IVD Technology

March/April 1998
Selected Contents

Cover Story: Cardiac markers: Developers enter a new era of progress
by Greg Freiherr

Use of cardiac troponin markers has vastly improved the care that physicians are able to provide to patients that have suffered acute myocardial infarction. But now, IVD manufacturers are eyeing biochemical markers that may provide warning signs of an impending heart attack—before it occurs.

Development of monoclonal antibodies and a rapid assay for tuberculosis
by Richard T. Root, Abu F. Raisur Rahman, Minal Ashtekar, and Salman H. Siddiqi

Distinguishing tuberculosis from other respiratory complaints is a major challenge for physicians throughout the world. A culture confirmation test that is inexpensive, easy to use, and easy to interpret, would find a ready market.

Molecular tools for building nucleic acid IVDs
by Norman C. Nelson

In the past decade, the technology for molecular diagnostics has made rapid progress toward greater sensitivity, improved specificity, and a wider selection of commercially available test kits. But the industry is still young, and much remains to be accomplished.

Regulations and Standards:
by Jeffrey N. Gibbs

FDA's RUO/IUO Policy: A Small Step Forward