Clinical laboratory · 2017
Performance Verification of the Iris iQ200 Sprint Automated Urine Microscopy Analyzer in a Hospital Routine Laboratory.
Оценочное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Cui Ming, Ju Shaoqing, Shi Yingjuan, Jing Rongrong
Аннотация
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.
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.