BD GeneOhm™ MRSA ACP Assay Gets FDA Clearance
BD Diagnostics has received clearance from the FDA to market the BD GeneOhm™ MRSA ACP assay, a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization.
The BD GeneOhm™ MRSA ACP assay incorporates achromopeptidase (ACP) lysis, which results in fewer assay steps and less hands-on time. Improvements delivered by this assay include:
- 15% reduction in workflow steps
Assay concentration and centrifugation steps have been eliminated.
- 50% reduction in hands on time.
Assay concentration steps have been eliminated AND a new septum cap has been incorporated, which allows for direct sampling.
- Initial sample re-test rate of 1%.
The combination of ACP and reformulated master mix reagent reduces the number of initial sample repeats that need to be performed.
- Ability to perform follow-up testing without additional sample collection.
Sample buffer allows for follow-up testing (culture and/or PCR) without requiring a dual headed swab.
- Enhanced control features to monitor assay steps.
Control DNA are now processed through the lysis, amplification and detection steps.
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