ISO/IEC 17025 Sysmex R-500 hematology reticulocyte analyzer validation.
The Sysmex R-500 (R-500) Hematology Analyzer is a bench-top system appropriate for the analysis of limited batches of blood samples. The R-500 provides percentage proportional (RET%), absolute reticulocyte (RET#), and absolute red blood cell (RBC#) counts. The system was validated at the Doping Control Laboratory of Athens, according to the International Committee for Standardization in Hematology, International Standards Organization (ISO/IEC) 17025, and World Antidoping Agency (WADA) specifications. The instrument calibration was performed according to the manufacturer and validation parameters comprised linearity, precision, uncertainty (intermediate and long-term precision), comparability, effect of drift, carryover, stability, and accuracy. The linearity and the comparability studies for RET#, RET%, and RBC# were expressed in regression factors (R2) and coefficients of correlation [r(x, y)], respectively. For the precision studies, the coefficients of variation for RET#, RET%, and RBC# were 9.49%, 9.83%, and <1.5%, respectively. For the intermediate precision studies, the coefficients of variation for RET#, RET%, and RBC# were 3.1%, 3.6%, and 0.6%, respectively. Carryover was found to be negligible. Sample stability was demonstrated at both room temperature and at 4 degrees C over a 24-hour period. Comparability studies for the R-500 were performed using a Sysmex SE-9500. The total evaluation led to the conclusion that the R-500 is an accurate and precise analyzer and because of to its relatively limited size, it can be considered a portable instrument, capable to be used in sports competition and training sites, where doping control and health tests are conducted. The analytical methodology of RET% measurement by the R-500 has been incorporated into the Doping Control Laboratory of Athens' Scope of Accreditation according to the ISO/IEC 17025 and WADA specifications.
Dimopoulou
H A
HA
Doping Control Laboratory of Athens, Olympic Athletic Center of Athens, Maroussi, Greece.
Theodoridis
T
T
Galea
V
V
Christopoulou-Cokkinou
V
V
Spyridaki
M-H E
MH
Georgakopoulos
C G
CG
D000328:Adult; D003080:Cold Temperature; D004300:Doping in Sports; D004867:Equipment Design; D006801:Humans; D015203:Reproducibility of Results; D017701:Reticulocyte Count / Q000295:instrumentation* / Q000592:standards; D012156:Reticulocytes / Q000648:ultrastructure; D013696:Temperature