SARS-CoV-2 Total Antibody Immunoassay

Long-term monitoring and pandemic management of COVID-19

High-throughput SARS-CoV-2 Total Antibody Assay

In the effort to contain the COVID-19 pandemic, serological testing to detect SARS-CoV-2 specific antibodies will be important in disease and community management.

Gentian has developed a turbidimetric SARS-CoV-2 Total Antibody Immunoassay in collaboration with the University in Tromsø (UiT). The quantitative antibody test captures the full immune response detecting antibodies targeting the S1-subunit with high sensitivity and specificity and is calibrated against the WHO international standard.

Increased testing capacity

Gentian brings SARS-CoV-2 serology testing to automated, open-access clinical chemistry platforms, increasing both the testing capacity (up to 2000 tests/hour) and the laboratory efficiency. Since the Gentian assay is platform agnostic it can be seamlessly integrated in daily laboratory routine without additional infrastructure or workflow cost. The test follows a standard testing protocol utilising existing logistic structure, from the routine blood test at the GP office to the clinical chemistry platforms with an assay time of only 10 minutes.

Following the antibody levels and immune status of the society

The Gentian assay provides a tool to achieve documented protection for individuals and society. It allows the tracking of the total antibody response targeting the S1 subunit, to assess the level of protection. It provides a powerful high-throughput test for community management of COVID-19 through long-term monitoring of natural and vaccine-related immune response.

SARS-CoV-2 antibody assay to follow the antibody levels and immune status of the society

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Technical details

Assay Performance
Sample type	Plasma, Serum
Assay type	PETIA
Format	Liquid reagents, ready to use
Security zone*	Up to 3000 BAU/mL
Measuring range*	50 - 1000 BAU/mL
Calibration stability*	4 weeks
Target Antigen	SARS-CoV-2 spike protein (S1-subunit)
Standardisation	Calibrated against the WHO IS for anti-SARS-CoV-2 IgG (NIBSC code 20/136)
Reference Range	< 10 BAU/mL: negative > 50 BAU/mL: positive
Diagnostic Sensitivity	98.0% (95% CI: 96.2%, 99.0%)
Diagnostic Specificity	99.0% (95% CI: 97.9%, 99.6%)

*Instrument dependent results achieved on BS240 during validation

For more details on SARS-CoV-2 Total Antibody products and prices please contact us at marketing@gentian.com

The Gentian SARS-CoV-2 Total Antibody Immunoassay is a Particle-Enhanced Turbidimetric Immunoassay (PETIA) for in vitro diagnostic testing of total antibodies targeting the S1-subunit of the SARS-CoV-2 spike protein of in human plasma and serum samples.

The assay can be applied on a wide range of clinical chemistry analysers and is rapidly performed in only 10 minutes.

For more details on Gentian SARS-CoV-2 Total Antibody Immunoassay products and prices please contact us at marketing@gentian.com

The Gentian SARS-CoV-2 Total Antibody Calibrator is standardised against the WHO International Standard for anti-SARS-CoV-2 IgG (NIBSC code 20/136).

Product no	Product	Content
1801	Gentian SARS-CoV-2 Total Antibody Reagent Kit	R1 25 mL + R2 4.5 mL
1819	Gentian SARS-CoV-2 Total Antibody Control Kit	2 x 0.5 mL
1851	Gentian SARS-CoV-2 Total Antibody Calibrator Kit	6 x 0.5 mL

For more details on Gentian SARS-CoV-2 Total Antibody products and prices please contact us at marketing@gentian.com

Aligned with the WHO 1^st International Standard

The Gentian SARS-CoV-2 Total Antibody Immunoassay is calibrated against the WHO International Standard for anti-SARS-CoV-2 antibody, enabling harmonisation and comparison of results across laboratories and serological assays. This allows scientists, health care workers and laboratories to directly compare results, minimising variation and calibration correction.

Turbidimetric test

Faster throughput

Open channel

Capture Total Ab Response

Target S1-subunit

First WHO International Standard

Contact us for more information

Let us know if you want more information about the assay or want to validate the assay in your laboratory.

Please send us an email to marketing@gentian.com or fill out the form to the right. Our Product Manager for SARS-CoV-2 Total Antibody Immunoassay will get in touch.

FAQ - Gentian SARS-CoV-2 Total Antibody Immunoassay?

Which antigen is the target of Gentian SARS-CoV-2 Total Antibody Immunoassay?

The Gentian SARS-CoV-2 Total Antibody Immunoassay will capture the antibody response to the S1-antigen of the SARS-CoV-2.

Will the assay capture the total antibody response?

The Gentian SARS-CoV-2 Total Antibody Immunoassay will capture the IgG, IgM and IgA antibody response.

Is the assay traceable to the WHO International Standard?

The Gentian SARS-CoV-2 Total Antibody Immunoassay is calibrated against the WHO 1^st International Standard Anti-SARS-CoV-2 Immunoglobulin WHO/BS/2020.2402.

Is the assay available on all clinical chemistry analysers?

The Gentian SARS-CoV-2 Total Antibody Immunoassay is an open channel assay and applicable to most major clinical analyser. Please contact marketing@gentian.com for more information on availability on the clinical analyser in your laboratory.

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