FDA Approves Mass Spectrometer System, VITEK MS That Can Identify 192 Different Tests at Once

This is pretty cool with the VITEK MS device, to have the ability to do a large number of tests at one time and there’s the remote connectivity so all don’t have to physically be in one place.  The videos below explain a bit more on how the system works and I would venture to say that the product stands to save some man hours with getting large numbers of results done at once.  4 target slides can be loaded at once with multi stations for collaboration for 4 technologists to work at the same time.  There’s middle ware software that does the connecting.

You can watch in the video that all samples are bar coded for accuracy and matching.    Below is a short description of all the working parts that go into using the testing system from the website.  BD

From the website:

VITEK^® MS
An automated mass spectrometry and software system designed for rapid microbial identification, using innovative matrix-assisted laser desorption ionization-time of flight technology (MALDI-TOF). This technology tests up to 192 isolates per run, delivers results in minutes, and requires no pretreatment of samples for even faster turnaround time. VITEK MS is easy-to-use, integrates seamlessly into your lab’s workflow, and enables more confident patient-care decisions with:

Etest^®
A predefined, stable gradient of 15 antibiotic concentrations on a plastic strip. Using innovative dry chemistry technology, Etest determines the onscale Minimum Inhibitory Concentration (MIC) of antibiotics, antifungal agents and anti-mycobacterial agents. More than 100 antimicrobials are available in the product range for testing of aerobic bacteria and fastidious organisms.

VITEK^® 2
Best-In-Class Technology Makes It More Than a Workhorse - With an expanded identification database and the most automated platform available, VITEK^® 2 is your lab’s powerhouse for rapid, complete, and accurate ID/AST:

• results in 4-8 hours enable targeted therapy sooner
• broadest range of GN AST cards includes the industry’s only FDA-approved three-drug yeast susceptibility card
• ergonomically sound automation that enhances workflow and minimizes waste
• immediate capability to integrate with your lab’s LIS and improve connectivity.

Myla™
An innovative software solution that simplifies lab operations by improving connectivity, workflow and information management.  The system offers an actionable picture of a lab’s workflow that rapidly impacts patient management with an intuitive dashboard and virtual workstations that enable lab personnel to recapture their time. Flexible, scalable, and versatile, Myla is designed to establish synergy with a facility’s existing Lab Information System (LIS) to improve broader access to patient data.

VILINK™
An on-line, highly secure connectivity environment that optimizes instrument ‘up time’ to improve laboratory productivity. It provides immediate access to the latest instrument application/analysis enhancements to further improve testing accuracy, and rapidly resolves platform issues to minimize the need for labor-intensive, off-line back-up testing procedures.

---

HealthDay News -- The FDA has approved a novel mass spectrometer system designed to identify 193 yeast and bacteria that are capable of causing pneumonia, meningitis and skin and bloodstream infections.

The automated system, VITEK MS (bioMerieux Inc.), can perform as many as 192 different tests in a single automated series, with each test taking about one minute, the agency said in a press release.

“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.

The FDA approved VITEK MS using its de novo classifcation process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

http://www.clinicaladvisor.com/fda-approves-novel-mass-spectrometer/article/308552/#