Applied research on micro blood collection tubes in clinical coagulation testing

Background: Vacuum blood collection tubes are essential for clinical testing, but traditional tubes have a number of limitations. Microtubes are increasingly being used to reduce required blood volumes and patient discomfort. Further research needs to be conducted on the efficacy of low-volume blood collection tubes in clinical laboratories. This study aimed to analyze the consistency of coagulation test results obtained using Gongdong and Kangjian microtubes. Methods: In total, 50 randomly selected patients underwent coagulation tests at our hospital using Yangpu coagulation tubes, Kangjian microtubes, and Gongdong microtubes. A CX-9000 blood coagulation analyzer was employed to determine the activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen (FIB) level, D-dimer level, fibrinogen degradation product (FDP) level, and antithrombin III (AT-III) level. Additionally, linear fitting was performed with the control tube results as “X” and the inspection tube results as “Y”. The expected bias (Bx) was then calculated using the following formula: Bx = a + (b – 1) / Xc, where Xc represents the medical level. Finally, the consistency between the results from the Yangpu coagulation tubes and microtubes, as well as the consistency between the results from the Gongdong and Kangjian microtubes, was assessed using 1/2 Clinical Laboratory Improvement Amendments (CLIA)’88 as the criterion. Results: No statistically significant differences were observed between the Yangpu tubes and both types of microtubes (P>0.05). Moreover, a strong correlation was found between the coagulation test results for the Yangpu coagulation blood tubes and those for the microtubes (P<0.05). In addition, the APTT, PT, TT, FIB, D-dimer, FDP, and AT-III results between the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. Conclusions: While this study demonstrates strong analytical agreement between conventional tubes and microtubes, further clinical studies are warranted to validate these findings in diverse patient cohorts and to assess the impact of tube substitution on clinical outcomes.