Instrumentation Development
The challenges of developing hematology instruments
Blood is the only fluid that flows throughout the entire human body. Blood analysis can detect a wide range of common physiological problems such as anemia, diabetes, autoimmune deficiencies, infections, and cancers. It can also expose genetic information, viruses, organ deficiencies, etc. Hematology is the study of blood cells. Hematology analyzer instruments can take the form of a relatively simple handheld unit, a more sophisticated point-of-care diagnostic instrument, or a highly complex...
Extending the lifespan of IVD kits
Thermo Scientific Nunc Immobilizer Streptavidin and Nunc Immobilizer Amino surfaces. The stability of all components in an IVD kit reflects its ability to maintain consistent, and therefore accurate, performance over time. Unlike commonly measured attributes, stability is problematic to assess prior to experimental use, and as such, there is a great onus on IVD manufacturers to ensure that any stability claims are substantiated. In today’s culture of mass manufacturing, extending...
Electronic and mechanical components and software
When designing an IVD or other medical instrument, most engineers look at the requirements as a group of mechanical, fluidic, electrical and software systems interacting to produce a desired result. Often, these engineers see only part of the picture. Quite a few factors come into play both during design and manufacturing and after the instrument is deployed. Following the design phase is integrating systems, performing validation, gaining approvals, manufacturing, and servicing in the field....
IT Innovations Raise the Bar for IVDs
Healthcare is being reshaped by IT. Some of the most influential solutions transforming the healthcare industry involve the flow of data, be it life-saving information transmitted to hard-to-reach locations following a natural disaster, or the aggregation of patient results on a single screen to accelerate actionable decision-making. The clinical laboratory environment is a relative newcomer to the widespread adoption of more sophisticated IT solutions compared to other segments of the...
Reading Alpha Assays
Further expanding the Synergy microplate reader family, the Synergy 2 Alpha microplate reader provides high-performance Alpha detection for low- to medium-throughput laboratories. Synergy 2 Alpha comes preconfigured with the Alpha filter set, mirrors, software, and optical modules to read all Alpha assays, and it is upgradable with additional detection modes as the laboratory’s needs change. Synergy 2 Alpha’s sensitivity is on par with that of laser-based systems, the manufacturer...
The State of Instrument Development
The most important consideration for the purchase of lab instruments is economics. Pressure to reduce operating costs has taken precedence over the previous decade’s focus on accuracy and convenience. While those two factors remain relevant, the drive to cut costs is key. Autocalibration and specimen ID are two additional considerations that carry weight in the lab today. To learn more about these and other trends in lab-instrument development, IVD Technology editor Richard Park spoke...
Pumps for IVD instruments: Controlling flow too small to see
IVD instruments encompass a broad range of analytical and performance functions, from separation and purification to detection and cell analysis. Many, if not most, of these instruments incorporate fluidic subsystems for sample handling and dilution, and reagent and buffer dispensing, or wash lines to prevent carryover and cross-contamination and eliminate waste fluids. Figure 1. Otto Folin in the chemistry laboratory at the McLean Hospital (Waverly, MA). As early as the 1930s,...
Introduction to Electronic and Mechanical Components and Software
Automated systems for the manufacture and quality control of IVDs consist of a combination of mechanical, electrical, and software components whose nature and mode of integration into a system must be specified in light of what the system will be expected to do. The manufacturer needs to thoroughly evaluate and define the tasks to be performed by the system and related process parameters. An automated microplate well coating system by Oyster Bay Pump Works (Hicksville, NY).  ...
Introduction to Filters, Membranes, and Bioseparation Equipment
IVDs based on traditional immunoassay procedures and immunochromatographic test strip materials have long been a hallmark of the biotechnology industry. Driven by technological progress as well as movement into new market niches, growth and development of IVDs remain strong. Recent scientific advances, the identification of novel biomarkers indicative of disease, and the movement of highly sensitive genomic and proteomic amplification technologies toward near-patient testing have spurred...
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...