Sars cov 2 total assay

Manufactured by Siemens

Sourced in Germany

The SARS-CoV-2 Total Assay is a laboratory equipment product developed by Siemens. It is designed to detect the presence of SARS-CoV-2, the virus that causes COVID-19, in patient samples. The assay utilizes advanced technology to provide accurate and reliable results for the identification of the virus.

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Lab products found in correlation

Elecsys anti sars cov 2 assay, by Roche (4 mentions) Luminex 200 device, by DiaSorin (1 mentions)

7 protocols using sars cov 2 total assay

SARS-CoV-2 IgG Antibody Detection

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SARS-CoV-2 Total Assay (Siemens, Eschborn, Germany) was used to determine IgG response against the S1 protein. The result is expressed as a dimensionless index, a semi-quantitative index <1 was classified as negative, a value of ≥1 as positive. The cut-off value was set three standard deviations above the mean of the negatives, according to the manufacturer. The defined cutoff gives a specificity of 100% and a sensitivity of 89% for the detection of anti-S1 antibodies.

Benning L., Töllner M., Hidmark A., Schaier M., Nusshag C., Kälble F., Reichel P., Buylaert M., Grenz J., Ponath G., Klein K., Zeier M., Süsal C., Schnitzler P., Morath C, & Speer C. (2021). Heterologous ChAdOx1 nCoV-19/BNT162b2 Prime-Boost Vaccination Induces Strong Humoral Responses among Health Care Workers. Vaccines, 9(8), 857.

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SARS-CoV-2 Antibody Detection Assays

Cited 3 times

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We used the SARS-CoV-2 Total Assay (Siemens) and the Elecsys anti-SARS-CoV-2 assay (Roche) to detect anti-S1 IgG and anti-nucleocapsid antibodies, respectively. A semi-quantitative index of ≥1 defines positivity for both assays.
Surrogate neutralizing antibodies were detected using a surrogate virus neutralization test (Medac) that mimics the virus interaction with the host cell by direct protein-protein interaction using purified RBD protein from the viral spike and the ACE-2 host cell receptor.²¹ (link)An inhibition ≥30% of RBD:ACE-2 binding defines positivity for this assay.
A bead-based multiplex assay for the Luminex platform (LabScreen Covid Plus, One Lambda Inc.) was used to detect IgG antibodies against four different SARS-CoV-2 target epitopes and IgG antibodies against the spike S1 of four common cold coronaviruses.²² (link)The mean fluorescence intensity (MFI) was analyzed using a Luminex 200 device (Luminex Corporation).
All assays were performed according to the manufacturer’s instructions and as described previously.²⁰ (link)
^,23 (link), 24 (link), 25 (link), 26 (link), 27 (link), 28 (link), 29 (link)

Benning L., Morath C., Bartenschlager M., Kim H., Reineke M., Beimler J., Buylaert M., Nusshag C., Kälble F., Reichel P., Töllner M., Schaier M., Klein K., Benes V., Rausch T., Rieger S., Stich M., Tönshoff B., Weidner N., Schnitzler P., Zeier M., Süsal C., Hien Tran T., Bartenschlager R, & Speer C. (2022). Neutralizing antibody response against the B.1.617.2 (delta) and the B.1.1.529 (omicron) variants after a third mRNA SARS-CoV-2 vaccine dose in kidney transplant recipients. American Journal of Transplantation, 22(7), 1873-1883.

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Evaluation of SARS-CoV-2 Antibody Assays

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The Elecsys anti–SARS-CoV-2 assay (Roche Diagnostics) uses recombinant biotinylated and ruthenium-labeled nucleocapsid protein in an electrochemiluminescent immunoassay.²⁷ Streptavidin-captured antigen-antibody complexes provide chemiluminescent signal after electrical stimulation. No manufacturer controls were available; pooled negative serum samples and a known strongly positive sample diluted in negative serum samples were used as negative and positive quality control (QC) material, respectively, with aliquots frozen for daily QC.
The SARS-CoV-2 Total assay (Siemens) uses recombinant S1 subunit receptor-binding domain (RBD) as biotinylated and acridinium ester-conjugated antigens for a chemiluminescent immunoassay.²⁸ Streptavidin-captured sandwich complexes generate light after excitation. Testing was bracketed by daily cleaning procedures. The output spans an index value of 0.05 to 10.00.

Manthei D.M., Whalen J.F., Schroeder L.F., Sinay A.M., Li S.H., Valdez R., Giacherio D.A, & Gherasim C. (2020). Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples. American Journal of Clinical Pathology, 155(2), 267-279.

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Serological Assays for COVID-19 IgG

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We used the SARS-CoV-2 Total Assay (Siemens, Eschborn, Germany) to measure the IgG response against the S1 protein with a semi-quantitative index ≥1 defining positivity. This cut-off for detection gives a specificity of 100% with a sensitivity of 89%. IgG against the nucleocapsid protein was measured by the semiquantitative Elecsys anti-SARS-CoV-2 assay (Roche, Mannheim, Germany). Assays were performed according to the manufacturers' instructions.

