Objective To evaluate the quality of vacuum blood collection tube by testing three key properties of EDTAK2 vac-uum blood collection tube including nominal liquid capacity,leakage and the actual amount of additives.Methods A total of 27 batches samples were collected,which distributed in 10 production enterprises in 6 provinces,including 4 batches in Shandong(14.8％),1 batch in Hebei(3.7％),1 batch in Guangdong(3.7％),1 batch in Hubei(3.7％),18 batches in Hunan(66.7％),and 2 batches in Guizhou(7.4％).According to standard YY/T 0314-2007 of Disposable human venous blood sample collection container,27 batches of vacuum tube were tested for nominal liquid capacity,leakage and actual amount of additives.Results The qualified rate of nominal liquid capacity was 85.2％,leakage was 100％,and the actual amount of additive was 60％.Compared the product technical requirements with industry standards,it was found that flaws existed in some product technical inspection methods or the methods were non-operatable,even were wrong,unreasonable and unscientif-ic.There was no specific additive type,altitude requirement and other issues on product label.The main reasons for un-qualifi-cation were unstable vacuum process in production of blood collection tubes,inaccurate preparation and the filling amount of additives,lax quality control,imprecise product technical requirements and imperfect document review mechanism.Conclusion It is demonstrated that some manufacturers have quality problems in vacuum blood collection tubes,all relevant departments should attach great importance to quality control and improve the overall quality.
ethylenediaminetetraacetic acid dipotassium salt dihydrate(EDTAK2)anticoagulant vacuum blood collection tubenominal liquid capacityleakageactual amount of additives
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