset were tested. These samples were randomly selected and binned into 5 time intervals corresponding to ≤5, 6 to 10, 11 to 15, 16 to 20, and ≥21 days from symptom onset. Results were interpreted qualitatively, and concordance was established with respect to the Abbott SARS-CoV-2 IgG assay. Assay reproducibility was established by testing 5 replicates each of 3 serum samples testing positive by the Abbott Architect SARS-CoV-2 IgG assay (see Table S2 in the supplemental material).

Cameron A., Porterfield C.A., Byron L.D., Wang J., Pearson Z., Bohrhunter J.L., Cardillo A.B., Ryan-Muntz L., Sorensen R.A., Caserta M.T., Angeloni S., Hardy D.J., Zand M.S, & Pecora N.D. (2021). A Multiplex Microsphere IgG Assay for SARS-CoV-2 Using ACE2-Mediated Inhibition as a Surrogate for Neutralization. Journal of Clinical Microbiology, 59(2), e02489-20.

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SARS-CoV-2 IgG Antibody Detection

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Serum samples collected from individuals from the general population were tested for the presence of immunoglobulin G (IgG) antibodies against SARS-CoV-2 on the Advia Centaur Immunoassay system using the Siemens SARS-CoV-2 IgG assay (Siemens Healthineers, India, Mumbai) and Abbott Architect i2000SR automated analyser using the Abbott SARS-CoV-2 IgG assay (Abbott Park, IL, USA). The Siemens assay detects IgG antibodies against the spike protein of the receptor binding domain (S1-RBD), and the Abbott assay detects IgG antibodies against the nucleocapsid (N) protein of SARS-CoV-2. Serum samples from HCWs were tested only for IgG antibodies against the S1-RBD protein. Sensitivity and specificity of the Siemens IgG assay are 100% and 99.90% respectively, compared with 100% and 99.6% for the Abbott IgG assay (Center for Devices and Radiological Health, 2021 ). Serum samples with cut-off indices (COI) ≥1.0 on the Siemens IgG assay or ≥1.4 on the Abbott IgG assay were considered as positive for IgG antibodies against SARS-CoV-2. One hundred and fifty positive serum samples and 150 negative serum samples for each assay were retested for quality control purposes.

Murhekar M.V., Bhatnagar T., Thangaraj J.W., Saravanakumar V., Kumar M.S., Selvaraju S., Rade K., Kumar C.P., Sabarinathan R., Turuk A., Asthana S., Balachandar R., Bangar S.D., Bansal A.K., Chopra V., Das D., Deb A.K., Devi K.R., Dhikav V., Dwivedi G.R., Khan S.M., Kumar M.S., Laxmaiah A., Madhukar M., Mahapatra A., Rangaraju C., Turuk J., Yadav R., Andhalkar R., Arunraj K., Bharadwaj D.K., Bharti P., Bhattacharya D., Bhat J., Chahal A.S., Chakraborty D., Chaudhury A., Deval H., Dhatrak S., Dayal R., Elantamilan D., Giridharan P., Haq I., Hudda R.K., Jagjeevan B., Kalliath A., Kanungo S., Krishnan N.N., Kshatri J.S., Kumar A., Kumar N., Kumar V.G., Lakshmi G.G., Mehta G., Mishra N.K., Mitra A., Nagbhushanam K., Nimmathota A., Nirmala A.R., Pandey A.K., Prasad G.V., Qurieshi M.A., Reddy S.D., Robinson A., Sahay S., Saxena R., Sekar K., Shukla V.K., Singh H.B., Singh P.K., Singh P., Singh R., Srinivasan N., Varma D.S., Viramgami A., Wilson V.C., Yadav S., Yadav S., Zaman K., Chakrabarti A., Das A., Dhaliwal R.S., Dutta S., Kant R., Khan A.M., Narain K., Narasimhaiah S., Padmapriyadarshini C., Pandey K., Pati S., Patil S., Rajkumar H., Ramarao T., Sharma Y.K., Singh S., Panda S., Reddy D.C, & Bhargava B. (2021). SARS-CoV-2 seroprevalence among the general population and healthcare workers in India, December 2020–January 2021. International Journal of Infectious Diseases, 108, 145-155.

