Evaluation of analytical equivalence between Ampulab and BD Vacutainer blood collection tubes across clinical chemistry, immunoassay, hematology, and coagulation panels

Blood collection tubes significantly impact laboratory test accuracy, yet supply chain vulnerabilities of imported tubes necessitate evaluating domestic alternatives. This study compared the analytical performance of Ampulab and BD Vacutainer tubes. Paired blood samples were collected from 44 adult volunteers into Ampulab and BD Vacutainer tubes. Sixty-five analytes across clinical chemistry, immunology, hematology, and coagulation panels were analyzed using established platforms. Statistical comparisons included Passing-Bablok regression, Bland-Altman analysis, Wilcoxon signed-rank tests, and bias estimation against desirable biological variation thresholds. Most analytes showed acceptable agreement between the two tube types. Lactate dehydrogenase showed greater variability, exceeding the desirable bias (-4.37% vs. 3.1%), whereas chloride demonstrated a marginal deviation (-0.43% vs. 0.4%) with absolute differences remaining within 1-2 mmol/L. Prostate-specific antigen exhibited a bias above the desirable threshold at low concentrations but showed good regression agreement overall. Several hematology parameters, including white blood cells, mean corpuscular volume, and neutrophils, showed statistically significant differences; however, all remained within acceptable bias limits. Coagulation analytes demonstrated strong analytical agreement, but fibrin degradation product (FDP) showed greater variability without established performance criteria, indicating a need for further validation. Ampulab tubes demonstrated analytical performance comparable to BD Vacutainer tubes for most parameters tested. Serum separator and EDTA tubes are suitable for routine clinical use. Sodium citrate tubes require further validation for fibrinogen and FDP. These findings support the implementation of Ampulab tubes in clinical laboratories, with targeted verification recommended for selected analytes.