Elecsys anti sars cov 2 kit

Manufactured by Roche

Sourced in China, United States, Switzerland

The Elecsys® Anti-SARS-CoV-2 kit is an in vitro diagnostic test used for the detection of antibodies to SARS-CoV-2 in human serum and plasma samples. The test is based on an electrochemiluminescence immunoassay (ECLIA) technology.

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Lab products found in correlation

Elecsys anti sars cov 2 s kit, by Roche (2 mentions) Sars cov 2 igg elisa kit, by EUROIMMUN (1 mentions) Architect i system, by Abbott (1 mentions) Cobas e602 analyzer, by Roche (1 mentions) Elecsys anti sars cov 2 immunoassay, by Roche (1 mentions) Cobas e411 analyzer, by Roche (1 mentions)

12 protocols using elecsys anti sars cov 2 kit

Comparative Evaluation of SARS-CoV-2 Antibody Assays

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Five serological tests were performed in all three rounds. Characteristics of the tests are provided in Supplementary Table S1. Two of the tests detected antibodies recognizing the S-antigen, one recognized the 2019-nCoV recombinant antigen and two tests recognized the N-antigen of SARS-CoV-2. Detection of SARS-CoV-2 IgG antibodies was performed with five different quantification methods, of which two were enzyme-linked immunosorbent assays (ELISA) and three were chemiluminescence-based immunoassays (CLIA/CMIA). All tests were carried out according to manufacturers’ instructions. For detailed information on assay characteristics and instruments used, see Supplementary Table S1. Sensitivities and specificities are shown as provided by the manufacturer. The following assays were used; EDI Novel Coronavirus SARS-CoV-2 IgG ELISA kit (Epitope Diagnostics Inc., San Diego, CA, USA), SARS-CoV-2 IgG ELISA kit (Euroimmun, Lübeck, Germany), SARS-CoV-2 S1/S2 IgG CLIA kit (DiaSorin, Saluggia, Italy), 2019-nCoV IgG kit (Snibe Co., Ltd., Shenzhen, China) and Elecsys Anti–SARS-CoV-2 kit (Roche, Basel, Switzerland).

Schnizer C., Andreas N., Vivas W., Kamradt T., Baier M., Kiehntopf M., Glöckner S., Scherag A., Löffler B., Kolanos S., Guerra J., Pletz M.W, & Weis S. (2023). Persistent humoral and CD4+ TH cell immunity after mild SARS-COV-2 infection—The CoNAN long-term study. Frontiers in Immunology, 13, 1095129.

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Electrochemiluminescence Assay for Anti-SARS-CoV-2 Antibody Titer

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Electrochemiluminescence immunoassay was performed for determination of anti-SARS-CoV-2 antibody titer using Elecsys^® Anti-SARS-CoV-2 kit (Roche Diagnostics, Basel, Switzerland). The assay is based on the double antigen principle, whereby biotinylated SARS-CoV-2-specific recombinant nucleocapsid antigen and ruthenium-labelled SARS-CoV-2-specific recombinant antigen form a sandwich complex with SARS-CoV-2-specific antibodies. Blood of plasma donor was collected in an acid citrate dextrose vial and centrifuged to collect plasma. The tube containing 1–2 ml plasma was placed in automated electrochemiluminescence analyzer (Cobas e601) for reagent mixing, reaction processing and signal recording. For C-IVIG anti-SARS-CoV-2, antibodies were measured using a 1:4 dilution to avoid any assay limitation. Results were reported as cut-off index (COI), which is based on the ratio of assay signal to cut-off signal (cut-off = 1).

Ali S., Uddin S.M., Ali A., Anjum F., Ali R., Shalim E., Khan M., Ahmed I., M Muhaymin S., Bukhari U., Luxmi S., Khan A.S, & Quraishy S. (2021). Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma. Immunotherapy.

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SARS-CoV-2 Antibody Detection Using Elecsys Assay

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The detection of SARS-CoV-2 antibodies was carried out using the Elecsys® Anti-SARS-CoV-2 kit (antibodies IgG and IgM) (Roche Diagnostics, Mannheim, Germany). Briefly, it is an automated sandwich, double-antigen electrochemiluminescent immunoassay that employs recombinant protein representing the nucleocapsid antigen of the virus, using Cobas e801 equipment following the manufacturer's instructions. As indicated by the manufacturer, samples with a DO/Cut-Off result >1.0 were considered positive. The validation and performance of the kit are well-established 24 (link), 25 (link), 26 (link). Elecsys® Anti-SARS-CoV-2 kit detects total antibodies and does not differentiate the antibody classes (IgG, IgM, or IgA).

