BD (Becton, Dickinson and Company), a global medtech, has received 510(k) clearance from the FDA for the BD Kiestra IdentifA system, designating it safe and effective. The system is designed to automate the preparation of microbiology bacterial identification testing.
Identifying the microorganism that is causing an infection is a labour-intensive process, BD says. With the company’s system, lab technicians can use informatics to select discrete bacterial colonies from a digital plate image. Robotics then physically pick those selected organisms and prepare the sample for specific identification testing. By automating what are typically manual steps, the system may reduce the potential for human error when preparing samples for bacterial identification.
"BD continues to invest in automation and innovation for the microbiology laboratory to enable smart, connected, end-to-end workflows designed to accelerate insights and efficiency," said Brooke Story, President of Integrated Diagnostic Solutions for BD. "Our 'discovery to diagnostics' strategy positions us to provide best-in-class solutions at every point along this continuum."
The integration of the company’s Synapsys informatics solution with the Kiestra IdentifA system, in combination with matrix-assisted laser desorption/ionisation-time of flight (MALDI-ToF) mass spectrometry, is hoped to yield more rapid and accurate identification of bacteria and yeasts to aid clinician treatment decisions.
"The BD Kiestra IdentifA system transforms the manual workflow into one that is standardised, automated and digitised," said Greg Miziolek, VP and General Manager of the US region for BD Integrated Diagnostic Solutions. "Mass spectrometry methods, including MALDI-ToF technology, have innovated and advanced microbial identification in clinical microbiology but often require a significant number of process steps and hands-on-time. The BD Kiestra IdentifA system uses automated colony picking and MALDI-ToF spotting to reduce time to pathogen identification, which in turn can help improve patient management."