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1 임상검사와정도관리 : 제 31 권제 2 호 2009 J Lab Med Qual Assur 2009; 31: 종의진단검사를대상으로세종류의플라스틱진공채혈관 (Gongdong 사의 Vacuum Blood Tube 두종류및 Improve 사의 Vacuum Blood Collection Tube) 과 BD Vacutainer Tube 의비교 황상선 윤광로 윤갑준 연세대학교원주의과대학진단검사의학교실 Comparison of Three Plastic Tubes (Two Gongdong Vacuum Blood Tubes and Improve Vacuum Blood Collection Tube) with BD Vacutainer Tube for 37 Laboratory Tests Sang Sun Hwang, Kwang Ro Yoon, and Kap Jun Yoon Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea 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. Key Words:Collection tube, BD Vacutainer tube, Zhejiang Gongdong, Guangzhou Improve 교신저자 : 황상선우 ) 강원도원주시일산동 162 원주기독교병원진단검사의학과전화 :033) , 팩스 :033) @hanmail.net 서론진단검사의학과에서시행하는대부분의검사는혈액검체를이용하고있으며, 혈액을채취하는과정은검사결과를

2 302 황상선 윤광로 윤갑준 변화시킬수있는검사전요인중하나이다. 분석기술의발달로검사변수가줄어서이런검사전변수가상대적으로중요해지고있기에채혈관은정확한검사의기본조건이다 [1,2]. 채혈관은 Becton Dickinson (BD, Franklin Lakes, NJ, USA) 사에서최초로진공채혈관을개발하여널리사용되고있으며, 초기에는유리로만든채혈관이사용되었으나최근에는대부분플라스틱으로만든진공채혈관이사용되고있다 [3-8]. 진공채혈관은다양한첨가물을포함하여혈액응고를방지하거나촉진하는등의기능이있고, 첨가물의종류에따라마개의색상에따라채혈자들이쉽게구분할수있도록고안되었다 [2]. 현재국내에서는 BD 사의 Vacutainer 진공채혈관과 Greiner 사의 Vacuette 진공채혈관 (Greiner Bio-One GmbH, Frickenhausen, Germany) 이흔히사용되고있으며, 최근에일본의 Sekisui 사의 INSEPACK 진공채혈관 (Sekisui Chemical Co., Osaka, Japan) 과녹십자사에서개발한 Green Vac-Tube (Green Cross MS Corp., Yongin, Korea), SPM 사의진공채혈관 (SPM, Gimje, Korea) 등이소개되어각자검증된바가있다 [2,4]. 본연구자들은최근소개된 Gongdong 사 (Zhejiang Gongdong Medical Plastic Factory, Zhejiang, China), 의 Gongdong Gongdong2 등 2종류의진공채혈관과 Guangzhou Improve IVD사진공채혈관 (Guangzhou Improve IVD, Guangdong, China) 을이용한측정값을기존에사용하고있던 BD Vacutainer 진공채혈관을이용한측정값과비교분석하였고, 또한검체를냉장보관후각검사의안정성을조사하여 Gongdong, Improve 사의진공채혈관이임상적으로사용하기에적절한지검증해보고자하였다. 대상및방법 1. 대상총 20명의건강한지원자를대상으로하였으며, 모두 18 세이상의성인들로서남자와여자가각각 14명, 6명이었다. 모든지원자에게연구에대한서면동의를받았으며모든시행과정은원내임상시험심사위원회 (IRB) 의승인을받았다. 2. 방법 1) 진공채혈관평가하는진공채혈관은 Vacutainer (BD), Gongdong 사의 Gongdong, Gongdong2 등 2가지제품, Improve (Improve) 등세회사의 4가지제품이었다. 진공채혈관은첨가물에따라각각 serum separator tube (SST), ethylenediaminetetraaceticacid (EDTA) 2종류를사용하였으며, 한명의지원자당총 8개의진공채혈관에채혈을실시하였다. Gongdong tube (Disposable Vacuum Blood Collection Tube-GD050SGC, EDTA K2/K3 blood collection tube-gd030ek) 의경우 SST 의내부겔, EDTA tube 의항응고물질등을 BD 사에서수입하여제조한것이고, Gongdong2 tube 는이런겔이나항응고물질등을자체적으로만든것이다. 모든검사에서기존에사용하던 BD Vacutainer 플라스틱진공채혈관을대조군으로사용하였다. 2) 평가검사항목과분석장비 SST 진공채혈관으로는일반화학검사중 total protein (TP), albumin (Alb), total cholesterol (CHOL), triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL), AST, ALT, alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), total bilirubin (T-BIL), direct bilirubin (D-BIL), glucose (GLU), blood urea nitrogen (BUN), creatinine (Cr), calcium (Ca), phosphorus (PHOS), magnesium (Mg), creatine kinase (CK), lactate dehydrogenase (LD), uric acid (UA), ferrous iron (FE), unsaturated iron binding capacity (UIBC), total iron binding capacity (TIBC), C-reactive protein (CRP) 등의총 25 가지항목을 Modular DPE (Hitachi Hitechnologies, Tokyo, Japan) 을이용하여시행하였고갑상선기능검사중 triiodothyronine (T3), free thyroxine (FT4), thyroid stimulating hormone (TSH) 등 3 가지항목을 Advia Centaur (Siemens, Tarrytown, NY, USA) 을이용하여시행하였다. EDTA 진공채혈관으로는백혈구수 (WBC), 적혈구수 (RBC), hemoglobin (Hb), hemoglobin distribution width (HDW), mean corpuscular volume (MCV), corpuscular hemoglobin concentration mean (CHCM), red cell distribution width (RDW), platelet (PLT), mean platelet volume (MPV) 등 9항목을자동혈액분석기인 Advia 2120 (Siemens) 을이용하여시행하였다. 3) 채혈및검사전처리지원자들은 12시간이상금식한후아침에 SST 로각각 5 ml, EDTA tube 로각각 3 ml 씩총 32 ml 의혈액을정맥천자로채혈하였다. 채혈방법은본원의혈액검사채혈지침에따랐다. 모든검체는 BD 사의 needle 을사용하여채취하였으며, 채혈후혈청분리용진공채혈관은실온에 30

