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Performance evaluation of vacuum blood collection tubes in multicenter clinical laboratories: a real-world study from
Changrui Sun1, Chunbao Xie1, Xuelong Xie2
1Department of Laboratory Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.
Background:
Pre-analytical errors account for 60-70% of total laboratory errors, with vacuum blood collection tube quality being a key contributor. Southwest China's complex terrain (plain/plateau areas) and demand for inter-hospital test result mutual recognition highlight the need for region-specific performance data.
Methods:
This multicenter real-world study evaluated 10 blood collection tube brands across 10 hospitals (plain/plateau areas) in Sichuan-Chongqing. Nine physical performance indicators (appearance, tube strength, fill volume, stopper shedding, hemolysis, fibrin adhesion, separation gel integrity, anticoagulation efficacy, and tube-body integrity) were verified against BD tubes, following CLSI GP34-A2 and WS/T 224-2018, with additional clinical consistency analyses for hematological, coagulation, and biochemical parameters. Statistical analysis included linear regression (R 2) and relative/comparison bias.
Results:
Widespread performance deficiencies were observed. At the hospital level, fill-volume non-compliance affected 78.3% (7/9) of plain-area hospitals, while at the tube-batch level, 20.0% (1/5) of batches failed at the single plateau site. For stopper shedding, 83.3% (25/30) of tube batches across all sites exceeded the acceptable threshold, corresponding to 80% (8/10) of hospitals having at least one non-compliant tube type. Tube appearance, structural strength, and separation gel integrity were universally compliant across all sites.
Conclusion:
Southwest China's routinely used vacuum blood collection tubes exhibit critical performance gaps, particularly in fill-volume accuracy and stopper integrity. Routine verification of high-risk indicators, site-adaptive batch-specific verification for high-altitude facilities, and manufacturing improvements (e.g., stopper material optimization) are recommended. This study provides quality benchmarks for regional test result mutual recognition and pre-analytical quality improvement.
