Automated Blood Culture System Receives FDA Clearance
By Labmedica International staff writersAn innovative blood culture microbial detection system is now commercially available in countries that recognize CE marking and in the USA and is the first continuously monitoring blood culture microbial detection system to offer “Load & Go” technology.
Posted on 19 Apr 2017
Posted on 19 Apr 2017
Personnel of all skill levels can easily load bottles on the instrument at any time throughout the day or night, enabling prompt incubation and reducing hands-on time. Bottle unloading is fully automated with visual and audible alarms and alerts, helping laboratories to streamline their workflow.
The US Food and Drug Administration has given 510(k) clearance to the blood culture microbial system. The BacT/ALERT VIRTUO system that received FDA approval, offers powerful proprietary algorithms, high thermal stability and superior optics, which enhance blood culture performance for more rapid time to detection. This translates into faster identification of bloodstream infections. This unrivalled blood culture system further enriches the BacT/ALERT product line for blood culture. It offers an integrated configuration with scalable incubation capacity from 428 to 1,712 cells and facilitates the management of high volumes of blood cultures.
A unique blood level detection technology measures the blood volume in each blood culture bottle at the time of loading. This feature helps laboratories track and ensure collection of the recommended blood volume in order to be compliant with accreditation and quality guidelines. This is a significant benefit to patient care, since the blood volume collected is a critical factor in detecting bloodstream infections. BacT/ALERT VIRTUO utilizes the FANPlus media, which are formulated to optimize antibiotic neutralization with optimal growth performance of microorganisms.
François Lacoste, Vice President-Clinical Unit at bioMérieux, said, “We are proud to receive this FDA clearance for BacT/ALERT VIRTUO, which allows us to enhance our blood culture offer to our customers in the USA. This highly automated blood culture solution enables faster detection of pathogens by clinical microbiology laboratories, which is of crucial importance for optimal patient treatment, especially in life-threatening conditions such as bloodstream infections which may progress to severe sepsis.”