From the July/August Issue
Laboratory Automation
Middleware: Providing value beyond autoverification
Clinical labs are exploiting middleware to differentiate their services while eliminating mundane tasks.
Latest Industry News
In Person
Jack Levine
Chair of the American Association for Clinical Chemistry industry division
Expanding the role of industry
The AACC industry division helps members manage market shifts, adapt to global guidelines, and build positive relationships with laboratorians.
Six years since its inception, the American Association for Clinical Chemistry (AACC; Washington, DC) industry division continues to find common ground between industry manufacturers and clinical chemists and address the interests and concerns shared by both. Gathering feedback and encouraging laboratorians to take advantage of the industry division’s role in facilitating change has spurred the collaboration of clinical chemists from every industry setting. In an attempt to expand the division’s role and influence on the national stage, the IVD industry hopes to tackle the shared concerns of all division members regarding efficiency, productivity, and compliance.
Click here to read the interview.
Current Editorial Focus
Point-of-Care Technologies
Magnetic immunoassays: A new paradigm in POCT
Magnetic-bead detection technologies exploit the nonlinear features of superparamagnetic materials embedded in magnetic beads.
Developing point-of-care A1c tests for diabetes monitoring
With the availability of POC A1c tests, physicians can get results and adjust treatment regimens during patient visits.
Final Thoughts
Reducing FDA clinical utility determination
by
Glen Paul Freiberg
IVD tests are medical devices defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Although clinicians ultimately determine whether to use a medical device, the use of IVDs allows clinicians to determine how to use the test results as well. Unfortunately, rather than choosing and evaluating risk related to the IVD device itself, clinicians often focus only on test results and ranges.
