Patient-based pre-classified real-time quality control (PCRTQC)

Area of Science:

• Clinical Laboratory Science
• Analytical Chemistry
• Medical Diagnostics

Background:

• Patient-based real-time quality control (PBRTQC) is increasingly used in clinical laboratories.
• Traditional quality control methods have limitations, prompting research into enhanced protocols.
• The performance and practical application of PBRTQC require further investigation and refinement.

Purpose of the Study:

• To introduce and evaluate patient-based pre-classified real-time quality control (PCRTQC) as an enhanced quality control protocol.
• To improve the accuracy and efficiency of real-time quality control in clinical chemistry analysis.
• To address the interference from diverse patient types in quality control measures.

Main Methods:

• The study utilized patient test results from a clinical chemistry analyzer in 2021.
• The OPTICS algorithm was employed for a patient pre-classification step to reduce inter-individual variation.
• Constant error (CE) and proportional error (PE) were simulated, and metrics like probability for false rejection (Pfr) and average number of patient samples until error detection (ANPed) were measured for four analytes.

Main Results:

• Patient-based pre-classified real-time quality control (PCRTQC) demonstrated superior performance compared to regression-adjusted real-time quality control (RARTQC).
• PCRTQC achieved approximately 50% improvement in the average number of patient samples until error detection (ANPed) for both constant error (CE) and proportional error (PE).
• These improvements were particularly notable when considering the total allowable error threshold.

Conclusions:

• The pre-classification step in PCRTQC effectively minimizes inter-individual variation, enhancing data preprocessing, filtering, and modeling.
• PCRTQC provides a robust framework for advancing real-time quality control research in clinical laboratories.
• The findings support the adoption of PCRTQC for more reliable and efficient laboratory diagnostics.