3 세종류의플라스틱진공채혈관과 BD Vacutainer Tube 의비교 303 Table 1. Statiscal analysis of the measured results in samples from collection tubes (mean±sd, N=20) Tests (unit) BD Improve Gongdong Gongdong2 TP (g/dl) 7.71 ± ± ± ± 0.43 ** ALB (g/dl) ± ± * ± ± CHOL (mg/dl) ± ± ± ± 35.3 ** TG (mg/dl) ± ± * ± ± LDL (mg/dl) ± ± ± ± 27.4 HDL (mg/dl) 61.2 ± ± ± ± 14.5 AST (U/L) C* 18.7 ± ± ± 3.9 * 18.5 ± 4.2 ALT (U/L) 21.1 ± ± ± ± 9.3 ALP (U/L) 60.7 ± ± ± ± 14.5 GGT (U/L) 46.8 ± ± ± ± 42.8 T-BIL (mg/dl) ± ± ± ± D-BIL (mg/dl) ± ± ± ± 0.04 * GLU (mg/dl) 89.1 ± ± ± ± 11.0 BUN (mg/dl) ± ± 4.08 * ± ± 3.97 Cr (mg/dl) ± ± * ± ± CA (mg/dl) 9.77 ± ± ± ± 0.32 PHOS (mg/dl) 3.78 ± ± ± 0.57 * 3.74 ± 0.59 * MG (mg/dl) 2.36 ± ± 0.14 * 2.41 ± ± 0.13 *** CK (mg/dl) ± ± ± ± LD (IU/L) ± ± ± ± 23.3 UA (mg/dl) 5.64 ± ± ± ± 1.43 FE (μg/dl) ± ± ± ± 29.0 ** UIBC (μg/dl) ± ± ± 49.5 * ± 49.8 TIBC (μg/dl) ± ± ± 35.4 * ± 35.5 CRP (mg/dl) ± ± ± ± T3 (ng/ml) ± ± * ± * ± FT4 (ng/ml) ± ± ± ± TSH (U/mL) ± ± Omitted ± WBC (x10 9 /L) ± ± ± ± RBC (x10 12 /L) ± ± ± ± Hb (g/dl) ± ± 1.52 * ± ± 1.50 HDW (g/dl) ± ± ± ± MCV (fl) ± ± ± ± 3.82 CHCM (g/dl) ± ± 1.30 * ± ± 1.31 RDW (%) ± ± ± ± 2.57 PLT (x10 9 /L) ± ± ± ± 63.5 MPV (fl) 8.44 ± ± ± ± 0.63 P values were calculated by Student paired t-test. * P<0.05, P<0.01, P<0.001 compared with BD; P<0.05, P<0.01, P<0.001 compared with Improve; ** P<0.05, P<0.01, P<0.001 compared with Gondong1. Abbreviations: TP, total protein; ALB, albumin; CHOL, total cholesterol; TG, triglyceride; LDL, low density lipoprotein; HDL, high density lipoprotein; ALP, alkaline phosphatase; GGT, gamma-glutamyltransferase; T-BIL, total bilirubin; D-BIL, direct bilirubin; GLU, glucose; BUN, blood urea nitrogen; Cr, Creatinine; CA, calcium; PHOS, phosphorus; MG, magnesium; CK, creatine kinase; LD, lactate dehydrogenase; UA, uric acid; FE, ferrous iron; UIBC, unsaturated iron binding capacity; TIBC, total iron binding capacity; CRP, C-reactive protein; T3, triiodothyronine; FT4, free thyroxine; TSH, thyroid stimulating hormone; WBC, white blood cell; RBC, red blood cell; Hb, hemoglobin; HDW, hemoglobin distribution width; MCV, mean corpuscular volume; CHCM, corpuscular hemoglobin concentration mean; RDW, red cell distribution width; PLT, platelet; MPV, mean platelet volume.

