Comparative Testing of In-Clinic, Point-of-Care Hematology Analyzers With a Commercial Laboratory Reference Analyzer.

Area of Science:

• Veterinary Diagnostics
• Clinical Pathology
• Analytical Chemistry

Background:

• Veterinary in-clinic hematology analyzers may exhibit analytical errors.
• Limited research exists on bias correction and its impact on quality goals for these analyzers.

Purpose of the Study:

• Design a comparative testing program for point-of-care (POC) hematology analyzers.
• Evaluate in-clinic analyzer performance against a reference analyzer.
• Assess bias correction for harmonizing results with reference laboratories.
• Determine achievable analytical performance specifications post-bias correction.
• Gauge clinician and technician value of provided quality management data.

Main Methods:

• Utilized fresh canine blood samples within reference limits.
• Processed samples five times on in-clinic analyzers before reference lab analysis.
• Assessed results using total allowable error (TEa) and sigma metrics.
• Calculated quality goal index (QGI) for performance < 4 sigma.
• Reviewed clinical interpretation impact of result differences.

Main Results:

• In-clinic analyzers frequently showed analytical errors, failing quality goals (TEa, sigma metrics).
• Errors were often undetected by in-clinic labs; sigma < 4 indicated poor performance (54% of measurands).
• Bias accounted for 90% of poor-performing instances.
• Bias correction improved in-clinic analyzer performance and facilitated result harmonization.

Conclusions:

• A comparative testing program effectively evaluated and harmonized in-clinic hematology analyzers.
• The program successfully aligned in-clinic results with a reference analyzer using samples within reference intervals.