Abstract Background Clinical laboratory tests require reliable vacuum blood collection tubes for accurate results. The importance of evaluating new blood collection devices is underscored by the potential effects they can have on various laboratory tests1. International guidelines recommend stringent and objective performance verification before introducing newly developed products into clinical use. We evaluated the performance of recently developed AMPULAB tubes (Soyagreentec, Hwasung, Korea) compared with established BD Vacutainer tubes (Becton Dickinson, Sunnyvale, CA) for routine clinical laboratory testing. Methods Blood samples were collected from 126 volunteers using both AMPULAB and BD tubes: ethylenediaminetetraacetic acid tubes (EDTA), serum separator tubes (SST), and sodium citrate tubes (SCT), n=80 each. 55 parameters were measured simultaneously on their designated automated analyzers: 21 hematology parameters with EDTA, 29 clinical chemistry parameters with SST, and 5 coagulation parameters with SCT. Statistical analysis was performed using Passing-Bablok regression and paired t-test. Clinical significance was assessed by comparing percent bias with minimum bias criteria from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) or Westgard biological variation database. Results The analysis of EDTA parameters indicated statistically significant differences in white blood cell count, mean corpuscular volume, and mean corpuscular hemoglobin concentration, all of which remained within the prescribed minimum bias ranges. The assessment of SST parameters revealed significant differences across 15 analytes, including triglycerides, high-density lipoprotein, calcium, uric acid, chloride, albumin, gamma-glutamyl transferase, direct bilirubin, creatinine, phosphorus, lactate dehydrogenase, glucose, iron, magnesium, and potassium; only glucose exceeded the specified minimum bias range. The evaluation of SCT parameters demonstrated significant differences in prothrombin time and fibrinogen, both of which maintained compliance with the minimum bias ranges. Conclusion The AMPULAB tubes exhibited performance comparable to BD Vacutainer tubes for most hematology, clinical chemistry and coagulation parameters, maintaining results within clinically allowable ranges.
Park et al. (Wed,) studied this question.