4 304 황상선 윤광로 윤갑준 Table 2. Comparison of results on day 0 and day 3 (%change compared with day 0, N=20) %change BD Improve Gongdong Gongdong2 TP (g/dl) ALB (g/dl) CHOL (mg/dl) TG (mg/dl) LDL (mg/dl) HDL (mg/dl) AST (U/L) ALT (U/L) ALP (U/L) GGT (U/L) T-BIL (mg/dl) D-BIL (mg/dl) GLU (mg/dl) BUN (mg/dl) Cr (mg/dl) CA (mg/dl) PHOS (mg/dl) MG (mg/dl) CK (mg/dl) LD (IU/L) UA (mg/dl) FE (μg/dl) UIBC (μg/dl) TIBC (μg/dl) CRP (mg/dl) T3 (ng/ml) Omitted -8.9 FT4 (ng/ml) Omitted -8.4 TSH (U/mL) Omitted -3.7 WBC (x109/l) RBC (x1012/l) Hb (g/dl) HDW (g/dl) MCV (fl) CHCM (g/dl) RDW (%) PLT (x109/l) MPV (fl) Abbreviations: See Table 1.

5 세종류의플라스틱진공채혈관과 BD Vacutainer Tube 의비교 305 Fig. 1. Bland-Altman plot of statistically significant results for CBC, routine chemistry and thyroid function test in samples collected from BD Vacutainer tube and other three plastic collection tubes. Abbreviations: I, Improve tube; G1, Gongdong tube; G2, Gongdong2 tube; See Table 1.

6 306 황상선 윤광로 윤갑준 Fig. 1. Continued.

