Platelet count evaluation compared with the immunoplatelet reference method and performance evaluation of the...

Area of Science:

• Hematology
• Clinical Diagnostics
• Laboratory Medicine

Background:

• The Celltac G hematology analyzer features new sheath flow control technology to enhance platelet count (Plt) accuracy.
• Clinical evaluation compared the Celltac G against Sysmex XN-9000 and Abbott CELL-DYN Sapphire analyzers.
• Accuracy was benchmarked against the immunoplatelet reference method (FCM-Ref).

Purpose of the Study:

• To clinically evaluate the performance of the Celltac G hematology analyzer.
• To assess the comparability of Celltac G platelet counts with other automated analyzers.
• To determine the accuracy of Celltac G against a reference method.

Main Methods:

• Repeatability, within-laboratory imprecision, and carryover were assessed using clinical samples and control materials.
• Method comparison involved 388 samples across three analyzers.
• Platelet count accuracy was specifically evaluated using 54 samples, including those with low counts (<50x10⁹ /L).

Main Results:

• The Celltac G exhibited sufficient performance regarding imprecision, carryover, and comparability.
• Analytical Measurement Interval (AMI) and linearity for platelet counts were validated.
• All compared analyzers showed some degree of disagreement with the immunoplatelet reference method.

Conclusions:

• The Celltac G hematology analyzer is suitable for clinical laboratory use.
• The study highlights the need for clinical laboratories to establish reportable measurement intervals (RMI) for platelet counts.
• Accurate reporting of platelet counts from multiple analyzers requires careful consideration of measurement intervals.