Anti sars cov 2 immunoassay

Manufactured by Roche

Sourced in Switzerland

The Anti-SARS-CoV-2 immunoassay is a laboratory testing product designed to detect the presence of antibodies against the SARS-CoV-2 virus, the causative agent of COVID-19. The assay utilizes immunological techniques to identify specific antibodies in patient samples, providing information about an individual's immune response to the virus.

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Lab products found in correlation

Human ab serum, by Innovative Research (1 mentions) Donkey anti rabbit igg secondary antibody, by Jackson ImmunoResearch (1 mentions) Versamax, by Molecular Devices (1 mentions) Cobas e411 analyzer, by Roche (1 mentions) Elecsys anti sars cov 2 s immunoassay, by Roche (1 mentions) Cobas 8000 e602 analyzer, by Roche (1 mentions)

6 protocols using anti sars cov 2 immunoassay

Serological Assays for SARS-CoV-2 Antibodies

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RBD IgG ELISAs were performed using a previously published protocol (47 (link)), except that plasma was diluted to a final concentration of 1:20. Human AB serum (Innovative Research) purchased before the COVID-19 pandemic was used as a negative control, and a commercially available rabbit anti-SARS-CoV-2 spike monoclonal antibody (catalog number 40150-R0907, Sino Biological) and donkey anti-rabbit IgG secondary antibody (Jackson ImmunoResearch) were used as a positive control. The plates were read in a VersaMax tunable microplate reader (Molecular Devices). The average of the negative control readings plus 3 times the standard deviation was used as a cut-off for positivity.
N IgG ELISAs were performed using the Elecsys Anti-SARS-CoV-2 immunoassay (Roche) on a Cobas e411 analyzer (Roche) per the manufacturer’s instructions (48 (link)). A COI value >1 was considered positive.

Lesteberg K.E., Araya P., Waugh K.A., Chauhan L., Espinosa J.M, & Beckham J.D. (2023). Severely ill and high-risk COVID-19 patients exhibit increased peripheral circulation of CD62L+ and perforin+ T cells. Frontiers in Immunology, 14, 1113932.

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Quantifying SARS-CoV-2 Antibodies

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We measured serum anti-S antibodies using the Elecsys Anti-SARS-CoV-2 S Immunoassay (hereafter abbreviated as Elecsys Anti-S) and anti-N antibodies using the Elecsys Anti-SARS-CoV-2 Immunoassay (hereafter abbreviated as Elecsys Anti-N) (Roche Diagnostics International Ltd., Rotkreuz, Switzerland) on a fully automated Roche Cobas 8000 e602 analyzer. According to the manufacturer’s instructions, anti-S antibody values >0.8 U/mL and anti-N antibody values >1.0 U/mL were considered positive.

Seo Y.J., Oh I., Nam M., Shin S., Roh E.Y, & Song E.Y. (2023). Comparison of Four T-cell Assays and Two Binding Antibody Assays in SARS-CoV-2 Vaccinees With or Without Omicron Breakthrough Infection. Annals of Laboratory Medicine, 43(6), 596-604.

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Characterization of SARS-CoV-2 Antibodies

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We assessed SARS-CoV-2 specific antibodies against the spike and nucleocapsid proteins using Sensitive Anti-SARS-CoV-2 Spike Trimer Immunoglobulin Serological (SenASTrIS), a Luminex binding assay.²¹ (link) The assay measures binding of IgG antibodies to the trimeric SARS-CoV-2 spike and the nucleocapsid proteins. The test has a high specificity (99%) and sensitivity (97%), has been validated in samples of the general population and in specific subgroups²¹ (link) and results in semi-quantitative median fluorescence intensity (MFI) values. The MFI values have additionally been translated to the WHO units per millilitre (U/mL) scale as measured by the Elecsys Anti-SARS-CoV-2 immunoassay by Roche.¹² (link) We also assessed the presence of SARS-CoV-2 neutralizing antibodies against three variants (ancestral strain, Delta and Omicron) that were dominant in Switzerland in 2022, using a cell- and virus-free assay.²⁴ (link) This assay measures the proportion of antibodies that block the interaction of the angiotensin-converting enzyme 2 receptor (ACE2r) with the receptor-binding domain of the trimer spike protein of the ancestral strain and variants of concern. All analyses were performed in the laboratory of Immunology of the Lausanne University Hospital (CHUV).

Frei A., Kaufmann M., Amati R., Butty Dettwiler A., von Wyl V., Annoni A.M., Vincentini J., Pellaton C., Pantaleo G., Fehr J.S., D'Acremont V., Bochud M., Albanese E, & Puhan M.A. (2023). Development of hybrid immunity during a period of high incidence of Omicron infections. International Journal of Epidemiology, 52(6), 1696-1707.

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COVID-19 Antibody Validation Study

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All samples were collected prior to December 2020 making it highly unlikely that these were from vaccinated patients as vaccines were only available within clinical trials at this point. Stored serum samples from 25 COVID-19 antibody positive patients and 25 COVID-19 antibody negative patients selected at random were provided by the Virology department. All samples were anonymised by the Virology department and given subsequent identifying numbers (1–50), these samples were used to complete all validation testing and results of this study were not used in patient management. Samples were stored at -40 °C prior to testing.
For the purpose of this study sample selection was based upon COVID-19 antibody status previously determined by the Roche Elecsys Anti-SARS-CoV-2 immunoassay by the Virology department. This is a qualitative assay that detects IgG/IgM antibodies against a recombinant protein representing the SARS-CoV-2 nucleocapsid antigen (N). Results of this test reported by virology were considered either antibody negative if the cut-off index (COI) <1.0 or antibody positive if the COI ≥1.0.

Cox A., Stevens M., Kallon D., Gupta A, & White E. (2023). Comparative evaluation of Luminex based assays for detection of SARS-CoV-2 antibodies in a transplantation laboratory. Journal of Immunological Methods, 517, 113472.

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Quantifying Anti-SARS-CoV-2 Antibodies

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20 mL of blood in serum separator tubes (SST) were obtained at enrollment, and at 6 and 12 months following the last COVID-19 vaccination dose received. The blood was processed for serum separation, aliquots made, and stored at −20 °C until shipment to WRAIR or the Tasso Care laboratory for testing using the Elecsys Anti-SARS-CoV-2 immunoassay for the qualitative detection of antibodies against SARS-CoV-2 (Roche, cat. no. 09203095190) and was done according to the manufacturer’s instructions.

Gromowski G.D., Cincotta C.M., Mayer S., King J., Swafford I., McCracken M.K., Coleman D., Enoch J., Storme C., Darden J., Peel S., Epperson D., McKee K., Currier J.R., Okulicz J., Paquin-Proulx D., Cowden J, & Peachman K. (2023). Humoral immune responses associated with control of SARS-CoV-2 breakthrough infections in a vaccinated US military population. eBioMedicine, 94, 104683.

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Self-Collected Blood Samples for Anti-SARS-CoV-2 Antibody

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Two Tasso SSTs (2 × 300 μl) per time-point and total volume of 600 μl of blood samples were self-collected by study subjects every month using a Tasso self-collection system (Tasso SST and/or Tasso+ device) according to the manufacturer’s instructions (https://www.tassoinc.com/). The samples were shipped according to kit instructions to the Tasso Care laboratory and were tested using the Elecsys Anti-SARS-CoV-2 immunoassay (Roche, cat. no. 09203095190) according to the manufacturer’s instructions.

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