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When Volume Matters, Immunoassay Systems Deliver


Although new and innovative technology has enabled more and more laboratory testing to occur at the bedside or physicians office, the central laboratory is hardly threatened with extinction. National volume data suggest that medium and large labs are busier than ever before, and the huge range of their capabilities, gold standard reliability and ability to handle very large volumes of tests assures them an abiding and pivotal position in the clinical landscape.

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 some of the leading products in this 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 simultaneously, while also adding tests while the instrument is running.

The company has recently introduced the systems thir d 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.

Among special features, the system offers in-line pressure monitoring, foam avoidance, enhanced exception management features, ratio calculation and STAT rerun capabilities

The Access Immunoassay System from Beckman Coulter, Inc. Fullerton, Calif., is a random access bench-top analyzer that performs a variety of assays, with standard panels and specialty applications. Combining chemiluminescent technology with a broad menu, the company says the Access system is designed for profile testing in the core lab or STAT and emergency testing in the rapid response/STAT lab. The device handles up to 100 tests per hour. Its carousel design allows easy placement of both samples and reagents.

This device features a test menu of 24 resident assays and allows any test to be run at any time. On-board refrigeration promotes reagent stability. The devices reaction vessel loader provides capacity for up to three hours of continuous sample processing

Integrated reagent packs contain all necessary assay-specific reagents in self-resealing bar-coded packs requiring no reagent preparation. Automatic onboard waste disposal is self-sealing and is easily replaced, reducing exposure to biohazards.

PerkinElmer Life and Analytical Sciences, Inc. Boston, Mass., manufactures the AutoDELFIA automatic immunoassay system, which is aimed at larger and medium-sized routine diagnostics or population screening laboratories. It automates all sample and reagent handling as well as all assay stages, including measurement.

Loading capacity is 432 primary sampling tubes and results for up to eight different tests can be derived from one sample. The system runs from an external PC with a Windows-based program and mouse control. MultiCalc software allows direct linkages to a mainframe or LAN.

Bayer HealthCare Diagnostic Division, Tarrytown, N.Y., a unit of the German firm Bayer AG, produces the ADVIA Centaur system, designed for flexible operation and integration with diverse laboratory automation systems. This high-volume product offers a walk-away capacity of up to 840 tests and is able to process 240 tests per hour. It holds 180 samples when fully loaded and offers unattended automatic repeat, dilution and reflex testing.

The system features no-pause loading of all reagents, samples and suppliesthe only immunoassay system with this capabilityand requires no daily start-up routine. Its continuous sample loading design allows samples to be run as received for faster turnaround time. A dedicated STAT port prioritizes STATs automatically, without further operator intervention or disrupting work in progress. STAT results are available in 18 minutes.

This large system is highly versatile; core immunoassays include: fertility, therapeutic drug monitoring, infectious disease, allergy, cardiovascular, anemia, oncology and thyroid. Over 300 specific IgEs, mixes and an allergy screen are also available and the company says that it is aggressively expanding the systems menu and developing novel assays for cardiovascular, oncology, allergy, HIV and complete hepatitis panels.

While bedside and clinic testing offer the advantages of immediate results and caregiver-patient interaction, the day-in, day-out demand for high volume test production in the hospital or large clinic assure that multiple-application devices like those highlighted here will remain a necessity of modern care. As manufacturers continue to refine and improve these systems in response to fierce competition, laboratories and patients can only benefit.
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