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17th April 2020  Editorial by: Paul Carton

Roche High-Throughput COVID-19 Serology Test for cobas e Analyzers Ready for Early May

Roche has developed a serology test to run on its cobas e Analyzer, which depending on the model, has a throughput of up to 300 tests p/h. Roche has stated in a recent press release that the test will be ready in early May for countries accepting the CE-mark, and an FDA-EUA  application is in process. 

Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in vitro detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus.

Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes.

As countries around the world begin a gradual return back to work, as signs of transmission rates in the community are dropping, there will need to be testing regimes in place to ensure the patient is getting the right treatment and risk is minimal in discharged ones. 

Testing regimes for discharging patients, currently rely on PCR tests to check for viral clearance, with Italy being the exception, requiring a serology test to be done in tandem.

However, the European Centre for Disease Prevention and Control (ECDC) is recommending the use of serology tests along with PCR tests, to check for specific IgGs for the virus, before a patient is discharged.  

Living alongside the virus, is something countries are having to accept for the foreseeable future. And if this is to happen, the virus and our immunity to it needs to be better understood. Scientific gaps still remain on the viability of the virus in patients who are post-symptomatic, and whether this person is immune can no longer infect others.  

With many healthcare workers being deployed to nursing homes, where clusters have resulted in tragic losses in the community, serology information might be what is needed before economies collapse. This immunity awareness will better inform health departments on lifting restrictions on the public and also in deciding what treatment is needed for the patient. 

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Date Published: 17th April 2020

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