Performance evaluation of vacuum blood collection tubes in multicenter clinical laboratories: a real-world study from Southwest 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.