Moya Rios do Vale N., Roche Moreira Latini F., Prisco Arnoni C., Martins Parreira R., Batista Castelo Girão M.J., Pereira Cortez A.J, & Carvalho de Souza Bonetti T. (2022). Increasing rate of anti-SARS-CoV-2 antibodies between the first and second waves of COVID-19 in São Paulo, Brazil: A cross-sectional blood donors-based study. Clinics, 77, 100016.

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SARS-CoV-2 Antibody Measurement

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We measured total antibodies (including IgG) to the SARS-CoV-2 spike protein receptor binding domain (RBD) in the sera using a commercially available Elecsys^® Anti-SARS-CoV-2 S kit (Cat# 09 289 275 190, Roche), as recommended by the manufacturer. We also measured antibodies (including IgG) to the SARS-CoV-2 nucleocapsid (N) protein in the sera with a double-antigen sandwich assay format using Elecsys^® Anti-SARS-CoV-2 kit (Cat# 09 203 079 190, Roche), as recommended by the manufacturer.

Hung C.Y., Hsiao S.H., Huang C.G., Chang C.S., Chen G.Y., Huang Y.L., Dutta A, & Huang C.T. (2023). Relatively preserved functional immune capacity with standard COVID-19 vaccine regimen in people living with HIV. Frontiers in Immunology, 14, 1204314.

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Serum Anti-SARS-CoV-2 Antibody Detection

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Venous blood (3 mL) collected by venipuncture under aseptic conditions in clot activator vials wearing personal protective equipment (PPE) was transferred to the clinical biochemistry lab and centrifuged at 3000 rpm for 10 min. Separated serum was used for the analysis of anti-SARS-CoV-2 on Roche Cobas 6000 autoanalyzer based on electrochemiluminescence Immunoassay (ECLIA) using Roche Elecsys anti-SARS-CoV-2 kit (Catalogue no- 09203095190). The data were analyzed in terms of the cut off index (COI) calculated automatically by autoanalyzer based on calibrators- ACOV Cal1 and ACOV Cal2. Subjects were categorized as anti-SARS-CoV-2 reactive and non-reactive based on COI value. COI ≥ 1 was considered reactive, interpreted as positive, and COI < 1 was considered non-reactive, interpreted as negative as per manufacturer’s instructions.

Chidananda M.K., Zohmangaihi D., Ram S., Soni S.L., Suri V., Malhotra P., Jassal R.S., Kaur J., Verma I, & Sharma S. (2021). Combined Analysis of Anti SARS-CoV-2 IgG and IgM Responses in COVID19 Patients in India. Indian Journal of Clinical Biochemistry, 36(4), 485-491.

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Serological Assays for SARS-CoV-2 Antibodies

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Qualitative detection of serum antibodies to SARS-CoV-2 was performed using the Elecsys® Anti-SARS-CoV-2 kit (Roche Diagnostics) and reported as positive or negative serology. This assay uses a recombinant protein representing the nucleocapsid antigen in a double-antigen sandwich assay format, which favors detection of high-affinity antibodies against SARS-CoV-2.
A SARS-CoV-2 IgG assay was performed using the ARCHITECT i System (Abbott Diagnostics) to detect immunoglobulin class G (IgG) antibodies to the nucleocapsid protein of SARS-CoV-2 in serum from patients. The results of this testing were used for the sensitivity and specificity analyses.

Almaghrabi R.S., Alsagheir O.I., Alquaiz R.M., Alhekail O.Z., Abaalkhail A.M., Alduaij A.A., Algwaiz G.F., Alkaff M.A, & Althawadi S.I. (2021). Seroprevalence of SARS-CoV-2 antibodies in healthcare workers at a tertiary care hospital in Riyadh, Saudi Arabia. IJID Regions, 2, 51-54.

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Correlation of Neutralization and Anti-N Antibodies

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To analyze the correlation between neutralization activity and anti-SARS-CoV-2 nucleocapsid antibody titers, Elecsys^® Anti-SARS-CoV-2 kit (Roche Diagnostics) was used. A recombinant nucleocapsid protein was used to detect high-affinity antibodies against SARS-CoV-2 (Muench et al., 2020 (link)). A double-antigen sandwich principle was utilized, and the ECLIA method was applied using cobas immunoassay analyzers. The detectable isotypes included IgA and IgG, and a cut-off index (COI) ≥1.0 was considered positive (Roche, 2020b ). The kit was approved as a qualitative test, and the manufacturer did not suggest a titer correlation between the COI value and antibody titer. Nevertheless, the measured COI values were reported to be as high as 167 in the present analysis, and we investigated the correlation between COI values and the neutralizing titer of the study specimens.

