Mitigating the risk of tube shortages: A blood collection tube validation study conducted in South Africa.

BACKGROUND: The National Health Laboratory Service was using Becton Dickinson (BD) blood drawing tubes and, in 2021, the supplier notified customers of supply challenges, indicating a risk of global shortages. OBJECTIVE: This study aimed to validate candidate blood collection tubes from four brands (VACUCARE, VACUETTE(®), VACUTEST(®), and V-TUBE(™)) compared to BD Vacutainer(®) tubes in three National Health Laboratory Service laboratories in Cape Town, South Africa. METHODS: Blood was collected from 300 healthy volunteers between October 2021 and November 2021. The technical validation assessed 11 quality indicators, with a sigma metric greater than 4 deemed acceptable. Usability feedback was gathered from phlebotomists. The clinical validation estimated differences in results across 52 clinical chemistry tests, using desirable bias specified by the European Federation of Clinical Chemistry and Laboratory Medicine Biological Variation Database, or Ricos, as acceptance criteria. Analysis was performed on Roche cobas(®) 6000 and DiaSorin Liaison(®) XL analysers. RESULTS: All VACUCARE tubes exhibited sigma metrics above 4, indicating excellent performance. VACUETTE(®) and V-TUBE(™) were not uncapped by all Roche pre-analytical systems. VACUTEST(®) caps had rigid rubber, making it more challenging to puncture and detach the tube, which resulted in needle displacement. Both VACUCARE and V-TUBE(™) were reported as user-friendly. All candidate tube analytes showed acceptable clinical performance. CONCLUSION: VACUCARE, VACUETTE(®), VACUTEST(®) and V-TUBE(™) are viable alternatives to BD Vacutainer(®). However, based on the results obtained from the technical validation, VACUCARE was identified as the most suitable interim replacement for BD Vacutainer(®) during the shortage. WHAT THIS STUDY ADDS: This study addresses a gap in the literature on tube validation and provides valuable insights for clinical laboratories considering a replacement. It also presents an alternative approach to technical validation by utilising sigma metrics.