Immunoassays comprise one of the largest segments in the IVD industry, and their role will increase and evolve in the postgenomic era.
Since the 1960s immunoassays have contributed enormously to clinical lab medicine. During the past few years, immunoassays of all kinds (e.g., automated, manual, ELISAs, enzyme immunoassays, bead arrays, microarrays) have dominated the IVD market, and have become one of the primary and indispensable tools in diagnosing and monitoring in all areas of medicine.
The market potential of immunoassays is now even greater than before. The publication of the human genome in February 2001 catapulted immunoassays into a new and revitalized area known as postgenomic medicine. Lab medicine in this postgenomic era involves tests based on protein and nucleic acid targets derived from human genome research. Gene identification is the first step, with the next step involving the detection of physiological elements (e.g., proteins, hormones, enzymes) expressed by genes. Immunoassays are used to test for all of these entities.
IVD manufacturers are continually looking for immunoassay technologies that can detect nano-, pico-, and even femtomolar concentrations of proteins in clinical samples. The reason is that the key to diagnosis is measuring the differences between normal and abnormal concentrations of potential disease markers in blood, urine, saliva, and other fluids. However, most immunoassay technologies in routine use today do not have the sensitivity needed to detect many of the new markers. New ultrasensitive test methodologies are needed to allow researchers to detect highly specific markers for diseases such as diabetes, cancer, osteoporosis, arthritis, and cardiac disease.
Taking into account such trends, this issue discusses some of the latest technology developments in assay development.
Author Ranjit Malik of Adhesives Research Inc. (Glen Rock, PA) discusses how porous adhesive technologies offer a stable porous format to enable new diagnostic capabilities and simplify IVD device designs while increasing functionality. His article, “Porous Adhesive Technology for Diagnostic Applications” (page 27), examines a porous adhesive format that has been developed in a number of adhesive chemistries to address varying environmental conditions and chemical requirements.
Authors Tobias Polifke and Peter Rauch of Candor Bioscience GmbH (Weissensberg, Germany) discuss how human antimouse antibodies (HAMA) effects can be overcome by a HAMA blocker. Their article, “Using Affinity Discrimination to Avoid Interference Effects in Assays” (page 33), looks at a new technological approach that minimizes not only HAMA problems but also any other kind of interference, in which only a new assay diluent has to be used.
For the In Person interview, IVD Technology spoke with Marsha Oenick, group director for assay development at Ortho-Clinical Diagnostics (Rochester, NY). In this interview (page 22), Oenick talks about integrating new detection technologies into multifunctional instruments, working with scientific and clinical researchers outside the IVD company, and finding satisfaction in bettering the health prognosis of future generations.