The APAS Independence, an automated culture plate reader using AI and imaging analysis technology to screen out non-significant plates, has now completed CE Mark self-certification.

The CE Mark registration coincides with completion of the clinical study for the MRSA analysis module performed by key technology partner LBT Innovations. The APAS Independence with associated MRSA analysis module successfully met the target sensitivity and specificity requirements of the study. It will be made available for sale soon following finalisation of the documentation required to complete the Declaration of Conformity for CE Mark registration.

Testing for MRSA is much higher in the European Union than in other regions due to greater requirements for infection control screening. As such, MRSA testing, combined with urine, accounts for 50-70% of the specimens processed in the majority of laboratories. The high negativity rate of MRSA tests, which can be over 95%, makes it particularly well suited to the APAS® technology which automatically removes negative plates from the workflow, therefore providing greater value to customers.

Representing 35% of the global market, the EU is one of the largest microbiology markets. The Clever Culture Systems team will be showcasing the APAS Independence at the IBMS Congress 2019 in Birmingham this week as well as at ECCMID in Paris in early 2020. Outside of the EU, the MRSA analysis module will be available in Australia and in the United States after FDA clearance is obtained in early to mid 2020.