This is especially true of immunoassay systems, which are among the most mechanically advanced of all medical devices. In general, these remarkable machines are able to perform high volumes of dozens of assays related to abused drugs, toxicology and therapeutic drug monitoring, anemia assessment, oncology, cardiac status, endocrine functions, fertility and pregnancy, hepatic and renal function, oncology, infectious disease, and many others.
More than a dozen manufacturers produce these systems worldwide and their features vary widely, but all offer reliable, workhorse devices that form a backbone for clinical lab productivity and that have evolved to require minimal maintenance or technician interaction. Here is a brief overview of two prominent products in this highly competitive category. Note that each of the companies mentioned manufactures a range of devices to accommodate the size and production levels of both large and small laboratories.
Abbott Diagnostics, a division of Abbott Laboratories, Abbott Park, Ill., describes its AxSYM as the leading immunoassay system in the world. It is used in more than 10,000 laboratories across the globe. This system combines continuous access, random access and STAT processing with a broad testing menu. AxSYM allows medium- and higher-volume clinical laboratories to process a variety of immunodiagnostic tests simultan eously, while also adding tests while the instrument is running.
In 2004, Abbott introduced the systems third generation, AxSYM Plus 5.0, which includes improved ergonomics, increased ease-of-use and hardware and software upgrades that provide high-integrity results with less operator intervention. The system is designed to handle 80 to 120 tests per hour, making it suitable for all but the highest-volume environments. In December 2005, Abbott announced their submission to the FDA seeking pre-market approval (PMA) for a hepatitis HBsAg/Confirmatory test for use on its AxSYM instrument. In the second half of 2006, Abbott plans to introduce the ARCHITECT ci16200, a high-volume integrated system.
In 2004, Tosoh Bioscience, Inc., headquartered in Tokyo, Japan, introduced their fully integrated floor standing immunoassay analyzer, the AIA-1800. With this product, Tosoh combines an appreciable throughput (180 tests per hour) with a thorough test menu, automated functions and ease-of-use in a mid-sized format. The test menu reagents for the AIA-1800 are made in the AIA-PACK test cup format, described as pre-measured units of dried reagent that require no preparation or on-board refrigeration. The test menu for the AIA-1800 includes tumor markers, thyroid, reproductive, cardiac, and anemia, and metabolic assays.
Automated features of the AIA-1800 include bar-coded primary tube sampling, auto dilution, auto pretreatment, dual clot detection and automatic inventory management of reagents and supplies. To make operation user friendly, Tosoh uses a Windows-based interface to drive the continuous workflow features. The thorough UK Medicines and Healthcare products Regulatory Agency (MHRA) report notes good reliability and customer support of the AIA-1800.
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