Bio-Rad’s serology immunoassay kit will help clinicians diagnose Covid-19 by analysing the immune response against SARS-CoV-2. Credit: CDC / Unsplash.

Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates

Follow the latest updates of the outbreak on our timeline.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Bio-Rad Laboratories is set to launch a blood-based immunoassay kit for the identification of antibodies to the SARS-CoV-2, the virus that causes Covid-19.

The company has established preliminary performance of the assay, which is currently being clinically evaluated in multiple hospitals to further confirm its performance.

Initial data has been collected on more than 700 samples and demonstrated the specificity of over 99%.

Bio-Rad Clinical Diagnostics Group executive vice-president and president Dara Wright said: “Using a serology test to support the diagnosis of Covid-19 and to screen populations can provide a more complete understanding of infection rates, as well as immunity.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard.”

Viral antigens stimulate the immune system of the body to produce antibodies to fight the virus in case of SARS-CoV-2 infection.

Bio-Rad noted that its serology immunoassay kit will help clinicians diagnose Covid-19 by analysing the immune response against SARS-CoV-2.

The new immunoassay kit identifies IgG, IgM, and IgA, the complete immunoglobulin. This approach is considered to be more sensitive compared to assays against a single immunoglobulin.

Bio-Rad’s test is designed to be used manually or on an automated immunoassay platform, including its EVOLIS System. The system provides high-throughput processing and sample traceability.

The company plans to use the Food and Drug Administration’s (FDA) emergency use authorisation (EUA) process to expedite the availability of the assay in the US. It also intends to launch it globally.

In June 2017, Bio-Rad Laboratories received FDA clearance for its BioPlex 2200 Syphilis Total and RPR assay designed to diagnose syphilis infection.