Road to automated urinalysis analyzer: Validation of Sysmex UN-3000 to supplant manual urinalysis

Abstract Introduction/Objective Traditionally, urinalysis encompasses the chemical analysis of urine by dipstick and manual microscopy for formed elements. High specimen volume and varying subjectivity among individuals performing microscopic analysis make the practice both imprecise and inefficient. Implementation of Sysmex UN- Series™Automated Urinalysis (Sysmex Corporation, Kobe, Japan) fulfilled our need for automation, addressing both issues at hand. Automated urinalysis offers a solution for laboratories to meet the growing demand for faster result turn around times(TAT) with ever increasing specimen volumes. We expect greater sensitivity and reproducibility in terms of comparison to manual microscopy, as well as quicker TAT with the change in methodology. Methods/Case Report Using both unpreserved and preserved urine tubes, a macroscopic comparative study between Clinitek Advantus(manual) and Clinitek Novus (automated) methods was carried out on 141 urines with greater than 60 abnormal patients. Similarly, a microscopic study between the laboratory’s manual microscopy procedure and the Sysmex UF-5000 was carried out on 112 urines with greater than 60 abnormal patients. RBCs, WBCs, Epithelial cells were evaluated under high power field(40X); casts and crystals were evaluated under lower power field(10X). The Reference Range Interval for both chemical and microscopic was verified using 44 normal patient specimens. The quantified values are converted to high and low power field (hpf/lpf), analogous to the current system in the laboratory. Results (if a Case Study enter NA) Most parameters had >90% agreement between manual and automated method. Parameters falling below 90% were checked to see if discrepancies fell within 1 degree. Automated system is more sensitive than manual and our average TAT for urinalysis dropped 50%. Conclusion The automated urinalysis technology enabled us to focus only on samples requiring intervention based on pathological criteria, resulting in reduced overall TAT and workload burden, and improved consistency in reporting across specimens.