7 세종류의플라스틱진공채혈관과 BD Vacutainer Tube 의비교 307 분동안두었다가 2,000 rpm 으로 10분동안원심분리하였다. 검사후에는검체를 3일간 4 에냉장보관하였다가다시같은종목을검사하여각진공채혈관의안정성을평가하였다. 4) 통계각플라스틱진공채혈관의채혈후두시간이내 (t=0 hr) 의검사결과와 BD 진공채혈관결과를 Student paired t-test 를이용하여비교분석하였고통계적으로유의한차이가발생했을경우 (P<0.05) 에 Bland-Altman plot 을이용하여분석된결과값의차이가평균의 2SD 한계치인 95% 내에들지않는경우를분석해보았다 [9]. 통계분석은 Analyse-It Software version 2.12 (Analyse-It Software, Leeds, England) 를이용하였다. 결과 Student paired t-test 로분석한결과여러검사에서통계학적으로의미있는차이가발생하였다 (P<0.05). BD 사의 tube 와비교시 Gongdong tube 는일반화학검사의 TP, TG, AST, T-BIL, D-BIL, GLU, PHOS, Mg, UIBC, TIBC 등의 10가지항목에서, 갑상선기능검사의 T3, FT4 등 2가지항목에서, 일반혈액검사의 MCV 1가지항목에서유의한차이가있었다. Gongdong2 tube 는일반화학검사의 TG, ALT, T-BIL, D-BIL, PHOS, Mg, LDH 등의 7가지항목에서, 갑상선기능검사의 T3 1가지항목에서, 일반혈액검사의 MCV 1가지항목에서유의한차이가있었다. 또한 Improve 사의 tube 의경우일반화학검사의 Alb, TG, BUN, Cr, Mg 등 5가지항목에서, 갑상선기능검사의 T3, FT4 등 2가지항목에서, 일반혈액검사의 MCV, CHCM 등 2가지항목에서유의한차이가있었다 (Table 1). 안정성의경우에는대부분의항목에서채혈 3일후 10% 이내의변이를보였다 (Table 2). 고찰초기의플라스틱채혈관은혈액성분일부가채혈관내벽에흡착되어측정치가실제보다낮게나오는등의단점이있어기존의유리채혈관을대체하기힘들었다 [10]. 이후이런단점을보완하고성능검증을통해, 지금은대부분의병원에서검사실자동화에적합한플라스틱진공채혈관이사용되고있다 [5-8]. 지난 20년간채혈관에서의가장두드러진두가지변화는 SST 에서혈청과세포성분사이의장벽역할을하는겔을포함시킨것과재질이유리에서플라스틱으로대체된것이고, 이로인해원심분리시간이줄고, 검체의안정성증가, 파손위험감소, 무게감소, 소각처리에적합한등여러이득을얻을수있었다 [11]. 일반혈액검사에서기존에보고된문헌에서는 RBC 와 MCV 가유의한차이가있다는보고가있었으나 [2,4] 본실험에서는 RBC 는차이를보이지않았고, MCV 만유의한차이가있었다. 통계학적으로유의한차이가관찰된 20여가지검사항목에대하여 Bland-Altman plot 을이용하여분석한결과진공채혈관의종류에따른검사결과의차이가표준편차의 1.96 배이상으로증가한검체가 1건관찰된것은 TP, Alb, TG, AST, D-BIL, GLU, PHOS, LDH, UIBC, TIBC, T3, FT4, Hb, MCV 등이었고, 2건관찰된것은 ALT, T-BIL, BUN, Cr, CHCM 등이었다 (Fig. 1). 많은검사 (Alb, TG, AST, ALT, T-BIL, GLU, BUN, Cr, PHOS, Mg, LDH, T3, FT4) 들이통계적으로유의한차이가있었지만, CLIA 88 에서제시한허용범위내에들었고, D-BIL, UIBC, TIBC, Hb, MCV, CHCM 의경우허용한계가명시된문헌이없었으나각각 (0.013 mg/dl, 2.6 μg/dl, 4.0 μg/dl, 0.12 g/dl, 1.62 fl, 0.83 g/dl) 이내의진공채혈관간변이를보여임상적인의미가미미한정도라고판단되었다 [4]. 검체의냉장보관에따른안정성검사에서는일반화학검사와갑상선기능검사에서 Gongdong tube 의 CK, Gongdong2 tube의 CRP, Improve tube의 T3 결과를제외한대부분의종목이채혈 3일까지 10% 이내의안정성을보여주었다. 문헌에서는 ALT 의경우채혈 1일에, AST, T3, TSH 의경우채혈 3일에 10% 가넘는변이를보였다고하였지만본실험에서는 AST, ALT 와 TSH 의경우안정성을보여주었다 [4]. 또한채혈 3일째에 10% 를벗어난 CK, T3의경우각각 CLIA 88 에서제시한 ±30%, ±3SD 이내의값을가지고있었고 CRP 의경우허용한계가명시된문헌이없었지만측정값이작아변화가크게느껴질뿐임상적인의의는없을것으로생각된다 [4]. 일반혈액검사의경우모든진공채혈관에서 10% 이내의안정성을보여주었다. 결론적으로, Gongdong, Improve 사의제품은기존의 BD 진공채혈관과비교했을때검사결과나안정성등에큰차이가없고, 경제적으로도장점이있으며검사자의만족도도좋았으므로향후검사실과병원운영면에도움을줄수있다고생각한다 [2]. 요약배경 : 최근중국의 Zhejiang Gongdong Medical Plastic Factory 사와 Guangzhou Improve IVD 사에서제조한세종류의진공채혈관이소개되었다. 이에기존의 BD Vacutainer tube (BD, USA) 와세진공채혈관으로채혈한검체로임상검사를시행하고측정값을비교분석하였다. 방법 : 20명의건강한지원자를모집하였다. 일반화학검

