Hematology analyzers (GA) are complex laboratory equipment that is designed to determine blood parameters that are diagnostically important in clinical practice. Verification of hematology analyzer by end-user laboratory after initially validation by manufacturer is the main method to measure analytical characteristics and evaluate the performance, advantages and limitations of HA.

AIM

To evaluate and verify analytical characteristics of hematology analyzer Yumizen H-500 prior to reporting of results.

MATERIAL AND METHODS

The basic analytical characteristics, including morphology flagging, of the Yumizen H-500 were evaluated and compared with the XN-3000 (Sysmex) data and manual analysis. In this study 145 samples (400 measurements) were enrolled.

RESULTS

The authors successfully verified most analytical characteristics of Yumizen H-500. Yumizen H-500 showed good analytical performance (precision, linearity and accuracy). We found the only limitations — high imprecision at the very low level for platelets (less 12·10⁹/l) and WBC count (less 0.15·10⁹/l). Our study demonstrates the absence of critical carry-over for verified instrument. Results from the Yumizen H-500 were highly correlated with those obtained from similar tests performed on Sysmex XN-3000 (all R² coefficients were close to 1 except basophil cells and large immature cells). The abnormal cell flags by Yumizen H-500 have the next sensitivity and specifity: 46.7% and 92.3% for LIC, 60.0% and 98.3% for Left shift, 66.7% and 83.1% for Platelets aggregates or NRBC, accordingly.

CONCLUSION

Obtained data demonstrate that analyzer Yumizen H-500 is a good candidate instrument for our purpose and laboratory’s specific patient population.