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Interlaboratory comparison of the Doumas bilirubin reference method.
Stanley F Lo1, Hans-Joachim Kytzia, Gerhard Schumann
1Department of Pathology, Medical College of Wisconsin, Milwaukee, USA. slo@mcw.edu
Clinical Biochemistry
|May 26, 2009
Summary
The Doumas bilirubin reference method demonstrates robust and reproducible performance, with inter-laboratory coefficients of variation between 1-3%. This validates its use for developing accurate bilirubin calibrators.
Area of Science:
- Clinical Chemistry
- Biochemistry
- Laboratory Medicine
Background:
- Accurate bilirubin measurement is crucial for diagnosing and managing conditions like neonatal jaundice.
- Reference methods are essential for standardizing bilirubin assays and ensuring reliable diagnostic results.
Purpose of the Study:
- To evaluate the performance and reliability of the Doumas bilirubin reference method.
- To determine the reproducibility and accuracy of the Doumas method across multiple laboratories.
Main Methods:
- Inter-laboratory ring trials were conducted using pooled patient specimens.
- Human sera were enriched with unconjugated bilirubin and analyzed.
- The Doumas bilirubin reference method was employed in five independent laboratories.
Main Results:
- The Doumas method exhibited excellent reproducibility, with coefficients of variation ranging from 1-3% across the linear measurement range.
- Consistent results were obtained between participating laboratories, indicating method robustness.
Conclusions:
- The Doumas bilirubin reference method is a robust and reproducible assay.
- The method's performance supports its application in developing improved and dependable bilirubin calibrators.
- This reference method can enhance the accuracy of clinical bilirubin testing.
