HORIBA obtains CE IVDR certification for new Yumizen H500 CRP benchtop hematology analyzer

Original from: HORIBA

HORIBA, a global leader in analytical and measurement technology, has obtained CE IVDR certification for its new Yumizen H500 CRP benchtop hematology analyzer which delivers a simultaneous 5-part extended differential (DIFF) and rapid C-Reactive Protein (CRP) whole blood measurement. Based on its award winning Yumizen H500 compact analyzer, the new instrument is designed for small laboratories and ideal for use in a variety of hospital testing settings for rapid and highly accurate detection of infection and inflammation.

CRP is a highly efficient and sensitive biomarker due to its rapid kinetics, high amplitude variation, early synthesis (6 hours post–infection), short 18-hour half-life and rapid decrease after effective antibiotic-therapy. As CRP also has a narrow normal reference range ( <2 mg/L), it can very effectively detect inflammatory or infectious patient status, even at their first clinical visit. Typically, CRP increases significantly in bacterial infections, but only slightly in viral infections. When CRP measurement is combined with white blood cell (WBC) differentiation, it provides valuable diagnostic insight, helping clinicians better understand the pathology and monitor disease progression or treatment effectiveness.

The new Yumizen H500 CRP’s fast and combined delivery of a complete blood count (CBC), 5-part leukocyte DIFF with CRP from just one single tube (27 µL of venous or capillary blood) significantly decreases turnaround times and costs. Its capillary sampling capabilities are also ideal for Pediatric patients. Providing detailed insights into three immature white blood cell (WBC) populations, the Yumizen H500 CRP offers 38 parameters, including: IML, IMM, IMG, ALY, CRP, plus infectious screening flag options for Malaria and Dengue.

This fast access, from a single tube of whole blood, to quantitative, in-depth leukocyte information alongside CRP values ensures better clinical assessment of complex cases in infectiology, hematology, immunology and oncology. So, the compact Yumizen H500 CRP enables efficient and simple Patient Triage. It can also help to reduce unnecessary antimicrobial treatment, treatment duration, as well as length of hospital stays and costs.

The diagnostic capabilities and clinical value of HORIBA’s new benchtop analyzer are very broad. In addition to detecting inflammatory and infectious diseases using combined 5-part DIFF and CRP testing, it offers a complete red blood cell count, with hemoglobin and platelet analysis, to support rapid diagnosis of anemia and hematological disorders. While its quantitative WBC analysis, including immature forms, provides neutrophil and eosinophil counts for monitoring drug effects and asthma.

Facilitating its fast and user-friendly operation, the Yumizen H500 CRP offers a simplified and intuitive touchscreen interface with color-coded menu and a robust, design. Bidirectional connectivity (ASTM and HL7) means that comprehensive quality control (QC) management is readily accessible, with internal QC indicators, overlapping QC and repeatability testing, as well as HORIBA’s Yumicare remote assistance service – all ensuring optimal and efficient analyzer operation.

“As the first to develop a combined CBC with CRP analyzer in 1998, we’ve drawn on our extensive experience to now introduce our new CE IVDR certified Yumizen H500 CRP, specifically to support enhanced, rapid detection of infection and inflammation from only one single tube,” said George Ferrandi, PharmD, Head of Clinical Chemistry, HORIBA. “Powered by our patented i-DoubleDiff technology, which extends WBC differentiation, and combined with CRP in one robust unit, our latest compact hematology analyzer offers information of greater clinical value on the immune status of a patient. This, and the premium support that we offer through our vast experience of installing over 31,000 units of CBC with CRP analyzers worldwide, sets a new standard for hospital testing.”

Source: HORIBA obtains CE IVDR certification for new Yumizen H500 CRP benchtop hematology analyzer