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SARS-CoV-2 Detection in Conjunctival and Throat Swabs

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Real-time RT-PCR tests for SARS-CoV2 nucleic acid were performed on conjunctival and throat swabs using either Allplex SARS-CoV-2 PCR (CFX96 instrument) or Abbott SARS-CoV-2 PCR (m2000 instrument) in accordance with the manufacturers’ instructions.13 14 A positive result was confirmed using Cepheid Xpert Xpress SARS-CoV-2.15 After collection, the swabs were promptly transported to the local laboratory and stored in a refrigerator at +5°C (temperature limits +2 to +8) until analysed.
Serological testing was conducted using the Abbott SARS-CoV-2 IgG assay (ARCHITECT instrument), a chemiluminescent microparticle immunoassay used for the qualitative detection of antibodies towards the nucleocapsid protein of SARS-CoV-2 (sensitivity 100%, specificity 99.6%).16 17 All positive tests were then confirmed by using the Euroimmune Anti-SARS-CoV-2 Assay, an ELISA for the detection of IgG against the SARS-CoV-2 spike protein.
Data are presented with descriptive statistics (IBM SPSS Statistics, V.25.0 IBM Corp).
Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research.

Granstam E., Krifors A., Freyhult E, & Åkerblom H. (2021). No findings of SARS-CoV-2 in conjunctival swabs from patients at an emergency outpatient ophthalmological healthcare facility in a Swedish county hospital: a cross-sectional study. BMJ Open Ophthalmology, 6(1), e000616.

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Quantifying Humoral Immune Responses to SARS-CoV-2 Vaccination

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Humoral immune responses to vaccination were measured with a quantitative assay directed against the SARS CoV-2 Spike (S) protein (Liaison SARS CoV-2 TrimericS IgG assay, DiaSorin, Italy), with a lower limit of detection of 4.81 BAU/ml. The assay was performed following the manufacturer's instructions. Values >= 10 BAU/ml were considered reactive and values of >= 300 BAU/ml were shown to correlate with presence of neutralizing antibodies, based on in-house validation studies and harmonization between serological methods used in collaborative study teams.³¹ Antibodies against the viral Nucleocapsid protein (N) were measured on an Abbott Architect instrument using the Abbott SARS-CoV-2 IgG assay following the manufacturer's instructions.³² Qualitative results and index values were used for analysis, with the cut-off for positive set at 1.4 S/CO.

Hoek R.A., Verschuuren E.A., de Vries R.D., Vonk J.M., van Baarle D., van der Heiden M., van Gemert J.P., Gore E.J., Niesters H.G., Erasmus M., Hellemons M.E., Scherbeijn S.M., Wijbenga N., Mahtab E.A., GeurtsvanKessel C.H, & Buter C.V. (2022). High torque tenovirus (TTV) load before first vaccine dose is associated with poor serological response to COVID-19 vaccination in lung transplant recipients. The Journal of Heart and Lung Transplantation, 41(6), 765-772.

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Seroprevalence of COVID-19 Antibodies

