Roche Diagnostics Korea published PBRTQC research in an intl journal

Samsung Medical Center acquired 217,372 data analysis in a real-world diagnostic setting

In a calcium testing, an analytical shift signal was captured 1 hour and 43 minutes earlier

Confirmed the possibility of early monitoring of changes to diagnostic quality using patient-based real-time quality control (PBRTQC)

High-throughput sample processing in a laboratory.

Roche Diagnostics Korea announced on the 31st that findings from a collaborative study on patient-based real-time quality control (PBRTQC), conducted with the research team in the Department of Laboratory Medicine at Samsung Medical Center, were published in Clinical Chemistry and Laboratory Medicine (CCLM), an international journal dedicated to laboratory medicine.

​This study evaluated the feasibility of applying patient-based real-time quality control to domestic clinical settings to continuously monitor shifts in testing quality using real-world patient test results.  

​Patient-based real-time quality control is a quality assurance methodology that continuously analyzes statistical patterns in real patient test data to detect changes in testing quality.

​While conventional internal quality control (IQC) involves measuring specialized control materials at predefined intervals to verify testing system status, patient-based real-time quality control focuses on examining patient test data streams between scheduled checks to enable the early detection of subtle shifts or anomaly signals.

Previously, relevant research had largely accumulated in overseas settings, leaving limited evidence evaluating its implementation and utility in South Korea's real-world clinical environment. This study is significant because it conducted prospective, real-time monitoring and event-based performance validation within the clinical laboratory of a domestic tertiary general hospital.  

​The research teams from Samsung Medical Center and Roche Diagnostics Korea used Roche Diagnostics' laboratory automation, specimen analysis platforms, and digital solutions to establish analytical protocols tailored to Samsung Medical Center's patient population and testing environment.

​The investigators analyzed 217,372 moving-average quality control values generated from 14 PBRTQC parameter sets. During this process, 1,599 statistical alarms were generated and consolidated into 300 evaluation events, which the investigators then compared with repeat testing results from actual patient specimens and conventional IQC outcomes.

​The study confirmed the feasibility of detecting test result shifts between scheduled IQC runs for select analytes, including calcium, sodium, chloride, and outpatient creatinine.

Notably, for calcium testing, an analytical shift signal was captured 1 hour and 43 minutes earlier than with conventional IQC. This example shows that patient-based real-time quality control can bridge the temporal gap between routine checks and be used to detect subtle variations in assay quality early.  

​Roche Diagnostics Korea explained the study showed the potential for data-driven quality control methods to complement conventional laboratory quality management systems. The company stated that optimizing test items and parameters in alignment with laboratory environments and patient population characteristics enables more continuous quality monitoring.

Professor Hyung-Doo Park, PI of the Department of Laboratory Medicine at Samsung Medical Center, said, "PBRTQC can be used effectively in clinical laboratories if analyte selection and parameter optimization are tailored to institutional patient demographics and testing environments."

Professor Park added, "As the technology advances and is evaluated, PBRTQC is expected to work alongside conventional IQC to strengthen laboratory quality control systems and support continuous quality assurance amid evolving clinical settings."

​Kit Tang, General Manager of Roche Diagnostics Korea, said, "This study was possible because of the collaboration between Roche Diagnostics Korea and Samsung Medical Center under the shared objective of advancing diagnostic testing quality control."

Tang added, "The value of digital technology is in turning data into actionable insights for laboratory specialists and supporting more reliable test results and patient care beyond simple automation."

Tang noted, "Roche Diagnostics Korea will continue collaborating with medical institutions and experts to ensure data-driven innovations foster a safe, smart diagnostic environment and ultimately provide benefits to patients."