The real-time polymerase chain reaction (PCR) test will detect DNA from MPXV in lesion swabs collected from individuals suspected of infection by their healthcare provider.
The tests will be conducted on Roche’s 6800/8800 cobas systems, which can also detect HIV, as well as hepatitis B and C viruses.
Testing will be limited to laboratories that meet the requirements to perform moderate or high complexity tests, the FDA outlined in a statement.
