For the qualitative detection of MPXV DNA on cobas® 6800/8800 Systems
Monkeypox virus (MPXV) have been declared a Public Health Emergency of International Concern (PHEIC) by WHO (23Jul2022) and Biden administration (04Aug2022). Combine the high quality, dual target, moderately complex cobas® MPXV test with the transformative automation that the cobas® 6800/8800 Systems provide to respond with confidence to this public health emergency.
Detection of MPXV nucleic acids
MPXV-specific nucleic acid sequences from the double stranded RNA-binding protein and the membrane-associated glycoprotein genes in the FAM channel for MPXV detection.
Detection of the human b-globin gene
Endogenous control HBB Hemoglbin subunit b. Conserved sequences of the human b-globin gene in the HEX channel to provide a sample adequacy control.
Internal control to monitor the entire sample preparation and PCR amplification process. Detection in the CY5.5 channel.
A positive and a negative control is included for each batch to guarantee validity of each run/ batch.
* A dead volume of 0.2 mL was identified for cobas omni Secondary tubes when performing the workflow according to the IFU. Other tubes compatible with cobas® 6800/8800 Systems (consult the User Assistance Guide) may have different dead volume and require more or less minimum volume.
Emergency Use Authorization
cobas® MPXV for use on the cobas® 6800/8800 Systems is approved for use under the Emergency Use Authorization (EUA) by FDA.