From Sysmex America, to Beckman Coulter, to Medica, to Siemens and CellaVision, hematology analyzer vendors are beefing up and slimming down their products, focusing on freeing up lab staff, and attending to automation all the while.
Applications that reduce the need for manual differentials and reflex testing—“the most time-consuming steps in the hematology testing process”—are in demand, says Bill Bailey, senior marketing manager at Beckman Coulter Diagnostics. Siemens, too, is seeing heightened demand for systems that “further automate once manual, repetitive, and often error-prone tasks,” thereby freeing up staff for more “critical-care work,” says Michael Noeh, the company’s diagnostics division vice president of global marketing hematology, hemostasis, and specialty business. This trend will continue, adds Alan Burton, Sysmex’s director of hematology marketing, noting that workforce shortages coupled with increased test demand will drive labs to seek solutions that minimize “test-tube touch points” and improve standardization.
To meet this need, Sysmex launched its XN series of automated hematology analyzers in October. In the series are the XN-1000, XN-2000, XN-3000, and XN-9000, all of which appear in this month’s product guide (pages 20–36). All analyzer configurations provide advanced clinical parameters, including nucleated red blood cells with every CBC; immature granulocytes with every differential; reticulocyte hemoglobin count within the reticulocyte profile; and a new fluorescent platelet channel for immature platelet fraction to help physicians with the differential diagnosis of thrombocytopenia.
XN series analyzers were built on Sysmex’s Silent Design concept, which Burton calls a “simplified system of operation and user interface based on careful study of operator interaction with instrumentation and laboratory sample processing.” The design concept, Burton continues, combines a compact, modular system setup and intuitive operation with an expanded parameter menu and a smaller reagent-handling system, minimizing storage-space needs.
Each XN analyzer’s internal processing unit is pre-loaded with customizable decision rules, including automated reflex and rerun rules, so followup actions are based on the lab’s decision criteria and patient population. “These onboard rules harness the combined knowledge contained in the ISLH [International Society for Laboratory Hematology] Consensus Rules and the experience of more than 700 Sysmex WAM middleware user sites,” says Burton, who adds that this automated workflow approach standardizes results review.
Beckman Coulter’s hematology systems, too, provide onboard or middleware decision rules that allow users to autovalidate their test data, Bailey says. One such analyzer is the UniCel DxH 800 Coulter Cellular Analysis System, with which the company paired the automated UniCel DxH Slidemaker Stainer in 2011. Pending FDA approval is a new UniCel DxH software package, which will identify abnormal samples better than the previous version and improve automation and workstation response time, Bailey adds.
Siemens and CellaVision in October signed a supply, distributorship, sales, and service agreement through which Siemens will offer its customers access to CellaVision’s digital microscopy hematology products. Included in the deal, which takes effect Jan. 1, are CellaVision’s DM96 and DM1200 automated medical microscopy analysis systems, both of which are included in the product guide. “Through CellaVision’s flexible software applications, remote users have real-time access to patients’ cell images,” says Siemens’ Noeh.
Available from Siemens since 2008 is the compact Advia 2120i hematology system with Autoslide, which Noeh refers to as Siemens’ “most advanced hematology analyzer yet.” The system automates hematology workflow without using large track-based systems and does not require expensive stains or reflex testing.
New to the hematology analyzers product guide, but available since 2010, is Medica’s EasyCell Assistant. The system, says product manager Ray Morrill, has a 30-position slide autosampler and a separate stat position to allow stat samples to be analyzed immediately. EasyCell “lowers costs by dramatically reducing the technologist time required to perform manual differentials,” Morrill says.
Not yet FDA cleared or in the product guide is Constitution Medical’s Bloodhound Integrated Hematology System. Consisting of a digital image-based cell locator, cell classifier, cell counter, slide maker, and stainer, the analyzer is designed to automatically perform a CBC, five-part WBC differential, and reticulocyte count using digital imaging, says James Linder, MD, the company’s chief medical officer. The system contains a viewing station, “an integrated interactive display that will feature cell galleries of sorted white blood cells, red blood cells, and platelets,” says Dr. Linder. “The system has been designed with the capability to isolate unclassified cells of interest and present them for technologist or pathologist review and classification.”
Constitution plans to conduct clinical trials on the Bloodhound system early next year and submit the results to the FDA shortly thereafter.
Finally, available for the veterinary market (and not in the guide) is Idexx Radil’s ProCyte Dx hematology analyzer, which performs a five-part WBC differential and an absolute reticulocyte count that provides validated results on approximately 31 different blood parameters.
CAP TODAY’s hematology analyzers product guide includes systems from the aforementioned companies and from Abbott Hematology and Horiba Medical. Companies supplied the information listed. Readers interested in a particular system should confirm it has the stated features and capabilities.
Brendan Dabkowski is CAP TODAY associate editor.