College of American Pathologists
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  Sensitivity, software, new tests for
  immunoassay needs


CAP Today




June 2008
Feature Story

Anne Ford

Even for the most dedicated technolo­gist or other laboratory professional, instrument-speak can get a little abstract, especially when it seems as if every other word ends in “osis,” “esence,” or “ism.” That’s where metaphors come in handy, especially in the form of images that appeal to the senses. And Dale Knight, Roche Diagnostics group marketing manager for immu­no­assay reagents, has a good one. “Imagine trying to find one blue M&M in an Olympic-sized pool of red M&Ms,” he says. “This is the level of sensitivity Roche’s proprietary electrochemiluminescence technology can provide.”

Now that we have your attention, chocolate lovers: This month’s instrumentation lineup focuses on immunoassay analyzers, some of which represent new or enhanced offerings. And with the American Association for Clinical Chemistry Annual Meeting and Clinical Lab Expo coming up in Washington, DC, July 27–31, now’s a good time to catch up on the latest and greatest products in the field.

That electrochemiluminescence technology Knight mentioned? It’s available on Roche’s Cobas e 411 system, a stand-alone instrument with nine-minute cardiac, pregnancy, and intraoperative parathyroid hormone testing, and the Cobas e 601 immunoassay system, which represents the full-menu immunoassay component of the company’s Cobas 6000 analyzer series. The ECL feature “allows faster turnaround times, while still maintaining sensitivity and broad measuring ranges,” Knight says. “As an assay example, the Roche human chorionic gonadotropin test provides sensitivity to 1 mIU/mL and a measuring range to 10,000 mIU/mL in a nine-minute test format.”

By early next year, he adds, Roche hopes to launch a new configuration of the Cobas 6000 series that “should allow twice as many distinct immunoassay tests or throughput up to 340 tests per hour to be performed on the integrated platform.” And the company is in the process of moving its cardiac stat, pregnancy, and IO PTH assay menu to the Cobas 6000, with the goal of reducing the 18-minute turnaround time by 50 percent.

Beckman Coulter is developing tests aimed at allowing laboratories to perform in-house what have traditionally been considered “specialty” assays. But as Richard Creager, corporate vice president of the company’s immunoassay business center, points out: “At the end of the day, a menu is only as good as the instrument it runs on.” That’s why, he adds, assay developers must have an in-depth understanding of the capabilities and limitations of the instruments that will run their tests.

To illustrate, Creager points to the recently released UniCel DxC 880i Synchron Access Clinical System, an instrument that combines chemistry and immunoassay functions on one integrated platform; it features the UniCel CTA, a closed-tube aliquoter that can perform up to 200 aliquots hourly. “The DxC 880i runs Access immunoassay reagent packs, which are identical across our complete family of immunoassay systems,” he says. “Identical reagent packs improve inventory management and use similar assay protocols, so that no matter what volume of testing is performed, patient results will be consistent. No other manufacturer offers this.”

The latest news at DiaSorin consists of new tests for its Liaison analyzer, a fully automated chemiluminescent benchtop instrument. Pending FDA clearance, the analyzer’s menu will include HSV-1 and HSV-2 type-specific immunoglobulin G assays. Total hepatitis A and hepatitis A IgM assays are in the works as well. The new tests will join the Liaison’s existing complement of assays, which includes tests for Treponema pallidum, Borrelia burgdorferi, Epstein-Barr virus, and varicella-zoster virus.

“Thanks to its high sensitivity and specificity, the Liaison Treponema assay can be used as a clinical laboratory screening test or as a confirmatory test,” says marketing manager Dawn M. Franzmeier. “And the Liaison Borrelia burgdorferi test can reduce the need for Western blot confirmation by up to 50 percent.” In addition, she says, “DiaSorin continues to provide the only fully automated, chemiluminescent, FDA-cleared, 25 OH vitamin D assay that detects both 25 OH vitamin D2 and 25 OH vitamin D3.”

New assays are also on tap at Olympus Life Sciences for its AU3000i immunoassay system. “Building on the steady stream of European-released AU3000i assays, this year Olympus will be releasing four tumor markers and more fertility assays for sale in the U.S. market,” says Lorraine Damico, director of immunoassay marketing. The AU3000i itself boasts a 300-sample onboard capacity, 4,800-test reagent capacity, and four-hour walkaway time. Later this year, Damico adds, the system will offer track connectivity as well, a feature that will allow labs “to configure chemistry, immunoassay, and other analyzers into a workcell with intelligent and lab-specific specimen routing.” The workcell will be on display for preview at the AACC meeting and is scheduled for release later this year.

This month the Binding Site expects to launch its ESP Connect interface software, a product that, says marketing manager Gary Tremain, “will make information exchange a much easier task than in the past.” He’s talking about the information exchange between a laboratory’s instruments and its information system. “Much of the custom software code required in the past can be replaced with an individual user configuration capability,” he adds. “A faster hookup means the focus can be on laboratory medicine and not information integration.” No argument there.

On the instrumentation side, last fall the Binding Site introduced its high-throughput ESP 600 ELISA system processor. “It’s being placed into major laboratories,” Tremain says. “This system is gaining a lot of interest for its ability to process high-volume runs faster than current four-plate systems, while also providing the laboratory significant reduction in operating costs through the elimination of costly consumables. Its patented micro pumping technology also eliminates high maintenance costs associated with syringe pump-based processors.”

Trinity Biotech continues to offer the automated TrinBlot system. Comprising a scanner, processor, and patented software, the TrinBlot can be purchased as a complete system or as individual components. The system “significantly speeds up the formerly tedious process of running and evaluating results of Western blots,” says marketing director Marlene Jinks. “It alleviates much of the cumbersome task of taping individual strips and reading and reporting results one by one.” While individual strips are still accessible, “TrinBlot affords multiple strip loading, processing, and reading in batches. Results are interpreted, stored, and reported electronically for final review and validation by laboratory personnel. The net result is significant time savings and related cost savings for the lab.”

Finally, last summer Phadia began offering the first of a new menu of EliA autoimmune assays, including those for cyclic citrullinated peptide, tissue transglutaminase, IgA/IgG, gliadin IgA/IgG, anti-extractable nuclear antigen screen, and double-stranded DNA. “EliA assays run on the proven, automated Immu­no­CAP instrument systems—ImmunoCAP 100ε 949 and ImmunoCAP 250. All EliA assays are CLIA-categorized moderate complexity,” says associate product manager Nicole Lampas.

CAP TODAY’s survey of immunoassay analyzers includes products from the manufacturers above and from Abbott, Awareness Technology, BioMérieux, Bio-Rad Laboratories, Diamedix, Grifols Quest, Inverness Medical Professional Diagnostics, Ortho-Clinical Diagnostics, Randox Laboratories, Siemens Healthcare Diagnostics, and Tosoh. Vendors supplied the information listed. Readers interested in a particular product should confirm that it has the stated features and capabilities.

Anne Ford is a writer in Chicago.

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