Developing chemistry and immunoassay analyzers for low-volume labs and the point of care is like developing athletes—companies and coaches alike need to stress the fundamentals while focusing on the big picture. And that is the modus operandi of the analyzer manufacturers in this month’s product guide.
Roche Diagnostics, for instance, continues to enhance the functionality of its Cobas 4000 analyzer series, which includes the Cobas c 311 low-volume chemistry solution and Cobas e 411 immunochemistry analyzer, while focusing on product growth. To streamline workflow and increase productivity, says marketing manager Mahbod Aziminia, the 4000 series shares a common interface and reagents with the company’s mid- and high-volume systems, allowing health care networks to pool resources and simplify inventory. It allows an operator to “move from the core lab to, say, a small satellite lab without having to relearn the instrument software,” he explains.
Roche recently added to its software auto-masking, a feature whereby analyzers can mask control and patient sampling for a test if test calibration fails. Another new feature is “scan before sample stop,” which allows the software to automatically process additional tests.
New from MedTest DX, formerly Polymedco, is the Poly-Chem 90 automated clinical chemistry analyzer. Displayed at the American Association for Clinical Chemistry’s annual meeting in July and FDA 510(k) cleared recently, the benchtop system runs up to 90 tests per hour and has a built-in LCD touchscreen and refrigerated onboard reagents, says company CEO James White. Also available from Med-Test DX is the Spot-chem EZ platform for stat and physician office labs, which processes up to 48 samples per hour, and the Poly-Chem 180 system, which processes up to 450 tests per hour.
Another system appearing at the AACC meeting was Carolina Liquid Chemistries’ CLC 480 chemistry analyzer, which is scheduled for release early next year. The benchtop unit is for the stat lab, special chemistry lab, physician office lab, or small hospital, says vice president of marketing and sales Patricia A. Shugart. The CLC 480 processes 400 tests per hour and can run basic panels as well as drugs of abuse.
EliTech Clinical Systems recently received FDA 510(k) clearance for its Selectra ProM chemistry system, which runs 266 tests per hour, says vice president of North American marketing and sales Abe Gutman. The Selectra ProM and Selectra ProS systems feature icon-driven operator interfaces, positive sample identification, and automated reagent programming and tracking. The Pro series systems include a line of liquid-stable, ready-to-use reagents. The company plans to add throm-boxane and hyaluronic acid assays to the product line.
Siemens Healthcare Diagnostics’ newest offering is the Dimension EXL 200 integrated chemistry/immunoassay system, which was introduced in March and features LOCI advanced chemiluminescence technology. The analyzer provides more than 90 percent of the critical tests ordered by physicians, says Dave Hickey, CEO of chemistry, immunoassay, automation, and diagnostics IT. The system includes a cardiac stat menu and can provide troponin I results in 10 minutes. Hickey predicts that customers will continue to demand more automated capabilities, such as sample integrity testing for common interferents and clot detection.
New from Nova Biomedical is the Stat Profile pHOx Ultra analyzer. The system’s onboard data-management solution allows bidirectional networking, data capture, and extensive reporting capabilities from multiple field units, says product manager Brad Bullen. Data can be uploaded and managed by one pHOx Ultra system designated as the “command” analyzer, Bullen continues, eliminating the need for multiple LIS/HIS interfaces and delays related to technology integration.
Finally, still available from Alfa Wassermann are the ACE and ACE Alera clinical chemistry systems, says director of laboratory information systems sales and marketing Scott Lavine. The Health Information Technology for Economic and Clinical Health Act, through which health care providers receive incentives for adopting electronic medical records, is increasing demand for more connectivity solutions in the point-of-care and near-patient testing markets, Lavine adds.
CAP TODAY’s guide to chemistry and immunoassay analyzers for low-volume labs and the point of care includes products from the aforementioned manufacturers and from Abaxis, Abbott Point of Care, AMS Diagnostics, Awareness Technology, Beckman Coulter, Horiba Medical, Medica Corp., Ortho-Clinical Diagnostics, Randox Laboratories, SDI Biomed, 3M, and Vital Diagnostics. Vendors 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.