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Multicenter evaluation of the cobas m 511 integrated hematology analyzer
Author(s) -
Bruegel Mathias,
George Tracy I.,
Feng Bo,
Allen Timothy R.,
Bracco Dan,
Zahniser David J.,
Russcher Henk
Publication year - 2018
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.12903
Subject(s) - hematology analyzer , repeatability , reproducibility , nuclear medicine , medicine , white blood cell , blood smear , hematology , pathology , chromatography , chemistry , malaria
The cobas m 511 integrated hematology analyzer conducts a complete blood count ( CBC ), white blood cell ( WBC ) differential, reticulocyte count, and nucleated red blood cell count using automated digital microscopy. This multicenter study validated the analytical performance of the cobas m 511 system. Methods Repeatability, reproducibility, carryover, mode‐to‐mode comparison, cytomorphology, WBC clinical sensitivity, and method comparison were analyzed at four clinical sites using residual whole blood clinical samples (n = 2546) and fresh whole blood from healthy volunteers (n = 480). For WBC clinical sensitivity, the cobas m 511 system automated CBC and WBC differential, system flags, cobas m 511 images, and stained cobas m 511 slides were compared with manual microscopy. Sysmex ® XN analyzers were used for interinstrument method comparison. Results Repeatability and reproducibility results showed low variability. There was no significant sample carryover and no difference between open/closed modes. The overall percentage agreement of morphology assessments with manual microscopy (n = 163 samples) was 95.6% for cobas m 511 images and 95.7% for cobas m 511 slides. The sensitivity and specificity for detecting distributional and/or morphological abnormalities were 94.4% and 74.6% for cobas m 511 automated differential, and 95.9% and 73.3% for cobas m 511 image assessment, compared with a manual 400‐cell reference differential (n = 439 samples). Some discordance was seen for monocytes and basophils. Correlations between cobas m 511 and Sysmex XN system data were very good (Pearson's R ≥ 0.95 for most CBC parameters). Conclusion The cobas m 511 system performs robustly in the clinical laboratory and is suitable for routine clinical use.