Assay Development
Introduction to Biochemicals and Chemical Reagents
All IVD assays require chemicals and biochemicals. Choosing and sourcing these components are very important steps in the development and manufacture of any IVD product. The wrong choice of assay buffer, for example, can make all the difference between an assay that performs very well and one that exhibits poor precision or poor sensitivity. Excellent product performance combined with appropriate marketing approaches results in better sales, of course, which is a major objective of most...
Introduction to Assay System Components
In vitro diagnostic assays play an important role in diagnosing disease, as well as monitoring and managing treatment. They touch nearly every area of patient care, from chemistry and toxicology assays used to monitor the effects of therapeutic drugs or detect drugs of abuse, to immunological tests that detect tumor markers as part of cancer screening diagnosis, to microbiological tests that can detect infectious disease. Nearly every patient will undergo some type of in vitro diagnostic...
15th Anniversary Roundtable: IVD Past, Present, and Future: Three Experts Weigh In
In vitro diagnostics is, by many accounts, an underrated, undervalued industry. While pharmaceutical and therapeutic medical-device innovations tend to garner most of the mainstream media’s attention, the fact remains that 60 to 70% of medical decisions are influenced by some type of diagnostic testing, yet diagnostics accounts for only a tiny fraction of overall healthcare spending.  Some of the major developments within this very important industry during the past 15 years include...
15th Anniversary Essay: Assay Development
During the past five years, the pace of changes in IVD assay developers’ working practices has accelerated significantly. Three of the trends that were discussed in an article published five years ago in IVD Technology’s 10th anniversary issue have continued to have a direct positive impact on the development of IVD assays, which are the following: the improvement of communication among researchers; the improvement in and development of detection technologies; and the continued...
Using recombinant monoclonal antibodies to develop IVDs
The use of monoclonal antibodies in IVD kits and assays has already been well established. However, the development of highly sensitive and specific monoclonal antibody-based detection systems can be hampered by the unpredictability and inflexibility of traditional hybridoma technology. Through significant advances in genetic engineering, creating recombinant monoclonal antibodies is now possible by using well-tested phage display technology. Such antibodies match the strengths of traditionally...
Assessing the future of immunoassays
A report by Kalorama Information (New York), “The Worldwide Market for In Vitro Diagnostic Tests,” concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment. However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease...
Automated quantitative microarray assay platforms
            Figure 1. SQiDworks diagnostics platform. Protein microarrays have become powerful tools for examining various aspects of the immune system. Investigators can now test for the presence of multiple specific (multiplexed) antibody reactivity in patient samples with one reaction by using antigen microarrays spotted on planar substrates.1 For example, such microarrays can identify clinical subtypes of rheumatoid arthritis.2 However, unique...
Introduction to assay system components
      The Exact Volume Pipets by Poly-Pipets Inc. (Englewood Cliffs, NJ) can deliver specific dispensing requirements and are available in drop sizes from 20 ul to 400 ul. While the 1990s may have been the true brink of the point-of-care (POC) era, the new millennium may be the era of mergers and acquisitions. Regardless, modern IVD technologies have changed over the last two decades at a rapid pace akin to the other technology sectors and the pharmaceutical...
Introduction to filters, membranes, and bioseparation equipment
      Membranes and filters are available in a variety of formats and can be customized for diagnostic sample preparation and detection. IVDs based on traditional immunoassay procedures and immunochromatographic test strip materials have long been a hallmark of the biotechnology industry. But recent scientific discoveries, the identification of novel biomarkers indicative of disease, and the increased sensitivity of new detection systems have spurred expansion of...
Introduction to Biochemicals and Chemical Reagents
      Different kinds of chemical and biochemical solutions are used in enzyme-linked immunosorbent assays (ELISA). All IVD assays require chemicals and biochemicals. Choosing and sourcing these components are very important steps in the development and manufacture of any IVD product. The wrong choice of assay buffer, for example, can make all the difference between an assay that performs very well and one that exhibits poor precision or poor sensitivity. Excellent...