8 308 황상선 윤광로 윤갑준 사, 갑상선기능검사, 혈액검사를네종류의진공채혈관으로수행하였고, 검사결과는 Student paired t-test 와 Bland-Altman Plot 을이용하여비교하였다. 각 tube 의안정성을비교하기위하여검체를냉장보관하여 72시간후에다시검사하였다. 결과 : BD사의 tube에비해 Gongdong tube는총빌리루빈, 포도당, 인산염, 혈색소, 평균적혈구용적에서유의하게낮았고, 총단백질, 아스파라긴산아미노전이효소, 직접빌리루빈, 불포화철결합능, 총철결합능, 유리티록신에서는유의하게높았다. Gongdong2 tube 는알라닌아미노전이효소, 총빌리루빈, 인산염, 유산탈수소효소, 평균적혈구용적에서유의하게낮았고, 직접빌리루빈에서유의하게높았다. Improve 사의 tube 는평균적혈구혈색소농도에서는유의하게낮았고, 알부민, 혈중요소질소, 크레아티닌, 유리티록신에서유의하게높았다. 두회사의 tube 모두 BD tube 보다삼요오드티로닌에서는유의하게낮았으며트리글리세리드, 마그네슘의경우유의하게높았다. 통계적으로의미있는차이가발생한 (P<0.05) 많은검사중직접빌리루빈, 불포화철결합능, 총철결합능, 혈색소, 평균적혈구용적, 평균적혈구혈색소농도를제외하고 CLIA 88 에서제시한허용범위내에들었고, 제외된항목의경우임상적인의미가미미한정도라고판단되었다. 안정성의경우대부분의항목에서 10% 이내의변이를보였다. 결론 : 세종류의 tube 들은여러검사들에대해서기존의 BD Vacutainer Tube 와비교했을때만족스러운결과를보여서일상적인임상검사에적합하다고생각된다. 참고문헌 1. Zhang DJ, Elswick RK, Miller WG, Bailey JL. Effect of serum-clot contact time on clinical chemistry laboratory results. Clin Chem 1998;44: Kim JY, Nam DH, Kim SH, Yang JH, Yoon SY, Lim CS, et al. Evaluation of Green Vac-Tube in clinical laboratory tests. J Lab Med Qual Assur 2008;30: ( 김지용, 남덕화, 김선형, 양진혁, 윤수영, 임채승등. 임상검사에서 SPM Green Vac-Tube 진공채혈관의유용성평가. 임상검 사와정도관리 2008;30: ) 3. Henry JB and Kurec AS. The clinical laboratory: organization, purposes, and practice. In: Henry JB, ed. Clinical diagnosis and management by laboratory methods. 20th ed. Philadelphia: WB Saunders, 2001: Oh S-H and Ki C-S. Comparison of two new plastic tubes (Sekisui INSEPACK and Green Cross Green Vac-Tube) with BD Vacutainer tubes for 49 analytes. Korean J Lab Med 2007;27: ( 오수현및기창석. 49종의검사에대한새로운두종류의플라스틱진공채혈관 (Sekisui INSEPACK 및녹십자 Green Vac-Tube) 과 BD Vacutainer 진공채혈관의비교. 대한진단검사의학회지 2007;27:69-75.) 5. Hill B, Laessig RH, Koch DD, Hassemer DJ. Comparison of plastic vs. glass evacuated serum-separator (SST) blood-drawing tubes for common clinical chemistry determinations. Clin Chem 1992;38: Reinartz JJ, Ramey ML, Fowler MC, Killeen AA. Plastic vs glass SST evacuated serum-separator blood-drawing tubes for endocrinologic analytes. Clin Chem 1993;39: Preissner CM, Reilly WM, Cyr RC, O Kane DJ, Singh RJ, Grebe SKG. Plastic versus glass tubes: Effects on analytical performance of selected serum and plasma hormone assays. Clin Chem 2004;50: Kratz A, Stanganelli N, Van Cott EM. A comparison of glass and plastic blood collection tubes for routine and specialized coagulation assays: a comprehensive study. Arch Pathol Lab Med 2006;130: Dewitte K, Fierens C, Stöckl D, Thienpont LM. Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. Clin Chem 2002;48: ; author reply Holmquist L. Loss of human serum apolipoproteins C and E during manipulation of diluted solutions. J Lipid Res 1982;23: Bowen RA, Chan Y, Cohen J, Rehak NN, Hortin GL, Csako G, et al. Effect of blood collection tubes on total triiodothyronine and other laboratory assays. Clin Chem 2005;51:

원저 Lab Med Online Vol. 9, No. 2: 77-83, April 기타진단검사의학 임상검사실사용을위한메디온진공채혈관과 BD 진공채혈관의비교 Comparison between

원저 Lab Med Online Vol. 9, No. 2: 77-83, April 2019 기타진단검사의학 임상검사실사용을위한메디온진공채혈관과 BD 진공채혈관의비교 Comparison between Medion Tube and Tube for Clinical Laboratory Practice 장진호 조주영 이종한 김주원 Jinho Jhang, M.D., Ju