Bio-Rad Laboratories, a medical laboratory chain, has launched a blood-based immune assay kit for the detection of COVID-19 antibodies.
The serology kit has been developed to use manually or on an automated immunoassay platform like EVOLIS system of io-Rad Laboratories, which is claimed to provide high throughput processing and sample traceability. The kit has been designed to help to identify antibodies to the SARS CoV-2, the virus that causes COVID-19.
Clinical assessment of the serology assay kit is being conducted across various hospitals to further confirm its clinical performance. The preliminary performance of the assay was established by Bio-Rad Laboratories.
The medical laboratory chain said that initial data collected from more than 700 samples have shown more than 99% specificity.
According to Bio-Rad Laboratories, after a person contracts COVID-19, viral antigens in the body trigger the production of antibodies by the immune system to fight the virus.
The blood-based immunoassay kit helps to identify total immunoglobulin, including IgG, IgM, and IgA, an approach that looks to be more sensitive than assays against a single immunoglobulin, said Bio-Rad Laboratories.
The medical laboratory chain is planning to distribute the blood-based immunoassay kit all over the world and is intending to use the FDA’s emergency use authorization process to fast track the availability of the coronavirus detection test in the US.
Dara Wright – Bio-Rad clinical diagnostics group EVP and President 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.
“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.”