Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions

摘要

ObjectivesDeviation from manufacturers’ pre-analytical sample handling recommendations necessitates extensive validation studies. This report uses plasma lactate testing, where a recommended 15?min room temperature sample handling limit cannot be met by the clinical laboratory, as an example for studies to bridge the gap with practice.Design and MethodsTriplicate blood samples were collected from patients (n?=?51) with lactate requests by clinicians and from normal volunteers (n?=?50). One tube was transported on ice (4?°C), the others were maintained at room temperature (23?°C). Tubes stored at 4?°C were processed at 30?min from collection. Tubes stored at 23?°C were processed at 15 and at 30?min from collection. Lactate levels were measured using Roche Diagnostics Cobas 6000? analyzer.ResultsLactate levels in normal subjects ranged from 0.6 to 3.1?mmol/L (median 1.1). Patient lactate levels ranged from 0.8 to 26.3?mmol/L (median 2.2). Bias in lactate levels following extended storage of samples from both normal subjects and patients ranged from ??1.3 to2.2 and from ??1.0–1.0?mmol/L when stored for 30?min at 23?°C or at 4?°C, respectively. The bias between lactate levels at 30?min at 23?°C and 4?°C was ??1.2 to ??0.5?mmol/L for both populations. Although the bias was not statistically significant for all variables, a clinically significant (>0.2?mmol/L) bias was observed in 28% of normal and 7.0% of patient samples.ConclusionExtending the pre-analytical time to 30?min at 23?°C did not significantly impact clinical utility of lactate measurement in our patient population.