Multicenter evaluation of the cobas m 511 integrated hematology analyzer

International Journal of Laboratory Hematology
Mathias BruegelHenk Russcher

Abstract

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. 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. 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 a...Continue Reading

References

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Citations

Jul 5, 2019·International Journal of Laboratory Hematology·Kwang-Sook WooJin-Yeong Han
Jul 25, 2019·Clinical Chemistry and Laboratory Medicine : CCLM·Christiaan L SlimHuibert Storm
Jul 16, 2019·International Journal of Laboratory Hematology·Yolien Van der BekenKristin Jochmans
May 3, 2019·International Journal of Laboratory Hematology·Alexander KratzUNKNOWN International Council for Standardization in Haematology
Nov 3, 2020·Cytometry. Part a : the Journal of the International Society for Analytical Cytology·Oliver Hayden, Christian Klenk
Feb 9, 2021·Clinical Chemistry and Laboratory Medicine : CCLM·Johannes J M L Hoffmann
Jul 16, 2021·American Journal of Hematology·Neta BacharCarlo Brugnara

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