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 Young Cho, M.D., Jong-Han Lee, M.D., Juwon Kim, M.D. 연세원주의과대학진단검사의학과 Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea Background: Most of the blood-test samples are collected and carried in vacuum tubes. We have compared a newly developed vacuum tube, (Medion, Korea) and (BD, USA) in three common clinical assays, i.e., hematological, chemical, and immunological tests. Methods: A sum of 60 healthy volunteers were recruited in our study and their peripheral blood samples were collected in the tubes of the two brands. EDTA-tube samples were evaluated using 25 hematological tests. Serum separating tube samples were analyzed for 24 chemical parameters and the 3 thyroid hormones. The results were statistically analyzed using the paired t-test and Bland-Altman plot. In addition, the assay outcomes at t =0 hr were compared with those at t =24±2 hr for each of the tubes. Results: The assay results of 22 hematological parameters, 24 chemical parameters, and 3 thyroid hormones had a statistically significant correlation between the 2 brands of vacuum tubes (t =0 hr). Two hematological parameters (mean corpuscular hemoglobin concentration [ MCHC] and cell hemoglobin concentration mean [ CHCM]) showed higher mean values, while a hematological parameter (lobularity index [ LI]) showed lower mean values in than (t =0 hr). The results after 24 hr showed similarity between the 2 brands, with some inconsistent results in (Mean platelet volume [ MPV], plateletcrit [ Pct], eosinophil, calcium, and triiodothyronine) and (MPV, hemoglobin distribution width [ HDW], CHCM, Pct, eosinophil, and calcium). Conclusions: and tube showed good statistical concordance rate with some exceptions in the hematological parameters (MCHC, CHCM, and LI). Key Words: Comparison, Vacuum tube, Concordance, Parameters Corresponding author: Juwon Kim, M.D., Ph.D. https://orcid.org/0000-0003-2010-4491 Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju 26426, Korea Tel: +82-33-741-1593, Fax: +82-33-731-0506, E-mail: juwon76@yonsei.ac.kr Co-corresponding author: Jong-Han Lee, M.D., Ph.D. https://orcid.org/0000-0003-4036-8443 Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju 26426, Korea Tel: +82-33-741-1594, Fax: +82-33-731-0506, E-mail: cello425@yonsei.ac.kr Received: March 7, 2018 Revision received: August 7, 2018 Accepted: October 30, 2018 This article is available from http://www.labmedonline.org 2019, Laboratory Medicine Online This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 서론 진단검사의학과에서시행되는많은혈액검사는말초혈액을채혈하여이루어지고있다. 검사전단계에서일어날수있는오류의유형중혈액을채취하고보관하는과정에서사용하는채혈관의성능에따라오류발생률이크게영향을받을수있기에채혈관의성능이중요하다고할수있다 [1, 2]. 진공채혈관은 Becton Dickinson (BD, Franklin Lakes, NJ, USA) 사에서최초로개발하여사용되고있는 제품및기타많은채혈관제조회사의제품이이용되고있다. 현재유통되는채혈관의대부분은수입제품이차지하고있는데, 이를국내자체개발제품으로대체하려는노력이이어지고있다 [3]. 최근국내기업에서자체개발에성공한채혈관인 (Medion, Hwaseong, Korea) 이소개되어, 이번연구에서그기능을평가하고자하였다. 은기존의다른플라 eissn 2093-6338 www.labmedonline.org 77
