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Published on: February 10, 2020
Hemolysis Affects C-Peptide Immunoassay
Zhi-Qi Wu1, Ju Lu1, Hua-Guo Xu2
1Department of Laboratory Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.
Insights
Hemolysis significantly impacts C-peptide measurements, affecting its accuracy as a marker for insulin secretion. An individualized correction equation was developed to ensure accurate C-peptide results from hemolyzed samples.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Diabetes Mellitus Research
Background:
- C-peptide is a crucial marker for insulin secretion and is implicated in coronary artery disease (CAD) development in type 2 diabetes mellitus (T2DM).
- Previous research suggested C-peptide assays are unaffected by hemolysis, but routine practice revealed otherwise.
- Hemolysis was observed to negatively interfere with C-peptide measurements in laboratory settings.
Purpose of the Study:
- To investigate the impact of hemolysis on C-peptide assay accuracy.
- To develop and validate an individualized correction equation for C-peptide measurements in hemolyzed samples.
- To improve the reliability of C-peptide testing in routine clinical practice.
Main Methods:
- Studied hemolysis effects by adding lysed red blood cells to serum samples.
- Derived an individualized correction equation based on hemolysis parameters.
- Evaluated the derived equation's performance using artificially hemolyzed samples.
Main Results:
- C-peptide concentration demonstrated a decrease with increased hemolysis degree and duration.
- An individualized correction equation (C-Pcorr = C-Pmeas /(0.969-1.5Hbserum/plasma -5.394 ×10-5 Time)) was established.
- The equation effectively corrects for C-peptide measurement bias caused by hemolysis.
Conclusions:
- Hemolysis adversely affects C-peptide measurements.
- The developed individualized correction equation enables accurate reporting of C-peptide in hemolyzed samples across various hemolysis degrees.
- Implementing this correction enhances diagnostic accuracy and prevents suboptimal treatment decisions.
Background:
C-peptide is used widely as a marker of insulin secretion, and it participates in the inflammatory response and contributes to the development of coronary artery disease (CAD) in patients with type 2 diabetes mellitus (T2DM). Previous studies have reported that C-peptide measurement was unaffected by hemolysis. However, we found that hemolysis negatively affected C-peptide assay in routine laboratory practice. We further established and validated an individualized hemolysis correction equation to correct and report accurate serum C-peptide results for hemolyzed samples.
Methods:
We studied the effects of hemolysis on C-peptide assay by adding lysed self red blood cells (self-RBCs) to serum. An individualized correction equation was derived. Further, we evaluated the performance of this individualized correction equation by artificially hemolyzed samples.
Results:
C-peptide concentration decreased with increasing degree and exposure time of hemolysis. The individualized hemolysis correction equation derived: C-Pcorr = C-Pmeas /(0.969-1.5Hbserum/plasma -5.394 ×10-5 Time), which can correct bias in C-peptide measurement caused by hemolysis.
Conclusions:
Hemolysis negatively affects C-peptide measurement. We can correct and report accurate serum C-peptide results for a wide range of degrees of sample hemolysis by individualized hemolysis correction equation for C-peptide assay. This correction would improve diagnostic accuracy and reduce inappropriate therapeutic decisions.
