|
|
Background: Systematic performance verification is required before a laboratory can introduce a new measurement procedure for reporting results of patient testing. The aim of this study was to determine whether a new Iris iQ200 Sprint automated urine microscopy analyzer (iQ200 Sprint) could be incorporated into our routine laboratory.
Methods: A total of 421 fresh urine samples were selected from the Affiliated Hospital of Nantong University, including those from healthy individuals and those with a variety of abnormalities to ensure a wide range of results. Precision, recovery, carry-over, linearity and reference interval were verified according to well-established protocols.
Results: The repeatability studies found coefficients of variability (CVs) in the range of 10.53% - 20.28% for red blood cells, white blood cells, and squamous epithelial cells, while the CV for the iQ Positive Control sample was 3.23%. The relative bias was 0.5% for the iQ Positive Control sample and no carry-over was detected. Linearity was observed at concentrations of 10 - 2069.5 particles/μL (y = 0.989x + 9.1, R2 = 0.999). The manufacturer’s claimed reference interval meets the requirements for medical usefulness.
Conclusions: Performance verification is needed before a clinical laboratory can introduce a new measurement procedure. The iQ200 Sprint is sufficiently precise and reliable to be applied in our clinical laboratory.
DOI: 10.7754/Clin.Lab.2017.170318
|