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Eligible participants were interviewed to collect information about sociodemographic details, symptoms suggestive of COVID-19 since March 1, 2020 (eg, fever, cough, shortness of breath, sore throat, new loss of taste or smell, fatigue), exposure history to laboratory-confirmed COVID-19 cases, and history of COVID-19 illness using the Open Data Kit mobile phone application. 3–5 mL of venous blood was collected from each participant, and centrifuged serum samples were transported to ICMR National Institute of Epidemiology, Chennai under cold chain.
Participant serum samples were tested for the presence of SARS-CoV-2 specific IgG antibodies on the Abbott Architect i2000SR automated analyser using the Abbott SARS-CoV-2 IgG assay (Abbott Park, IL, USA) as per the manufacturer's instructions. This assay detects IgG antibodies against the SARS-CoV-2 nucleocapsid protein, and has a sensitivity of 100·0% and specificity of 99·6%.⁵ The assay was calibrated with positive and negative quality controls before analyses. Assay results higher than or equal to the cutoff index value of 1·4 were interpreted as positive for SARS-CoV-2 antibodies. As a part of quality control, 10% of positive serum samples and an equal number of negative serum samples were re-tested using the same assay.

Murhekar M.V., Bhatnagar T., Selvaraju S., Saravanakumar V., Thangaraj J.W., Shah N., Kumar M.S., Rade K., Sabarinathan R., Asthana S., Balachandar R., Bangar S.D., Bansal A.K., Bhat J., Chopra V., Das D., Deb A.K., Devi K.R., Dwivedi G.R., Khan S.M., Kumar C.P., Kumar M.S., Laxmaiah A., Madhukar M., Mahapatra A., Mohanty S.S., Rangaraju C., Turuk A., Baradwaj D.K., Chahal A.S., Debnath F., Haq I., Kalliath A., Kanungo S., Kshatri J.S., Lakshmi G.G., Mitra A., Nirmala A.R., Prasad G.V., Qurieshi M.A., Sahay S., Sangwan R.K., Sekar K., Shukla V.K., Singh P.K., Singh P., Singh R., Varma D.S., Viramgami A., Panda S., Reddy D.C, & Bhargava B. (2021). SARS-CoV-2 antibody seroprevalence in India, August–September, 2020: findings from the second nationwide household serosurvey. The Lancet. Global Health, 9(3), e257-e266.

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SARS-CoV-2 IgG Antibody Detection

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Serum samples underwent testing for the presence of SARS-CoV-2 IgG antibodies targeting the receptor binding domain (RBD) of the spike (S) protein and the nucleocapsid (NP) protein using the Abbott SARS-CoV-2 IgG assay (Abbott, Park, IL, USA) on the Abbott Architect i2000SR automated analyzer according to the manufacturer’s instructions. Results were interpreted as positive when higher than or equal to the cut-off index value of 50 AU for the anti-S and 1.4 AU for the anti-NP IgG antibody titer.

Riccomi A., Trombetta C.M., Dorrucci M., Di Placido D., Sanarico N., Farchi F., Giuseppetti R., Villano U., Marcantonio C., Marchi S., Ciaramella A., Pezzotti P., Montomoli E., Valdarchi C., Ciccaglione A.R, & Vendetti S. (2024). Effects of Influenza Vaccine on the Immune Responses to SARS-CoV-2 Vaccination. Vaccines, 12(4), 425.

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Detection of SARS-CoV-2 IgG Antibodies

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Detection of IgG antibody to SARS-CoV-2 N antigen was performed with the EUA approved Abbott SARS-CoV-2 IgG assay (Abbott Laboratories) on the Abbott Architect i2000SR immunoassay analyzer as previously described.²³

Lopez C.A., Cunningham C.H., Pugh S., Brandt K., Vanna U.P., Delacruz M.J., Guerra Q., Goldstein S.J., Hou Y.J., Gearhart M., Wiethorn C., Pope C., Amditis C., Pruitt K., Newberry-Dillon C., Schmitz J., Premkumar L., Adimora A.A., Emch M., Boyce R., Aiello A.E., Fosdick B.K., Larremore D.B., de Silva A.M., Juliano J.J, & Markmann A.J. (2021). Disparities in SARS-CoV-2 seroprevalence among individuals presenting for care in central North Carolina over a six-month period. medRxiv.

