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Bio-Rad accelerates production of antibody test

Bio-Rad Laboratories is accelerating production of its Platelia SARS-CoV-2 Total Ab test, a blood-based immunoassay kit to help determine if an individual has developed antibodies to SARS-CoV-2, the virus associated with COVID-19 disease.

Bio-Rad commercially launched the test in late April. Soon after, the test was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorisation (EUA), the first total antibody test to receive EUA from the FDA. Bio-Rad’s Platelia SARS-CoV-2 Total Ab test has also met the CE mark requirements for Europe, and it was validated by the Centre National de Référence, Paris, to be included in the official list of serological tests recommended by the French government for the detection of SARS-CoV-2.

The Platelia SARS-CoV-2 Total Ab test can help clinicians identify if an individual has been infected by SARS-CoV-2 and therefore has developed an immune response against the virus. The test detects three types of antibodies: IgG, IgM, and IgA, an approach that appears to be more sensitive than assays against a single immunoglobulin. Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 100 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.

Broad-based antibody testing can provide a more complete picture of infection rates and immunity to help public health officials in their efforts to reduce containment orders and better manage a potential second wave of COVID-19.

The Platelia SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad’s Evolis System, which offers high throughput processing and sample traceability.

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Upcoming Events

AfPP Annual Conference 2022

University of York
8-11 September 2022

Infection 360: What's trending in infection prevention & control

Edgbaston Stadium, Birmingham
27-28 September 2022

IP2022 IS COMING TO BOURNEMOUTH IN OCTOBER 2022

Bournemouth
17-19 October 2022

UKHCA Conference: Listen Up

Pendulum Hotel and Manchester Conference Centre, Manchester
3rd November 2022

MEDICA 2022

Dusseldorf Germany
14th November - 17th November

Future Surgery 2022

ExCel, London
15th - 16th November 2022

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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