Physicians Office Resource Volume 12 Issue 6 - Page 5

said they wanted to avoid travel to more The Sysmex XW-100 Analyzer than one location, and eliminate follow- up visits to discuss test results. The XW-100 Automated Hematology Analyzer is intended for use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential. Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions such as severe anemia and agranulocytosis, who require additional testing. However, it is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients. The analyzer provides a complete blood count and a 3- part differential; a 12 parameter blood component profile as part of an overall • Mean Corpuscular Volume (MCV) patient health assessment. • Platelet Count (PLT) Some in the clinical laboratory • Neutrophil Count (NEUT#) profession have expressed concern that a • Lymphocyte Count (LYM#) waived CBC test now has received FDA • Other White Blood Cell Count clearance. In part, that’s because there (Other WBC#) are examples of waived tests where • Neutrophil Percentage (NEUT%) untrained operators performed tests that • Lymphocyte Percentage (LYM%) produced inaccurate results for reasons • Other White Blood Cell Percentage ranging from an analyzer out of control (Other WBC%) and use of outdated reagents, to failure • MCH (calculateda0 to properly perform quality control. • MCHC(calculated) These experiences are why it is important • RDW-SD (calculated) for Sysmex to tell the story behind the • RDW-CV (calculated) FDA’s clearance of a waived CBC. “Test • MPV (calculated) processes were stripped to the essentials during the design process to meet Key Differences in the New requirements for ease-of-use, and to reduce risk, user error, and erroneous test Sysmex Compared to Moderately Complex Analyzers results” said Ralph Taylor, CEO of • Missing are comprehensive Sysmex America, Inc. reporting, and integration with the LIS and/or EHR. “This was by The CBC and Three-Part Differential: design,” noted Taylor. The FDA uses a 15 µL sample of venous blood to clearance as a waived test allows provide clinically useful results.  operators in CLIA-waived facilities to operate the system. Analyses include: • The Sysmex XW-100 has several • White Blood Cell Count (WBC) innovative features. “This benchtop • Red Blood Cell Count (RBC) analyzer requires no additional • Hemoglobin (HGB) training to set up upon arrival,” • Hematocrit (HCT) “ Our goal with this analyzer is to deliver information within the POL environment that allows clinicians to respond quickly and rapidly to begin treatment.” Ralph Taylor, CEO, Sysmex America, Inc. explained Taylor. “Operator training consists of a brief video outlining basic features. Everything el se is handled through onscreen prompts that walk operators step- by-step through the initial data- entry processes and starting the CBC test. “When started, the analyzer connects to Sysmex to verify reagent authenticity and expiration dates, and check control values,” he continued. “The instrument also stays connected to Sysmex and rechecks these after every eight hours of laboratory use, and when reagents are changed” • Unlike more complex hematology analyzers, this system does not report to Sysmex outside of routine data checks. It also does not transmit data locally within the healthcare setting. Instead, it produces paper printouts of CBC and three-part differential results, which the physician uses to support diagnosis and treatment decisions. In addition to the print-out, the XW-100 stores the results of the last 100 tests on a first-in/first-out basis. 5