IVD Technology

March/April 1999
Selected Contents

Editor's Page

What's in a name?

COVER STORY:

Stability Issues for Protein-Based In Vitro Diagnostic Products
by Patrick E. Guire

Maintaining the stability of dry and liquid protein reagents can require significant experimentation during the product development phase of a new immunoassay.

Europe's IVD Directive: More work ahead for diagnostic manufacturers
by John F. Place

Even with the directive's waiting period, manufacturers may find themselves hard pressed to achieve conformity by the final implementation date of December 7, 2003.

Regulations and standards:
Regulatory options for IVDs: Selecting the best path to market
by Jeffrey N. Gibbs

For most medical devices, the regulatory pathways to market are, if not always easy to navigate, at least easy to discern. Yet the variety and complexity of these few regulatory options pale by comparison with the choices available to IVD companies.

Troubleshooting protein binding in nitrocellulose membranes—Part I: Principles
By Kevin Jones

Developers of membrane-based assays should have a firm grasp on the various factors that can influence protein binding—including those inherent in the materials and processing used for their tests.

Markers

Soluble Markers of Immune System Activation (Part II)—AIDS prognosis and the clinical utility of ß2-microglobulin
David George

Studies suggest that serial measurements of immune system activation markers could have value for monitoring the progress of HIV disease.

News Update:

FDA approves first home-use tumor marker
The BTA stat test for recurrent bladder cancer has achieved a unique position as the first tumor marker test to receive FDA approval for home use.

Painless technologies make headway in glucose market
When it comes to blood glucose monitoring devices, manufacturers know that noninvasive sampling is the ultimate goal.

Noninvasive diagnostic technologies emerging
Progress in the development of noninvasive diagnostic technologies is being made along several fronts, and for a variety of conditions.

Detection of gene mutation may improve cancer treatment
If future research proves out, the status of a gene implicated in a variety of familial cancers could prove to be a key factor in designing patient treatments.