Pre-Analytical Within-Laboratory Evacuated Blood-Collection Tube Quality Evaluation

Abstract

Pre-analytical steps contribute to an overall quality of the results of laboratory trials. The volume of blood drawn into the blood-collection tube and the anticoagulant amount introduced into the tube during its production should ensure the anticoagulant level in the recommended range; otherwise, the results can be altered. In evacuated blood-collection tubes, the internal under-pressure at the instant of the blood specimen collection affects the draw volume. During the shelf life, the internal under-pressure deteriorates. With no testing procedures in place, inappropriate anticoagulant levels can pass unnoticed. The chapter details testing procedures ensuring that the tubes are used only if, and only until, they are of the adequate quality. The reasoning behind the methodology is fully explained, and the case studies of the quality evaluations are discussed.

Accuracy of Citrate Anticoagulant Amount, Volume, and Concentration in Evacuated Blood Collection Tubes Evaluated with UV Molecular Absorption Spectrometry on a Purified Water Model

“…Noncompliance with the H1-A5 standard [ 20 ] regarding exceeding EDTA anticoagulant concentrations was much more frequent. We wished for a similar methodology to be developed for citrate tubes but recognised them as a distinct and much more challenging case [ 21 , 22 ].…”

“…Anticoagulant, if not present in a dry form, has a negligibly small volume in comparison with V int . A study of the change in the draw capacity of the tubes of different producers during the time was possible [ 22 ].…”

“…Draw volume was measured in Ljubljana at an altitude of 300 m with a 5-mL Bang burette filled to the mark with Milli-Q water. The experimental technique was more precisely described elsewhere [ 21 , 22 ]. The nonreduced air pressure varied between 972 and 994 hPa, and the ambient temperature was (24 ± 1) °C.…”

“…The titrimetric method suggested by the standard [ 20 ] is only suitable for the quality control of a bulk anticoagulant solution before it enters the production process. Conductometry, by which we enabled quality evaluation of K2EDTA and K3EDTA tubes [ 21 , 22 ], is not applicable since buffered and unbuffered citrate differ in chemical equilibrium forms [ 23 , 24 ]. In addition to the appropriate analytical method, the upgraded methodology is necessary since citrate tubes have several additional sources of uncertainty if compared to EDTA tubes.…”

Preanalytical Quality Evaluation of Citrate Evacuated Blood Collection Tubes—Ultraviolet Molecular Absorption Spectrometry Confronted with Ion Chromatography

“…Comparability should be statistically confirmed on human samples. The drawing capacity of the tubes changes over time [3,4]. In addition to other sources of uncertainty, this affects the citrate anticoagulant concentration.…”