College of American Pathologists
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  Immunoassay analyzers—what’s new and notable


CAP Today




June 2010
Feature Story

Brendan Dabkowski

Frequent air travelers might like at least one part of the Transportation Security Administration’s pre-boarding process. To reduce stress and wait times, TSA customizes its security lines—at many major airports—for three different types of travelers. A sign with a green circle indicates the line for beginner travelers, signs with blue squares mark the line for casual travelers, and signs with black diamonds designate the line for “expert” travelers. Giving passengers the option to be screened at their own pace usually results in fewer headaches and has boosted overall passenger throughput.

While TSA devises solutions to keep air travelers safe and happy, the companies that make immunoassay analyzers focus on solutions that help laboratories become more efficient and productive. These companies’ concerns lie not with the flow of passengers or wait times, but instead with laboratory workflow and test turnaround time—and a host of other variables. The systems profiled in CAP TODAY’s guide to automated immunoassay analyzers offer customers an assortment of options.

One way that Inverness Medical Professional Diagnostics is helping labs increase productivity, and responding to customer demand for complete automation in immunoassay testing, says marketing manager for AtheNA products Barbara Pasciak, is by adding a middleware software program to the company’s AIMS system. Set for release at next month’s American Association for Clinical Chemistry Annual Meeting and Clinical Lab Expo, the new program “will provide a streamlined interface with laboratory information systems, with bidirectional and host query capabilities,” she says. Also on tap at Inverness, pending FDA clearance (and not yet in the CAP TODAY lineup), are the AtheNA Multi-Lyte Torch IgG Plus test system, which is for the detection of IgG antibodies to Toxoplasma gondii, rubella, cytomegalovirus, and HSV-1/2; and the AtheNA Multi-Lyte Borellia VIsE-1 pepC10 Plus test system for the detection of IgG and IgM antibodies to VIsE-1 and pepC10, respectively. The company also introduced in the U.S. last year automatic enteric testing, and it is provided on the DS2 and DSX ELISA-based test platforms.

Appearing for the first time in the immunoassay analyzer product guide this year is Inova Diagnostics’ Quanta Lyser 2, a two-plate automated ELISA/immunofluorescence assay (IFA) system that holds up to 15 slides, says Ed Bass, instrumentation product manager. Introduced in 2008, the analyzer is for small labs and can be configured for ELISA or IFA test methods, or both. At the AACC meeting, Inova will introduce an automated IFA microscope that “will automate the reading of the IFA slides, capture a digital image, and store that image, all automatically.” Another product slated for release next month is the Quanta Lab data-management system, which Bass says is a middleware program specifically for the autoimmune laboratory.

Tosoh Bioscience launched last year in the U.S. its fully automated AIA-2000 immunoassay analyzer. The system has a throughput of 200 tests per hour and uses unit-dose test technology—meaning “the entire reaction takes place in this cup,” says Shanti Narayanan, senior product manager. The analyzer features automated record keeping and maintenance and a 17-inch touchscreen panel that provides easy access to most system controls. On the testing side, the company released last fall the AIA-Pack RBC folate assay, which is for measuring red blood cell folate in whole blood samples. And pending FDA clearance are the ST AIA-Pack cystatin C and HbA1c assays, which Narayanan says will be available in 10-minute incubation formats and can be used on all Tosoh AIA platforms.

The latest at Roche Diagnostics is a line of nine-minute stat cardiac biomarker immunoassays, which run on the company’s Cobas e 601 immunology analyzer. Released in April, the new assays include CK-MB, myeloid, and NT-proBNP. They enable hospital laboratories to obtain results in about “half the time required for standard Roche tests,” says Ed Gilligan, systems group marketing manager. Later this year, the company expects to file a submission with the FDA for the Cobas e 602 analyzer (not yet in the CAP TODAY lineup), which is the immunoassay module of the company’s Cobas 8000 modular analyzer series. The Cobas e 602 is designed to process 170 tests per hour and accommodates 25 onboard reagents, Gilligan says. The 8000, which is pending FDA clearance, includes two clinical chemistry modules along with the Cobas e 602 immunoassay module. Designed with the same operator interface as other Roche Modular platforms, the 8000 series will provide a peak throughput of 9,800 tests per hour and accommodate front-end automation.

An increasing demand for technology that enables automation, in general, is a driving force behind Roche’s approach to developing immuno­assay systems and other products, says Pete Van Overwalle, the company’s automation group marketing manager. While he concedes that automation technology will not necessarily make everything in the lab faster, Van Overwalle says what it does do is “help produce more consistent and predictable workflow. And that can have as big an impact on a lab’s overall efficiency and productivity as test turnaround time.” Roche released a few new products in April as part of its automation line: The Co­bas P 501/P 701 postanalytical units, which are storage and retrieval solutions that help labs streamline workflow and manage the lifecycle of sample tubes; and the Task Targeted Automation systems RSA Pro and RSD Pro, which enable high-volume labs to manage specimen processing during the pre- and postanalytical phases.

Another company responding to the demand for more automation technology is Siemens Healthcare Diagnostics, which targets for release in the U.S. later this year the Immulite 2000 XPi immunoassay system, says Mark Smith, senior global marketing manager, Immulite Systems. The analyzer provides automated sample rack loading and unloading and has a programmable auto-start feature and automated daily maintenance. Other changes at Siemens include planned menu and software enhancements for the Advia Centaur CP immunoassay system.

OrthoClinical Diagnostics’ Vitros 3600 immunodiagnostic system can now run assays for hepatitis C and HIV, says Bob Roda, vice president of clinical laboratory worldwide marketing. The Vitros 3600 system is a fully automated high-capacity analyzer that is easy to use, does not have any water or drainage requirements, and performs diagnostic checks throughout sample and assay processing, he says. The company expects to release an expanded test menu for the analyzer in July.

Finally, Phadia continues to expand its menu of EliA autoimmune assays on the Phadia 100 and 250 instruments and will soon offer a new set of EliA assays for the diagnosis of antiphospholipid syndrome and celiac disease. Fully automated tests for cardiolipin IgG, cardiolipin IgM, β2 glycoprotein I IgG, β2 glycoprotein I IgM, and gliadin DP are awaiting FDA clearance, says autoimmune franchise leader Gabi Gross. In addition, the company has two automated, high-throughput platforms in development to support the ImmunoCAP and EliA assays for allergy and autoimmune testing: the Phadia 2500 and 5000.

In CAP TODAY’s product guide are immunoassay analyzers from the aforementioned manufacturers and from Abbott Diagnostics, Awareness Technology, Beckman Coulter, The Binding Site, BioMérieux, Bio-Rad Laboratories, Diamedix, DiaSorin, Grifols USA, Hycor, Immunodiagnostic Systems, Radiometer Medical, Randox Laboratories, and Trinity Biotech. Companies supplied the information listed. Readers interested in a particular product should confirm it has the stated features and capabilities.


Brendan Dabkowski is CAP TODAY associate editor.

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