Reduced bracketed control concept for automated biochemistry analyzers: A reliable and cost-effective setup

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Analytical Biochemistry

Background:

• Automated analyzers are standard for biochemical analyte production.
• Internal quality control (IQC) typically uses critical and bracketed controls (BC).
• Quality control materials are costly, prompting investigation into reduced BC protocols.

Purpose of the Study:

• To evaluate the reliability of a reduced bracketed control (rBC) for detecting clinically relevant analytical issues.
• To compare the efficacy of an rBC against a full bracketed control (fBC).

Main Methods:

• A comparative study over 8 months.
• An rBC with nine analytes and one IQC level was compared to a full BC (fBC) with 65 analytes and two IQC levels.
• Analysis focused on revealed analytical problems and corrected patient results.

Main Results:

• Over 1.4 million patient results were analyzed.
• The fBC and rBC led to reanalysis of 1669 and 996 samples, correcting 311 and 222 patient results, respectively.
• The rBC overlooked 89 patient results outside correction limits, with only two deemed clinically significant, at an approximate annual cost saving of €220,000.

Conclusions:

• A reduced bracketed control (rBC) is reliable for detecting most clinically important analytical errors.
• The rBC strategy significantly reduces costs associated with quality control.
• Further optimization may involve incorporating critical tests not suitable for patient-based real-time QC into the rBC.