Analytical performance evaluation and the 99th percentile reference limit study of a rapid whole blood
Yuhong Yue1, Jingjing Xiang2, Wenxuan Fu2
1Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing Center for Clinical Laboratories, Beijing, China; Beijing Center for Clinical Laboratories, Beijing, China.
Insights
A new rapid whole blood high-sensitivity cardiac troponin T (hs-cTnT) assay shows strong analytical performance. This assay can help rapidly rule out acute myocardial infarction (AMI) in emergency settings.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Biomarker Assay Development
Background:
- Evaluating novel diagnostic assays is crucial for improving patient care.
- High-sensitivity cardiac troponin T (hs-cTnT) is a key biomarker for diagnosing acute myocardial infarction (AMI).
- Rapid point-of-care testing can expedite emergency department workflows.
Purpose of the Study:
- To assess the analytical performance of a new rapid whole blood hs-cTnT assay.
- To establish the 99th percentile upper reference limit (URL) for healthy individuals using this assay.
- To determine the clinical utility of the assay for rapid AMI exclusion.
Main Methods:
- Analytical performance was evaluated using Clinical and Laboratory Standards Institute (CLSI) guidelines.
- Key performance metrics included imprecision, LoB, LoD, LoQ, linearity, and whole blood-plasma equivalence.
- Sex-specific 99th percentile URLs were determined through nonparametric analysis of healthy volunteers.
Main Results:
- The assay demonstrated excellent linearity (R²=0.999) and comparability (R²=0.995) with existing methods.
- Low limits of detection (LoD=1.2 ng/L) and quantitation (LoQ=2.8 ng/L) were achieved.
- Sex-specific 99th percentile URLs were established: 16.8 ng/L for males, 8.9 ng/L for females, and 15.2 ng/L for total population.
Conclusions:
- The rapid whole blood hs-cTnT assay exhibits robust analytical performance.
- Established sex-stratified 99th percentile URLs support its potential clinical use.
- The assay may facilitate rapid exclusion of AMI in emergency settings.
Background:
This study aimed to comprehensively evaluate the analytical performance of a novel rapid whole blood hs-cTnT assay and establish 99th percentile upper reference limit (URL) for healthy individuals.
Methods:
The imprecision, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), linearity, comparability and whole blood-plasma equivalence were evaluated according to the Clinical and Laboratory Standards Institute guidelines. The sex-specific 99th percentile URL was established via nonparametric analysis of healthy volunteers.
Results:
The within-run CVs were 2.3% at low concentration 5.7 ng/L, 1.8% at high concentration 13.9 ng/L and 1.8% at high concentration 137.0 ng/L; between-run CVs were 1.0%, 1.3% and 1.8%, respectively. LoB and LoD were 0.7 and 1.2 ng/L, respectively, and LoQ for whole blood samples was 2.8 ng/L at 10% CV. The results met the requirements of linearity and the correlation coefficient was 0.999. Comparability analysis against the Roche® showed good agreement with R2 = 0.995. Whole blood-plasma equivalence was a mean ratio of 0.944 (95% limits of agreement ratio: 0.929 to 0.958), with a correlation coefficient R2 of 0.961. The 99th percentile URL for whole blood samples was 16.8 ng/L for males, 8.9 ng/L for females, and 15.2 ng/L for total. The hs-cTnT detection rate of all observed healthy individuals from LoD to 99th was 97.6%, and 95.3% for the males, 100% for the females.
Conclusions:
The rapid whole blood high-sensitivity cardiac troponin T (hs-cTnT) assay demonstrated robust analytical performance. Its sex-stratified and age-stratified 99th percentile URLs provided preliminary support for its potential clinical utility in the rapid exclusion of the diagnosis of acute myocardial infarction (AMI) in emergency settings.
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