Multicentre verification of haematology laboratory blood collection tubes during a global blood collection tube shortage.

Abstract

Verification of blood collection tubes is essential for clinical laboratories. The aim of this study was to assess performance of candidate tubes from four alternative suppliers for routine diagnostic haematology testing during an impending global shortage of blood collection tubes. A multicentre verification study was performed in Cape Town, South Africa. Blood from 300 healthy volunteers was collected into K2 EDTA and sodium citrate tubes of BD Vacutainer® comparator tubes and one of four candidate tubes (Vacucare, Vacuette®, V-TUBE™ and Vacutest®). A technical verification was performed, which included tube physical properties and safety. Routine haematology testing was performed for clinical verification. Vacucare tubes did not have a fill-line indicator, Vacuette® tubes had external blood contamination on the caps post-venesection and Vacutest® tubes had hard rubber stoppers. K2 EDTA tubes of Vacuette®, Vacucare and Vacutest® performed similarly to the comparator. Unacceptable constant bias was seen for PT in Vacucare (95% CI -2.38 to -0.10), Vacutest® (95% CI -1.91 to -0.49) and Vacuette® (95% CI 0.10-1.84) tubes and for aPTT in Vacuette® (95% CI 0.22-2.00) and V-TUBE™ (95% CI -2.88 to -0.44). Unacceptable %bias was seen for aPTT in Vacucare (95% CI 2.78-4.59) and Vacutest® tubes (95% CI 2.53-3.82; desirable ±2.30), and in V-TUBE™ for mean cell volume (95% CI 1.15-1.47, desirable ±0.95%) and mean cell haemoglobin concentration (95% CI -1.65 to -0.93, desirable ±0.43%). Blood collection tubes introduce variability to routine haematology results. We recommend that laboratories use one brand of tube. Verification of new candidate tubes should be performed to ensure consistency and reliable reporting of results.