Benning L., Morath C., Bartenschlager M., Reineke M., Töllner M., Nusshag C., Kälble F., Reichel P., Schaier M., Klein K., Schnitzler P., Zeier M., Süsal C., Bartenschlager R, & Speer C. (2022). Neutralizing antibody activity against the B.1.617.2 (delta) variant 8 months after two-dose vaccination with BNT162b2 in health care workers. Clinical Microbiology and Infection, 28(7), 1024.e7-1024.e12.

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Comprehensive Immune Response Evaluation After COVID-19 Vaccination

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Patient/disease characteristics, infection history, complete blood counts, immunoglobulins, and T-cell subsets were collected at baseline. Vaccine-specific serologies were collected before vaccination and 36 days after vaccination (median, 32 days; interquartile range, 27-35). S pneumoniae serologies were measured with the 23-serotype IgG assay. COVID-19 serologies were measured with a quantitative electrochemiluminescence immunoassay for detecting antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD immunoassay; Roche Elecsys) and a qualitative electrochemiluminescence immunoassay for detecting antibodies to SARS-CoV-2 nucleocapsid antibody (N-immunoassay; Roche Elecsys). Due to logistical constraints in 2 cases, post–COVID-19 vaccine spike serologies were measured with the DiaSorin Liaison SARS-CoV-2 S1/S2 IgG assay (n = 1) or the Siemens SARS-CoV-2 total assay (n = 1).

Haydu J.E., Maron J.S., Redd R.A., Gallagher K.M., Fischinger S., Barnes J.A., Hochberg E.P., Johnson P.C., Takvorian R.W., Katsis K., Portman D., Ruiters J., Sechio S., Devlin M., Regan C., Blumenthal K.G., Banerji A., Judd A.D., Scorsune K.J., McGree B.M., Sherburne M.M., Lynch J.M., Weitzman J.I., Lei M., Kotton C.N., Dighe A.S., Maus M.V., Alter G., Abramson J.S, & Soumerai J.D. (2022). Humoral and cellular immunogenicity of SARS-CoV-2 vaccines in chronic lymphocytic leukemia: a prospective cohort study. Blood Advances, 6(6), 1671-1683.

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Quantifying SARS-CoV-2 Antibody Titers

Cited 1 time

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Anti-spike S1 IgG antibodies were measured using the SARS-CoV-2 Total Assay (Siemens, Eschborn, German). Results of this assay are obtained in as little as 10 minutes on the Atellica IM Analyzer with a capacity to process up to 440 assays per hour, dependent on test mix. Positivity is defined as a semi-quantitative index of ≥1, which gives a specificity of 100% and a sensitivity of 98% for the detection of anti-S1 IgG antibodies. The assay is called semi-quantitative as there is no scale basis for antibody testing for this assay. The clinical applicability of a semi-quantitative assay is currently unknown and cannot be transferred into a degree of immunity. A strong correlation for anti-S1 IgG as measured by the SARS-CoV-2 Total Assay to neutralization against SARS-CoV-2 wild-type or other SARS-CoV-2 variants of concern has been described previously (10 (link), 17 (link)–19 (link)). We further used the Elecsys anti-SARS-CoV-2 assay (Roche, Mannheim, Germany) to detect antibodies against the nucleocapsid protein. Assays were performed according to the manufacturers’ instructions.

Benning L., Klein K., Morath C., Bartenschlager M., Kim H., Buylaert M., Reineke M., Töllner M., Nusshag C., Kälble F., Reichel P., Schnitzler P., Zeier M., Süsal C., Bartenschlager R., Schaier M, & Speer C. (2022). Neutralizing Antibody Activity Against the B.1.617.2 (delta) Variant Before and After a Third BNT162b2 Vaccine Dose in Hemodialysis Patients. Frontiers in Immunology, 13, 840136.

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SARS-CoV-2 Antibody Detection Protocol

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Anti-spike S1 IgG antibodies were determined using the SARS-CoV-2 Total Assay (Siemens, Eschborn, German). Positivity was defined as a semi-quantitative index of ≥1, giving a specificity of 100% and a sensitivity of 100% for the detection of anti-S1 IgG antibodies. The Elecsys anti-SARS-CoV-2 assay (Roche, Mannheim, Germany) was performed to detect antibodies against the nucleocapsid protein and individuals with a positive result were excluded because of suspected recent SARS-CoV-2 infection. Both assays were performed according to the manufacturer’s instructions.

Speer C., Töllner M., Benning L., Bartenschlager M., Kim H., Nusshag C., Kälble F., Reineke M., Reichel P., Schnitzler P., Zeier M., Morath C., Schmitt W., Bergner R., Bartenschlager R., Lorenz H.M, & Schaier M. (2023). BA.1/BA.5 Immunogenicity, Reactogenicity, and Disease Activity after COVID-19 Vaccination in Patients with ANCA-Associated Vasculitis: A Prospective Observational Cohort Study. Viruses, 15(8), 1778.

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