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Clinical performance of the EMIT vancomycin assay
K T Yeo1, W Traverse, G L Horowitz
1Department of Pathology, Charles A. Dana Research Institute, Boston, MA.
Clinical Chemistry
|July 1, 1989
Summary
The EMIT vancomycin assay shows marginal precision above 30 mg/L and a proportional bias, especially in patients with high creatinine. Caution is advised when using this system.
Area of Science:
- Clinical Chemistry
- Analytical Toxicology
Background:
- Vancomycin therapeutic drug monitoring is crucial for patient outcomes.
- Accurate and precise assays are essential for reliable vancomycin level determination.
Purpose of the Study:
- To evaluate the performance of the EMIT vancomycin assay on the Cobas Bio centrifugal analyzer.
- To identify potential clinical limitations of the EMIT vancomycin assay.
Main Methods:
- Comparison of EMIT vancomycin assay results with fluorescent polarization immunoassay (TDx).
- Assessment of assay precision at various vancomycin concentrations.
- Analysis of proportional bias and its correlation with creatinine levels.
Main Results:
- The EMIT system demonstrated acceptable precision up to 30 mg/L, but marginal precision above this concentration.
- A good correlation (r = 0.971) was observed between EMIT and TDx, with a proportional bias described by [EMIT] = (0.877)[TDx] + 0.435 mg/L.
- Proportional bias was significantly more pronounced in specimens with elevated creatinine levels.
Conclusions:
- The EMIT vancomycin assay exhibits imprecision at higher concentrations and a notable proportional bias, particularly in patients with renal impairment.
- Clinical use of the EMIT vancomycin system requires caution, especially in populations with high creatinine values.
- Further studies are needed to ascertain the accuracy of the EMIT assay relative to other methods.