College of American Pathologists

  Immunoassay analyzer market: more tests, tools, systems


CAP Today




June 2013
Feature Story

Brendan Dabkowski

They’ve added tests to their menus, tools to their instruments, functionality to their software. Two companies—Alere and Corgenix—introduced new systems.

In short, the companies whose immunoassay analyzers are profiled in CAP TODAY’s product guide are doing what they can to help labs do what they must.

“Customers will continue to partner with their providers to receive more-simplified tests and instruments, that are even more intuitive and reduce non-value-added tasks, and outside-of-the-box solutions to help with overall lab management,” says Colin Hill, Ortho Clinical Diagnostics’ director of worldwide marketing for clinical laboratories.

Alere’s Karen Davis-Fleischer says labs are looking for platforms that provide the ability to test higher volumes of samples more efficiently and economically than ever before.

One such high-throughput solution is Alere’s Agility ELISA processing system, set for release July 15. The fully automated instrument features walkaway processing, with flexible throughput that allows up to 12 plates onboard simultaneously, says Davis-Fleischer, the company’s senior director of clinical marketing. Agility uses three “precision” robotic arms—one to pipette samples, another to pipette reagents, and a third to transport plates and consumables—and has an intuitive interface. The platform requires little hands-on time, owing in part to the company’s SmartKit packaging, which is a “direct-load solution to front-end ELISA kit preparation,” Davis-Fleischer says. Also in the product guide are Alere’s DSX (four-plate) and DS2 (two-plate) EIA platforms.

New to the product guide this year is Corgenix, which markets its SkyLab 752 dual-pipette automated ELISA analyzer, released in September 2012. Similar to Agility, the SkyLab 752 platform uses three robotic arms to speed the processing of a seven-plate run, says Christopher Lynn, national sales and service manager. One arm houses the dual pipettes, a second houses the wash head, and a third arm transports plates to an incubator/shaker if required by the assay. “A true seven-plate run can be initiated with simultaneous processing,” Lynn says, “as opposed to previous generations that analyzed plates in a staggered pattern.” SkyLab 752 is an open system and registered with the FDA as a class I device. System malfunctions can be diagnosed remotely, and troubleshooting and software upgrades can be sent via an Internet connection. Next year, Lynn says, the company will add functionality to the system that will allow it to process up to 28 immunofluorescence assay slides in one run.

Ortho Clinical Diagnostics recently implemented the QC Optimizer tool and Rule tool for its Vitros systems. With QC Optimizer, operators can “more efficiently run the fluids, allowing patient results to be reported sooner,” Hill says, while the Rule tool provides a printed list of reagent packs and cartridges to help operators manage daily supplies. Ortho added to the test menus of its Vitros systems an automated total vitamin D assay, which, Hill notes, enables low- to mid-volume labs to perform vitamin D testing in-house rather than send it out.

Inova Diagnostics has added FDA-cleared ENA 7 Screen, Sm, and RNP connective tissue disease tests to the menu of its Bio-Flash rapid-response chemiluminescent platform, says instrumentation product manager David Moore. The system was fully launched in the U.S. in January and has 17 FDA-cleared tests for diseases such as antiphospholipid syndrome, celiac disease, and vasculitis. The platform improves workflow and reduces hands-on time compared with other enzyme-based test systems, Moore says. Bio-Flash stores the company’s self-contained Quanta Flash reagent cartridges, and assays need to be calibrated only once per lot of reagents. The platform provides the first test result in 30 minutes and additional results each minute thereafter, and it can begin testing instantly when operators arrive in the morning. “Bio-Flash provides true random access for autoimmunity testing, allowing you to test any patient sample on any assay at any time,” Moore says.

Siemens Healthcare Diagnostics in May added an anti-cyclic citrullinated peptide IgG assay for rheumatoid arthritis to the test menus of its Immulite 2000/2000 XPi immunoassay systems, and earlier this year added LOCI CA 19-9 and enhanced LOCI vitamin B12 assays to the test menus of its Dimension Vista 1500 and Vista 500 systems, says Marc Redman, vice president of chemistry and immunoassays, Diagnostics Division. Siemens last July introduced its Aptio Automation solution, which connects with the company’s Advia Centaur XP system, Immulite systems, and Dimension integrated systems. Soon Siemens will introduce improved connectivity options for its VersaCell sample-management solution.

For Radiometer’s AQT90 point-of-care immunoassay analyzer, the FDA is reviewing the company’s troponin I submission. Under development are tests for troponin T, BNP, D-dimer, βhCG, CRP, PT-INR, and APTT. When the analyzer was cleared in January 2012, it was available with myoglobin. It received FDA clearance for CK-MB late last year.

Beckman Coulter in January updated the software for its UniCel DxI 600 Access and 800 immunoassay systems. The update adds automatic onboard dilutions for 31 individual assays. Other software improvements are planned for this fall, including extended walkaway times, auto rerun of samples, and new sample probe technology.

CAP TODAY’s immunoassay product guide includes analyzers from these seven companies and 14 more—Abbott Diagnostics, Awareness Technology, The Binding Site, BioMérieux, Bio-Rad Laboratories, Diamedix, DiaSorin, Dynex Technologies, Grifols USA, Hycor Biomedical, Immunodiagnostic Systems, Randox Laboratories, Roche Diagnostics, and Thermo Fisher Scientific. The companies supplied the information. 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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