The US Food and Drug Administration (FDA) has given emergency approval for use of the serological test developed by Swiss pharmaceutical giant Roche, the company announced on Sunday.
The test is designed to determine whether a person has been exposed to the new coronavirus and developed antibodies against the disease.
The Basel-based firm says that its Elecsys Anti-SARS-CoV-2 test has a specificity rate of 99.8% – which lowers the chance of false positives – and detects antibodies with 100% sensitivity.
Roche has started shipping the new test to laboratories around the world and says it plans to increase production to "high dougle-digit millions per month" to supply countries that accept the CE mark as well as the US.
Scientists worldwide are in a race to develop serological tests, as results can help policy-makers better understand the disease, determine who may have had the virus and who may have immunity, and what measures may still be needed to fight the pandemic.