Roche announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for cobas MPXV for use on the cobas 6800/8800 Systems.
The test is a real-time PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection by their healthcare provider.
cobas MPXV targets two different regions of the MPXV genome, which are both less prone to mutations than other parts of the genome. This dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.
The high-throughput solution can help individuals get the right results quickly. This is important so that patients are not subjected to unnecessary additional testing or isolation, and will have access to appropriate treatment as soon as possible.
Like many viruses, monkeypox cannot be conclusively diagnosed by symptoms alone. This is because many monkeypox symptoms closely resemble those of other rash-producing illnesses such as chickenpox, measles, bacterial skin infections, and even hives or allergies.
About the test
cobas MPXV is intended for use for the qualitative detection of DNA from monkeypox virus in individuals suspected of monkeypox infection by their healthcare provider.
cobas MPXV for use on cobas 6800/8800 Systems is the first monkeypox virus test granted EUA following evaluation in actual patient samples rather than just samples formulated in the laboratory.
The assay uses β-globin, a target present in human DNA, as an endogenous control to ensure specimen adequacy.
Unlike the previously cleared assay, cobas MPXV detects monkeypox nucleic acids and the endogenous control in the same well, improving laboratory efficiency by effectively doubling the number of clinical samples a laboratory can assess on each plate and halving reagent needs per sample.
cobas MPXV is only for use under the FDA’s EUA in laboratories certified under Clinical Laboratory Improvement Amendments that meet requirements to perform high or moderate complexity tests.
Laboratories within the U.S. and its territories are required to report all results to the appropriate public health authorities.
cobas MPXV is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas 6800/8800 Systems.
About the cobas 6800/8800 Systems
The Roche cobas 6800/8800 Systems provide results in three and half hours and offer improved operating efficiency, flexibility and fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System in 24 hours.