A Comparison of the Performance of Soyagreentec Ampulab EDTA and Sodium Citrate Tubes with That of BD Vacutainer Tubes

ABSTRACT

BACKGROUND: Because blood collection tube can affect the results of various laboratory tests, it is necessary before using a newly developed product to verify its performance stringently and objectively. We compared the performance of Ampulab EDTA and sodium citrate tubes (Soyagreentec, Korea) with that of Vacutainer tubes (BD, USA) in accordance with international guidelines. METHODS: This study was performed as a multicenter study of Chung-Ang University Hospital and Seoul National University Hospital to evaluate the performance of two different instrument platforms. We performed the precision test according to CLSI GP34-A, the accuracy test according to CLSI EP09-A2-IR, and the vacuum test according to CLSI H1-A5 as well as stability, and aseptic condition tests. We evaluated 3 lots of Ampulab tubes for their precision, accuracy, vacuum, and aseptic condition. RESULTS: In precision test, the total precision levels of Ampulab tubes in most measurands were desirable or allowable. The results of mean corpuscular hemoglobin concentration, platelet distribution width, basophil, and reticulocyte counts for Ampulab tubes showed imprecision beyond allowable limits, but were similar to those of Vacutainer tubes. In the accuracy test, the bias in most measurands, except for the mean platelet volume, was within allowable limits. In the stability test, Ampulab showed similar performance to Vacutainer. In tests of the vacuum and aseptic conditions, Ampulab fulfilled both requirements. CONCLUSIONS: The performance of Ampulab EDTA and sodium citrate tubes was equivalent to that of Vacutainer tubes.