Matrix-matched low-concentration internal quality control detects high-sensitivity cardiac troponin T errors missed
Yao Lei1, Xiaosheng Duan1, Jian Xu1
1Department of Laboratory Medicine and Sichuan Provincial Key Laboratory for Human Disease Gene Study, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610072, China.
Talanta
|March 28, 2026
Summary
A new pooled serum internal quality control (IQC) effectively monitors low-concentration high-sensitivity cardiac troponin T (hs-cTnT) at the 99th percentile upper reference limit (URL). This cost-effective method improves acute coronary syndrome diagnosis accuracy and reduces laboratory expenses.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Quality Control in Diagnostics
Background:
- High-sensitivity cardiac troponin T (hs-cTnT) is crucial for acute coronary syndrome (ACS) diagnosis, with the 99th percentile upper reference limit (URL) as a key threshold.
- Commercial quality control (QC) materials often lack adequate coverage at these critical low concentrations, potentially impacting assay reliability.
Purpose of the Study:
- To develop a stable, cost-effective pooled serum internal quality control (IQC) material for hs-cTnT targeting the 99th percentile URL.
- To evaluate the feasibility of this self-prepared IQC for routine QC monitoring and its effectiveness in detecting analytical errors.
Main Methods:
- Preparation of a low-concentration IQC from pooled patient serum.
- Assessment of IQC homogeneity and long-term stability.
- Comparison of the self-made IQC with commercial controls in detecting simulated calibration shifts and during 12-month routine implementation.
Main Results:
- The self-made IQC demonstrated good homogeneity and 12-month stability (CV 4.1%).
- It proved more effective than commercial controls in detecting simulated calibration errors and identified two critical out-of-control events missed by commercial materials.
- Implementation resulted in a 71.1% cost reduction (annual net saving ¥13,737).
Conclusions:
- A self-prepared low-concentration IQC from pooled serum is a stable, cost-effective option for hs-cTnT monitoring at the 99th percentile URL.
- This approach enhances quality assurance at clinically critical low concentrations, supporting the analytical reliability of hs-cTnT assays for ACS diagnosis.
