A-122 Evaluation of the Performance of the BD MiniDraw™ Capillary Blood Collection System Under Various Transport Conditions

Abstract

Abstract Background Specimen transport is a vital component of the preanalytical phase. External factors such as temperature fluctuations, vibrations, shock, and prolonged transport times may negatively impact specimen integrity and compromise test results. A study was performed to evaluate the effects of temperature extremes and simulated transportation on specimen quality in the BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H and SST™ Capillary Blood Collection Tubes (BD MiniDraw™ H&H, BD MiniDraw™ SST™). The BD MiniDraw™ Capillary Blood Collection System enables capillary blood collection by trained healthcare workers in non-traditional settings (i.e., retail pharmacies and clinics). Methods Sixteen adult participants were enrolled from the on-site Associate Sample Collection Program. Venous blood was collected via venipuncture into reference comparator and no-additive tubes. Venous blood from no-additive tubes was then pooled into a secondary container for aliquoting into BD MiniDraw™ SST™ and MiniDraw™ H&H tubes. Thirty tubes per tube type were separated into 6 groups with storage and simulated transport conditions conducted in accordance with ASTM D7386-16 and ASTM D4169-22, as applicable: Group 1a: No transport, 2-8°C storage uncontrolled humidity, 49-52-hour storage; Group 1b: Air/road transport, 2-8°C storage uncontrolled humidity, 49-52-hour storage; Group 2a: No transport, 20-24°C storage, uncontrolled humidity, 5-7-hour storage; Group 2b: Road transport, 20-24°C storage, uncontrolled humidity, 5-7-hour storage; Group 3a: Road transport, 38-40°C storage, 90% relative humidity, 5-7-hour storage; Group 3b: Air/road transport, 38-40°C storage, 90% relative humidity, 49-52-hour storage Following clotting, centrifugation, and storage for the BD MiniDraw™ SST™ tubes, testing was performed for selected chemistry analytes (Albumin, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALKP), Blood Urea Nitrogen, Chloride, Calcium, Cholesterol, Creatinine, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Sodium, Total Bilirubin (TBIL), Total Protein, Triglycerides) on the Siemens Atellica® Solution. Testing was performed for hemoglobin/hematocrit on the Sysmex XN-1000 in the BD MiniDraw™ H&H Tubes. Visual quality (barrier formation, hemolysis) and tube integrity (physical damage, blood leakage, cap removal, tube fit into adaptor) were also evaluated. Mean biases and confidence intervals within the specific analyte clinical acceptance limit for each group comparison was considered clinically equivalent. Results Clinical equivalence was demonstrated for all analytes for each group comparison except ALKP, ALT, HDL, LDL, TBIL and hematocrit for the extreme transport/storage conditions for Group 3b versus Group 3a. Complete barrier formation with acceptable visual hemolysis was noted in all specimens post transport. Tube integrity was maintained post transport as well. Conclusions Analytes were not impacted across a wide range of temperature and transport conditions. However, exposing samples to extreme high temperature, high humidity conditions may affect analyte performance. This reiterates the importance of monitoring conditions to ensure accurate test results. No impact to visual observations of sample quality and tube physical integrity was noted at different storage and transportation extremes.