Laboratory Automation
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...
Workflow analysis and performance evaluation of an automated blood testing system
Workflow, processing time, and staffing needs have emerged as key issues in the efficient testing and processing of donated blood. In addition to other testing technologies for infectious diseases, blood centers typically use nucleic acid amplification technology (NAT) to screen blood donations for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV). In some parts of the world, West Nile virus (WNV) has also become a significant public health concern in...
Sidebar: Active vs. Passive Debubbling
Because bubbles can be visualized, the hypothesis is that eliminating the bubbles eliminates the problem. Yet through experimental work aimed toward achieving very accurate dispense volumes, IDEX Health & Science has learned that while removing the bubbles upstream of the dispense pump helps a great deal, it does not totally eliminate the problem. To achieve completely accurate dispensing, active degassing or debubbling is necessary. Currently, many of the IVD instruments involve very rapid...
Improving dispense accuracy in IVD instruments
Although today’s typical IVD sample size of 100 µL of blood serum or reagent is not considered to be large by any measure, instrument design engineers widely recognize that this threshold is becoming an obsolete standard. At the same time, developing highly precise components, such as pumps that dispense volumes lower than 20 nL, creates new opportunities for system designers and method developers. For example, IDEX Health & Science LLC (Rohnert Park, CA) recently worked with a...
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...
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: Instrumentation and Automation
The IVD industry is infused with innovation, and the pace of discovery and development during the past 15 years has indeed been staggering. During this time period, genetic sequencing has been perfected and applied to the human genome, opening up numerous diagnostic and therapeutic opportunities. Significant advances in microfluidics and nanotechnology have enabled research lab discoveries to develop into clinical patient applications, both in the hospital and the physician’s office....
Achieving efficiency through lab automation
The following is an excerpt from a new report published by Kalorama Information (New York), “The Worldwide Market for Lab Automation”: “The overused and sometimes misused solution in the quest for efficiency in the clinical lab has been automation. Automation in the laboratory usually means optimizing workflow to increase output, shortening turnaround time in reporting test results, and utilizing less labor. Attempts to accomplish these objectives have focused on applying...
Improving lab automation by applying mechatronics
Mechatronics has contributed to progress in many industrial fields such as robotics, semiconductors, aerospace, automotive, consumer electronics, and medical. Well-known and well-established mechatronics systems include production systems, synergy drives, automated guided vehicles, automotive subsystems such as antilock braking systems, and commonly used spin-assist consumer products such as auto-focus cameras, hard disk drives, compact disc players, and washing machines. The main benefits that...
The Case for Regulating Laboratory-Developed Tests
Part one of this article, published in the November/December 2009 issue of IVD Technology, offered reasons why FDA should regulate laboratory-developed tests (LDT). Part two examines some reasons frequently given for not regulating LDTs and explains why each argument falls short of justifying FDA's inaction.   Imposing FDA regulation on LDTs would disrupt the use of important diagnostic tests   One rationale the agency has asserted is that, while it has the authority to regulate LDTs...