Two-centre evaluation of the Abbott CD3500 blood counter

Area of Science:

• Hematology
• Clinical Laboratory Science
• Medical Device Evaluation

Background:

• Automated blood cell counters are essential in modern diagnostics.
• The CD3500 is a 33-parameter analyzer offering a five-part leukocyte differential.
• Evaluating new instruments ensures accuracy and reliability in patient care.

Purpose of the Study:

• To assess the performance of the Abbott CD3500 blood counter.
• To compare its results against established methods (Coulter STKR/STKS and manual counts).
• To evaluate the stability of samples analyzed by the CD3500.

Main Methods:

• Comparison of CD3500 results with Coulter STKR and STKS analyzers.
• Correlation analysis with manual 400-cell differential counts.
• Assessment of sample stability under refrigerated conditions (4°C).
• Evaluation of carryover, mixing efficiency, precision, and flagging rates.

Main Results:

• Excellent correlation for red cell and platelet parameters with Coulter STKR.
• Good correlation for neutrophils, lymphocytes, monocytes, and eosinophils with manual counts and STKS.
• Poor correlation for basophil counts with both manual methods and STKS.
• Satisfactory sample stability for key parameters up to 48 hours.
• Variable false positive flagging rates, with 5.8% of samples showing multiple false flags.

Conclusions:

• The CD3500 demonstrates strong performance for most hematological parameters, comparable to existing systems.
• Basophil counting and specific flag accuracy warrant attention for clinical application.
• The instrument's scatterplot feature offers valuable morphological insights.