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Assessment of interlaboratory performance in external proficiency testing programs with a direct HDL-cholesterol
N Rifai1, T G Cole, E Iannotti
1Department of Laboratory Medicine, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA.
Clinical Chemistry
|July 17, 1998
Summary
New direct HDL-cholesterol (HDL-C) assays offer precise measurement with small sample volumes. This study validates a direct HDL-C assay, showing excellent agreement with reference methods and meeting regulatory standards.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Cardiovascular Diagnostics
Background:
- Traditional HDL-cholesterol (HDL-C) methods involve precipitation, which can be affected by high triglyceride levels.
- Direct HDL-C assays offer potential advantages in precision and reduced interference.
Purpose of the Study:
- To evaluate the inter- and intralaboratory variability of a specific direct HDL-C assay.
- To assess the assay's performance in external proficiency testing surveys.
- To compare the direct HDL-C assay with established reference methods.
Main Methods:
- A comparison study involving three laboratories, different analyzers, and 85 serum specimens.
- Validation against ultracentrifugation-dextran sulfate-Mg2+ and Cholesterol Reference Method Laboratory Network methods.
- Performance evaluation in external proficiency testing programs (CAP, ALERT, CDC Lipid Standardization).
Main Results:
- High correlation (r=0.99) among laboratories using different analyzers.
- Excellent agreement with reference methods (r=0.98 for both).
- Total error within acceptable limits (-0.8% to +11.1%) at medical decision levels.
Conclusions:
- The evaluated direct HDL-C assay demonstrates high precision and accuracy.
- The assay meets performance criteria for regulatory agencies and external quality assessments.
- Direct HDL-C assays are a reliable alternative to traditional methods for clinical use.