Comparison of Improvacuter EDTA Tube with BD Vacutainer EDTA Tube for Routine Hematological Analysis: Clinical Significance of Differences, Stability Study, and Effects of Kâ‚‚ and Kâ‚ƒ EDTA

Ahn, Sunyoung; Cho, Sun Mi; Shin, Hwachoon; Lee, Kyung A

Abstract

BACKGROUND
The type of blood collection tubes is an important pre-analytical factor that may affect test results. We compared the test results of the Improvacuter EDTA tube (Improve Medical, China) with those of the currently used BD Vacutainer EDTA tube (Becton Dickinson, USA) and investigated the effects of Kâ‚‚ and Kâ‚ƒ EDTA additives.
METHODS
Peripheral blood samples from 100 outpatients were collected into the aforementioned tubes. The samples were evaluated for 17 hematological analytes, hemoglobin A1c, and erythrocyte sedimentation rate (ESR). The results were analysed using the paired t-test for comparison. Bland-Altman plots and Passing-Bablok regressions were used for analytes with statistically significant differences in the comparison. If the differences were not within total allowable error, they were defined as clinically significant. For stability testing, the initial results were compared against those from samples preserved for 72 hours. White blood cell count, red blood cell count, platelet count, and mean corpuscular volume from both tubes were compared to ascertain the differences between Kâ‚‚ and Kâ‚ƒ EDTA additives.
RESULTS
Hematocrit, mean corpuscular volume, mean corpuscular haemoglobin concentration, and ESR showed statistically significant differences (P<0.05) between two tubes. However, these differences were not considered clinically significant. Most of the analytes presented statistically significant differences in stability test; however, they were not clinically significant either. Additionally, the differences in the hematological parameters shown in the outcome were not clinically significant, depending on the type of the EDTA additives.
CONCLUSIONS
The results indicate that Improvacuter EDTA tubes showed satisfactory performance. We conclude that the tubes are suitable for common clinical hematological use.