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SARS-CoV-2 Antibody Testing in Healthcare Workers

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Blood samples were sent immediately to the virology department of each participating hospital and centrifuged, and EDTA plasma was frozen at − 20 °C until tested by batch in the Pitié-Salpêtrière virology laboratory. Plasma samples were analyzed on the Abbott Architect platform with the Abbott SARS-CoV-2 IgG assay, targeting the viral nucleoprotein^{8 (link)}. Results were interpreted as recommended by the manufacturer: an index value < 0.5 was considered negative, 0.5–1.4 weak positive, and ≥ 1.4 positive. When SARS-CoV-2 infection was suspected in an HCW during the study period, the COVID-19 diagnosis was established by RT-PCR on a nasopharyngeal swab with the Cobas SARS-CoV-2 kit (Roche Diagnostics) or RealStar SARS-CoV-2 RT-PCR kit (Altona), as previously reported^{9 (link)}.

Hausfater P., Boutolleau D., Lacombe K., Beurton A., Dumont M., Constantin J.M., Ghosn J., Combes A., Cury N., Guedj R., Djibré M., Bompard R., Mazerand S., Pourcher V., Gimeno L., Marois C., Teyssou E., Marcelin A.G., Hajage D, & Tubach F. (2022). Cumulative incidence of SARS-CoV-2 infection and associated risk factors among frontline health care workers in Paris: the SEROCOV cohort study. Scientific Reports, 12, 7211.

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SARS-CoV-2 IgG Antibody Detection Assay

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Serum samples were processed on the Abbott ARCHITECT instrument using the Abbott SARS-CoV-2 IgG assay following manufacturer’s instructions (SARS-CoV-2 IgG for use with ARCHITECT; Abbott Laboratories, Abbott Park, IL, USA) [22 ]. Although not independently validated, the Abbott IgG test runs on the ARCHITECT platform with the approval of the Ethiopian Food and Drug Administration. The assay is a chemiluminescent micro-particle immunoassay for qualitative detection of IgG in human serum or plasma against the SARS-CoV-2 nucleoprotein. The IgG antibodies to SARS-CoV-2 in each sample were determined by comparing the chemiluminescent relative light unit (RLU) in the samples to the calibrator RLU. Samples were deemed positive if the index values are above the manufacturer’s recommended cut off value of 1.40. Using an index signal cut-off (S/C) threshold of 1.4, the manufacturer reported a sensitivity of 86.4% after 7 days from symptom onset and 100% after 14 days, and a specificity of 99.6%, using RT-PCR as the gold standard. The algorithm has sensitivity of 0 for infections with symptom onset of less than 3 days [11 ].

Shaweno T., Abdulhamid I., Bezabih L., Teshome D., Derese B., Tafesse H, & Shaweno D. (2021). Seroprevalence of SARS-CoV-2 antibody among individuals aged above 15 years and residing in congregate settings in Dire Dawa city administration, Ethiopia. Tropical Medicine and Health, 49, 55.

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SARS-CoV-2 Antibody Detection Assay

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The Abbott SARS-CoV-2 IgG assay (Abbott Architect, Abbott Laboratories, Abbott Park, IL), which detects IgG against SARS-CoV-2 N protein, was performed on the Architect i2000sr platform according to the manufacturer’s instructions. Specimens were thawed on the day of testing and were centrifuged at 10,000 × g for 10 min prior to each run. A sample-to-stored calibrator index (S/C) cutoff value of 1.4 was used for positive results, according to the manufacturer’s recommendations.

Yansouni C.P., Papenburg J., Cheng M.P., Corsini R., Caya C., Vasquez Camargo F., Harrison L.B., Zaharatos G., Büscher P., Faye B., Ndiaye M., Matlashewski G, & Ndao M. (2022). Specificity of SARS-CoV-2 Antibody Detection Assays against S and N Proteins among Pre-COVID-19 Sera from Patients with Protozoan and Helminth Parasitic Infections. Journal of Clinical Microbiology, 60(1), e01717-21.

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