Method Validation and Measurement Uncertainty for the Determination of Ethanol in Whole Blood

Abstract

Alcohol intake is known to significantly affect driving ability and there is a positive
correlation between car accidents and Blood Alcohol Concentration (BAC). Alcohol
intake is known to significantly affect driving ability. Therefore, many countries define
and monitor the legal BAC value for drivers. Customers or legal authorities require
determining and reporting the measurement uncertainty in blood alcohol analysis from
laboratories in recent years. To establish the reliability and robustness of the result, the
method was validated and the measurement uncertainty was calculated. A rapid, selective
and quantitative gas chromatography coupled with flame ionisation detection method was
developed and validated for determination of ethanol in whole blood. The method was
validated for selectivity, matrix effect, recovery, linearity, limit of detection (LOD), limit
of quantification (LOQ), recovery, repeatability, reproducibility and robustness. The
validation procedure was designed to be suitable for ISO/IEC 17025 accreditation.
Uncertainty measurements were also determined for the validated method. LOD and
LOQ were found 3.99 mg/dL and 4.30 mg/dL, respectively. The method showed good
linearity in the range of 3.9 to 393.7 mg/dL ethanol with a correlation coefficient (r2 =
0.9999). The method provides fast, precise, simple, robust and unbiased results.