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

Alcohol intake is known to significantly affect driving ability and there is a relationship between Blood Alcohol Concentration (BAC) and the risk of road traffic accidents car accidents. 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. In order to ensure the reliability and safety of the result, the method was validated and the measurement uncertainty was calculated. A rapid, selective and robust gas chromatography coupled with flame ionisation detection method was developed and validated for the quantitative determination of ethanol in whole blood. The method was validated for selectivity, matrix effect, recovery, and linearity, limit of detection (LOD), limit of quantification (LOQ), recovery, repeatability, reproducibility and robustness. The validation procedure was designed to be suitable for ISO 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.

Keywords:

Whole Blood, Ethanol, HS-GC/FID, Validation Uncertainty,

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