Detection Technologies
HIV seroconversion panels
A company offers six new highly characterized seroconversion panels for current assay qualification. The HIV seroconversion panels feature enhanced product information, including Fiebig stage and fourth-generation screening-test results. Each panel consists of a set of undiluted plasma samples from a single plasma donor during a period of HIV seroconversion, and is ready to use in vials of 1.0 ml per patient sample. Data sheets for each panel list results from twenty U.S. and international test...
Detection Technology: Where It Stands and Where It’s Headed
In the field of detection technology, advances in multiplexing and the increasing emphasis on point of care are of primary importance. Trends include nonenzymatic and isothermal approaches for nucleic-acid testing, which reduce the complexity of very complicated molecular assays. The primary challenge right now is the front-end automation: sample acquisition and preparation. To learn more about what’s new in detection technology, IVD Technology editor Richard Park spoke with John C....
15th Anniversary Essay: Detection Technologies
An article on detection technologies that was previously published in IVD Technology’s 10th anniversary issue covered the more traditional means of developing assays that had already been commercialized and used for some time.1 That article also covered matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) technology in order to show some of the newer techniques for protein detection in human plasma and its use in tissue imaging (e.g., detection of cancerous tissues...
Enhancing assay performance using nanoscale detection
Most immunodiagnostic and nucleic acid detection methods have in common the use of a solid surface onto which a bioactive reagent is coated, such as an antibody, antigen, or oligomeric probe. Such biomolecules are complex long-chain structures possessing optimal three-dimensional conformation with specific loci for binding sites or epitopes. However, the conventional deposition of bioactive molecules onto solid surfaces is an inefficient and random process. For example, while antibodies can...
Automated image analysis for developing IVDs
With the promise of personalized medicine and effective targeted molecular therapeutics on the horizon, developing translational IVDs that can accurately select patients for specific therapies or treatment regimens has become more critical. Two of the best known examples in oncology are the examination of estrogen receptors and HER2 expression using immunohistochemistry (IHC) to predict the response to tamoxifen and Herceptin, respectively (see Figure 1). As a measurement of expression in fixed...
Rapid detection of non-radioactive GFR markers
Chronic kidney disease (CKD) is a major medical problem in the United States and the rest of the world. In 2008, a 30% increase in CKD cases during the past decade prompted the U.S. Renal Data System (USRDS) to issue for the first time a separate report documenting the magnitude of the disease, which affects an estimated 27 million (or one in ten) Americans and accounts for more than 24% of Medicare costs.1 An earlier report also estimated that at least 20 million more people are at risk for...
Promises and challenges of companion IVDs for oncology
Several conferences held last summer provided a basis for the notion that a relative gold rush of companion diagnostics in oncology is nearing reality. However, cancer biomarkers also present unique complexities for the lab industry, regulators, and physicians. The American Society for Clinical Oncology (ASCO) focused its 2009 meeting on the idea that a personalized medicine approach must become the standard for effective clinical oncology. Three years ago, Her-2/neu stood...
Lateral-flow assays using time-resolved luminescence
  While the consumer IVD market has undergone tremendous growth in recent years, it has been primarily dominated by glucose monitoring tests. A limited number of other types of IVD products are available on the over-the-counter (OTC) consumer market, and many of them can generate only qualitative test results for a small number of conditions. In order to expand the OTC market, the desired IVD products in this market need to be inexpensive but yet should deliver quantitative results...
Advances and challenges in detection technology
              Christopher Cooney, PhD, is director of engineering at Akonni Biosystems (Frederick, MD). He oversees the development of an on-chip PCR microarray flow cell, a microarray imager, a thermal cycler, an automated sample-prep device, and a point-of-care sample-to-answer microarray instrument. He has worked in microfluidics and biosensors for 10 years. Cooney can be reached at cooney@akonni.com. New developments in detection...
Electrochemical detection-based DNA microarrays
Figure 1. The eSensor XT-8 system by Osmetech Molecular Diagnostics (Pasadena, CA). Until recently, multiplex technology, such as real-time polymerase chain reaction (PCR), could analyze only a small number of polymorphisms in a single test. The multiplexing capabilities of DNA microarrays have improved, thereby increasing the number of independent genotypes that can be determined simultaneously. Early microarrays focused on high-density applications that...