Performance Verification of a Separating Gel Procoagulant Vacutainer

Shao Yan; Sun Jing; Cheng Lei

doi:10.3969/j.issn.1004-5775.2025.07.018

Abstract：Objective:To validate the performance of a separating gel procoagulant vacutainer and evaluate its potential for clinical detection of tumor markers and thyroid hormone.Methods:According to the method of WS/T224-2018 document,the external appearance of the vacutainer,the amount of suction,the strength of the tube body,the hanging of fibrin,the hemolysis after centrifugation and the comparability of the results were verified.The comparability of the results was verified by taking the morning fasting venous blood of 20 hospitalized patients from the hospital from October 2021 and March 2022,and placing them in either vacutainer after serum isolation,10 tumor markers and 5 thyroid hormone were detected by chemiluminescent immunoassay,with no statistically significant difference(P＞0.05).Linear fitting was made making the detection value of the contrast tube as X-axis,and the detection value of the inspection tube as Y-axis.The bias at the level of medical decision was calculated,which need meet the minimum standard of analytical quality set by the national authorized institution.Results:The random Vacutainers were transparent in appearance,no foreign body,no deformation,no damage,no clear identification,no abnormal color and no falling off of the pipe cover,and the separated colloid in the pipe was gelatinous.The deviation between the actual suction volume and the theoretical value was between-4.64％and 7.41％,which was within±10％of the deviation range claimed by the manufacturer.There was no fibrin hanging on the wall,hemolysis or gel turnover in the tubes after centrifugation.There was no significant difference between the two vacutainers of tumor markers and Thyroid hormone except for TSH(P＞0.05).The relative bias at the medical decision level(lower limit of the reference interval,upper limit of the reference interval,2 times of the upper limit of the reference interval,5 times of the upper limit of the reference interval)was 1/2TEa,which was clinically acceptable.Conclusion:Clinical laboratories should evaluate the quality of blood collection vessels according to the requirements of the industry standard documents when selecting them.The quality of the selected vacutainer meets the industry requirements,and can be used for clinical detection of tumor markers and thyroid hormone.