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J Lab Med Qual Assur. 2009 Dec;31(2):301-308. Korean. Original Article.
Hwang SS , Yoon KR , Yoon KJ .
Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea. 41269@hanmail.net
Abstract

BACKGROUND: Recently, three collection tubes manufactured in China (Zhejiang Gongdong Medical Plastic Factory, Guangzhou Improve IVD) were introduced. We compared the performance of the three tubes with the existing BD Vacutainer tube (BD, USA) for common analytes. METHODS: Twenty healthy volunteers were recruited for this study. Routine chemistry, thyroid function test, and hematologic test were analyzed with these tubes, and compared the results by Student paired t-test and Bland-Altman Plot. For stability test, the initial results for each tube were compared with results of 72-hour preserved samples. RESULTS: For Gongdong tube, total bilirubin (T-BIL), glucose (GLU), phosphorus (PHOS), hemoglobin (Hb) and mean corpuscular volume (MCV) were lower, and total protein (TP), AST, direct bilirubin (D-BIL), unsaturated iron binding capacity (UIBC), total iron binding capacity (TIBC) and free thyroxine (FT4) were higher than those of BD tube. For Gongdong2 tube, ALT, T-BIL, PHOS, lactate dehydrogenase and MCV were lower, and D-BIL was higher than that of BD tube. For Improve tube, corpuscular hemoglobin concentration mean (CHCM) was lower, and albumin (Alb), blood urea nitrogen (BUN), creatinine (Cr) and FT4 were higher than those of BD tube. For three tubes, triiodothyronine (T3) was lower, and triglyceride (TG) and magnesium (Mg) were higher than those of BD tube (P<0.05). All statiscally different cases were clinically acceptable by CLIA'88 programs except D-BIL, UIBC, TIBC, Hb, MCV and CHCM those were not considered to be clinically significant. Most of stability tests showed variation within ten percents. CONCLUSIONS: The three tubes showed satisfactory results compared with existing BD Vacutainer tube. We concluded that the tubes are suitable for common laboratory tests.

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