Lee B., Ko J.H., Park J., Moon H.W., Baek J.Y., Jung S., Lim H.Y., Kim K.C., Huh K., Cho S.Y., Kang C.I., Chung D.R., Huh H.J., Chung C.R., Kim Y.J., Joo E.J., Kang E.S, & Peck K.R. (2022). Estimating the Neutralizing Effect and Titer Correlation of Semi-Quantitative Anti-SARS-CoV-2 Antibody Immunoassays. Frontiers in Cellular and Infection Microbiology, 12, 822599.

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SARS-CoV-2 Antibodies Detection Assay

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The qualitative detection of SARS-CoV-2 antibodies in human serum was performed on the Cobas e602 analyzer using Elecsys anti-SARS-CoV-2 kit (Roche Diagnostics). This electrochemiluminescent immunoassay (ECLIA) using recombinant nucleocapsid antigens allows the detection of total anti-SARS-CoV-2 antibodies with a sensitivity of 100% and specificity of 95%. According to the manufacturer's instructions, a result was considered positive if the index was ≥ 1.00.

Scohy A., Gruson D., Simon A., Kabamba-Mukadi B., De Greef J., Belkhir L., Rodriguez-Villalobos H., Robert A, & Yombi J.C. (2021). Seroprevalence of SARS-CoV-2 infection in health care workers of a teaching hospital in Belgium: self-reported occupational and household risk factors for seropositivity. Diagnostic Microbiology and Infectious Disease, 100(4), 115414.

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Quantification of Anti-SARS-CoV-2 Antibodies

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The three batches of equine anti-SARS-CoV-2 F(ab′)₂ immunoglobulin were diluted in sterile pyrogenic saline solution at a ratio of 2 from 1/20 to 1/20,480. The samples were transferred to collection tubes of the vacutainer type compatible with Cobas and Roche equipment. The analyses were performed in an automated manner using the Elecsys^® Anti-SARS-CoV-2 kit (Roche Diagnostics International AG) for the quantitative determination of antibodies (including IgG) against the RBD domain of the SARS-CoV-2 spike protein. The results are reported as U/mL based on the kit's standard monoclonal antibody curve.

Botosso V.F., Jorge S.A., Astray R.M., de Sá Guimarães A.M., Mathor M.B., de Carneiro P.D., Durigon E.L., Covas D., de Oliveira D.B., das Neves Oliveira R., Maria D.A., Eto S.F., Gallina N.M., Pidde G., Squaiella-Baptistão C.C., Silva D.T., Villas-Boas I.M., Fernandes D.C., Auada A.V., Banari A.C., de Souza Filho A.F., Bianconi C., de Agostini Utescher C.L., Oliveira D.C., Mariano D.O., Barbosa F.F., Rondon G., Kapronezai J., da Silva J.G., Goldfeder M.B., Comone P., Junior R.E., Pereira T.T., Wen F.H., Tambourgi D.V, & Chudzinski-Tavassi A.M. (2022). Anti-SARS-CoV-2 equine F (Ab′)2 immunoglobulin as a possible therapy for COVID-19. Scientific Reports, 12, 3890.

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Detection of Anti-SARS-CoV-2 NP Antibodies

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To detect anti-SARS-CoV-2 NP antibody induced by past SARS-CoV-2 infection, an Elecsys^® Anti-SARS-CoV-2 kit (Roche Diagnostics) was used. The double-antigen sandwich principle was used, and the ECLIA method was applied with Cobas e modules. The detectable isotypes included IgA and IgG, and a cut-off index greater than or equal to 1.0 was considered positive (31 ).

Nham E., Ko J.H., Song K.H., Choi J.Y., Kim E.S., Kim H.J., Kim B., Lim H.Y., Kim K.C., Jang H.C., Lee K.H., Song Y.G., Baek Y.J., Ahn J.Y., Choi J.Y., Kim Y.C., Park Y.S., Choi W.S., Bae S., Kim S.H., Kang E.S., Jeong H.W., Kim S.W., Kwon K.T., Kim S.S, & Peck K.R. (2022). Kinetics of vaccine-induced neutralizing antibody titers and estimated protective immunity against wild-type SARS-CoV-2 and the Delta variant: A prospective nationwide cohort study comparing three COVID-19 vaccination protocols in South Korea. Frontiers in Immunology, 13, 968105.

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