스틱채혈관과마찬가지로기벽은 polyethylene terephthalate (PET) 로, 마개 (cap) 는 butyl rubber로이루어져있으며, EDTA tube 의첨가제로는 K 2 EDTA, K 3 EDTA를, gel tube의경우에는 n-butylacrylate ethylhexyl acrylate copolymer 의성분을사용하였다. 이번연구에서는임상검사에서흔히실시되는일반혈액검사, 일반화학검사및갑상선기능검사를포함한 52가지의검사종목들에대해기존의 Becton Dickinson사의 진공채혈관과비교하여, 새로개발된 Medion사의 진공채혈관의성능을비교및분석하고, 임상적으로적용하기에적절한지에대해검증해보았으며, 추가적으로실온및냉장보관후에각검사의안정성또한평가하였다. 재료및방법 1. 대상 연구에참여하기로동의한 60명을대상으로하였으며이는자발적으로참여한건강한 33명의남성지원자와 27명의여성지원자가포함되었고, 모든연구과정은원주세브란스기독병원연구심의위원회의승인 ( 승인번호 : 2017-04-0345) 을받아지원자들에게연구에대한서면동의를받았다. 2. 방법 1) 검체채취및보관새로개발된 Medion사및 BD사의진공채혈관의비교는 EDTA tube (K3 EDTA) 와 Serum separating tube (SST) 를대상으로하였다. 모든대상자에대하여채혈시에한종류의채혈홀더 (Becton Dickinson) 를사용하여채취하였다. 채혈후 2시간이내 (t = 0 hr) 검사시에는원심분리후마개를닫아실온에보관한검체를이용하였고, 채혈후 1일 (t =24±2 hr) 보관후검사시에는파라핀필름으로밀봉한채혈관을그대로 5 C 냉장보관하였다. 추가적으로일간안정성평가를위하여각채혈관에채혈후 1일동안냉장보관했을때각각검사결과의차이를평가하였다. 2) 검사항목과분석장비 EDTA 진공채혈관의검체로는 white blood cell (WBC, 10 3 /μl), red blood cell (RBC, 10 6 /μl), hemoglobin (Hb, g/dl), hematocrit (Hct, %), mean corpuscular volume (MCV, fl), mean corpuscular hemoglobin (MCH, pg), mean corpuscular hemoglobin concentration (MCHC, g/dl), red cell distribution width (RDW, %), hemoglobin distribution width (HDW, %), cell hemoglobin concentration mean (CHCM, g/dl), cellular hemoglobin (CH, pg), cell hemoglobin distribution width (CHDW, %), platelet (PLT, 10 3 /μl), mean platelet volume (MPV, fl), platelet distribution width (PDW, fl), plateletcrit (Pct, %), neutrophil (Neutro, %), lymphocyte (Lympho, %), monocytes (Mono, %), eosinophil (Eos, %), basophils (Baso, %), large unstained cells (LUC, %), nucleated red blood cells (nrbc/ 100 WBC), lobularity index (LI), mean peroxidase activity index (MPXI) 등 25종항목을 ADVIA 2120i (SIEMENS, Berlin, Germany) 로분석하였다. SST 진공채혈관의검체에대해서는일반화학검사중 C-reactive protein (CRP, mg/dl), aspartate aminotransferase (AST, U/L), alanine aminotransferase (ALT, U/L), alkaline phosphatase (ALP, U/L), gamma-glutamyltransferase (GGT, U/L), total bilirubin (T-Bil, mg/dl), direct bilirubin (D-Bil, mg/dl), calcium (Ca, mg/dl), magnesium (Mg, mg/dl), phosphorus (P, mg/dl), ferrous iron (Fe, µg/dl), unsaturated iron binding capacity (UIBC, µg/dl), total protein (TP, g/dl), albumin (Alb, g/dl), glucose (Glu, mg/dl), uric acid (UA, mg/dl), lactate dehydrogenase (LDH, U/L), creatine kinase (CK, U/L), blood urea nitrogen (BUN, mg/dl), creatinine (Cre, mg/ml), total cholesterol (T. Chol, mg/dl), triglyceride (TG, mg/dl), high density lipoprotein (HDL, mg/dl), low density lipoprotein (LDL, mg/dl) 등의총 24가지항목을 Cobas 8000 (Roche, Basel, Switzerland) 생화학장비및전용시약으로, 갑상선기능검사중 triiodothyronine (T3, ng/ml), free thyroxine (FT4, ng/dl), thyroid stimulating hormone (TSH, μiu/ml) 등 3가지항목을 ADVIA Centaur XPT (SIEMENS, Berlin, Germany) 장비및전용시약을이용하여검사하였다. 3) 통계분석 와 의진공채혈관간채혈후 2시간이내 (t = 0 hr) 의검사결과의차이는 Paired t-test로비교분석하였다. 일반혈액검사, 일반화학검사와갑상선기능검사의평가는채혈후 2 시간이내 (t = 0 hr) 와 1일 (t =24±2 hr) 에분석하여그차이를비교하였다. 통계적으로유의한차이가발생했을경우 (P<0.05) 에 Bland- Altman plot을이용하여분석된결과값의차이가표준편차의 1.96 배이상으로증가한검체를분석하였다 [5]. 통계분석은 SPSS 소프트웨어패키지 (Version 23.0. SPSS Inc., Chicago, IL, USA) 와 Microsoft Excel (Microsoft, Redmond, WA, USA) 을이용하여분석하였다. P값이 0.05 미만일때통계적으로의미있는것으로판단하였다. 결과 1. EDTA tube 와 의 EDTA tube를이용하여시행한일반혈액검사 25종의항목에대하여채혈후 2시간이내측정한검 78 www.labmedonline.org
사결과를 Table 1에정리하였다. 21종의검사항목 (WBC, RBC, Hb, Hct, MCV, MCH, RDW, HDW, CH, CHDW, PLT, MPV, PDW, Pct, Neutro, Lympho, Mono, Eos, Baso, LUC, MPXI) 에서는 와 을이용한측정값간에통계적으로유의한차이가없었던반면 (P >0.05), 3가지항목 (MCHC, CHCM, LI) 에서는서로유의한차이를보였다 (P <0.05). 두채혈관간검사결과는유의한양의상관관계를보였는데 (0.679 r 0.999, P <0.001), MCHC, LI에서는상대적으로약한상관관계 (0.224 r 0.570, P <0.001) 를보였다 [4]. nrbc의경우모든검체에서확인되지않았다 (Table 1). 일반혈액검사의경우채혈후 2시간이내검사결과와 1일냉장보관후결과비교시대부분의결과에서결과의상관성이유지되었는데, 에서는 MPV, Pct, Eos의 3가지항목에서, 에서는 HDW, CHCM, MPV, Pct, Eos 등 5가지항목에서통계적으로유의한차이를보였다 (P <0.05) (Table 2). 2. SST tube 와 의 SST 진공채혈관을이용하여시행한일반화학검사 24종 (CRP, AST, ALT, ALP, GGT, T-Bil, D-Bil, Ca, Mg, P, Fe, UIBC, TP, Alb, Glu, UA, LDH, CK, BUN, Cre, T. Chol, TG, HDL, LDL) 과갑상선기능검사 3종 (T3, FT4, TSH) 에대한두진공채혈관의채혈후 2시간이내측정한검사결과비교는 Table 3에정리하였다. 27종의검사에서 에비해 을이용한측정값간에통계적으로유의한차이가없었으며 (P >0.05), 두채혈관간검사결과는통계적으로유의하게강한양의상관관계를보였다 (0.833 r 0.999, P <0.001) [4] (Table 3). 일반화학검사와갑상선기능검사를채혈후 2시간이내검사결과와 1일냉장보관후결과를비교한자료에서는대부분의결과에서결과의상관성이유지되었으나, 에서는칼슘, T3의두항목에서, 에서는칼슘한항목에서두군간통계 Table 1. Comparison of the complete blood count test results between those of and tubes Mean bias (95% CI) Difference % P* r Allowable difference range WBC, 10 3 /μl 6.22±1.49 6.3±1.54-0.08 (-0.63 0.47) -1.28 0.774 0.988 ±15% RBC, 10 6 /μl 4.64±0.61 4.66±0.42-0.02 (-0.21 0.17) -0.41 0.842 0.746 ±6% Hb, g/dl 14.53±1.30 14.45±1.29 0.08 (-0.39 0.55) -0.54 0.742 0.988 ±7% Hct, % 42.17±3.53 41.31±3.58 0.87 (-0.42 2.15) -2.05 0.185 0.966 ±6% MCV, fl 89.98±3.56 88.72±3.52 1.26 (-0.03 2.54) -1.39 0.055 0.874 ±2.3% MCH, pg 31±1.51 31.07±1.68-0.07 (-0.65 0.51) -0.22 0.815 0.928 ±2.7% MCHC, g/dl 34.44±0.82 35±1.11-0.56 (-0.91-0.21) -1.63 0.002 0.570 ±2.2% RDW, % 12.86±0.67 12.86±0.65 0.01 (-0.23 0.25) -0.05 0.956 0.988 ±4.6% HDW, % 02.43±0.19 2.46±0.19-0.02 (-0.09 0.04) -1.02 0.472 0.990 NA CHCM, g/dl 34.08±0.84 34.79±0.83-0.72 (-1.02-0.41) -2.1 0.000 0.978 NA CH, pg 30.53±1.49 30.74±1.50-0.21 (-0.75 0.33) -0.68 0.448 0.999 NA CHDW, % 3.5±0.22 3.55±0.16-0.04 (-0.11 0.03) -1.17 0.245 0.784 NA PLT, 10 3 /μl 242.77±44.03 242.92±44.83-0.15 (-16.21 15.91) -0.06 0.985 0.970 ±25% MPV, fl 7.24±0.66 7.15±0.73 0.09 (-0.17 0.34) 1.2 0.498 0.943 ±5.8% PDW, fl 55.71±6.53 55.73±6.61-0.02 (-2.4 2.36) -0.04 0.987 0.810 NA Pct, % 0.17±0.03 0.17±0.03 0.00 (-0.01 0.01) -1.05 0.717 0.929 NA Neutro, % 57.03±7.93 57.07±7.85-0.04 (-2.89 2.81) -0.07 0.978 0.987 Target±3SD Lympho, % 33.1±6.7 32.97±6.77 0.13 (-2.3 2.57) 0.4 0.914 0.985 Target±3SD Mono, % 4.9±0.91 5.11±0.99-0.21 (-0.55 0.13) -4.29 0.230 0.833 Target±3SD Eos, % 2.48±1.89 2.32±1.54-0.16 (-0.47 0.78) -6.33 0.620 0.679 Target±3SD Baso, % 0.47±0.25 0.43±0.22-0.05 (-0.04 0.13) -9.51 0.298 0.744 Target±3SD LUC, % 2.02±0.57 1.9±0.49-0.12 (-0.07 0.31) -5.78 0.230 0.781 NA nrbc/100 WBC 0 0 0 0 0 0 LI 2.32±0.11 2.27±0.14 0.05 (0 0.09) -2.03 0.040 0.244 NA MPXI -2.13±2.74-1.93±2.81-0.19 (-1.19 0.81) -9.02 0.706 0.832 NA *P-values were determined by using the paired t-test; r data were determined by Pearson s correlation with a P-value of <0.001; Allowable difference range extrapolated from Clinical Laboratory Improvement Act/College of American Pathologists (CLIA/CAP) participant surveys. Abbreviations: WBC, White blood cell count; RBC, Red blood cell count; Hb, hemoglobin; Hct, hematocrit; MCV, mean corpuscular volume; MCH, mean corpuscular hemoglobin; MCHC, mean corpuscular hemoglobin concentration; RDW, red cell distribution width; HDW, hemoglobin distribution width; CHCM, cell hemoglobin concentration mean; CH, cellular hemoglobin; CHDW, cell hemoglobin distribution width; PLT, platelet; MPV, mean platelet volume; PDW, platelet distribution width; Pct, platelet-crit; Neutro, neutrophil; Lympho, lymphocyte; Mono, monocyte; Eos, eosinophil; Baso, basophil; LUC, large unstained cell; nrbc, nucleated red blood cell; LI, lobularity index; MPXI, mean peroxidase activity index; SD, standard deviation; CI, confidence interval. www.labmedonline.org 79
Table 2. Daily variations of complete blood count results between day 0 and day 1 obtained from and tubes Mean bias (95% CI) Difference % P* Mean bias (95% CI) Difference % P* WBC, 10 3 /μl 0.02 (-0.51 0.55) 0.25 0.953 0.04 (-0.51 0.59) 0.66 0.881 RBC, 10 6 /μl -0.06 (-0.25 0.13) -1.31 0.526 0.01 (-0.14 0.16) 0.18 0.910 Hb, g/dl -0.02 (-0.5 0.45) -0.16 0.923 0.02 (-0.46 0.50) 0.15 0.929 Hct, % -0.14 (-1.44 1.17) -0.32 0.836-0.1 (-1.39 1.20) -0.23 0.883 MCV, fl -0.06 (-1.34 1.21) -0.07 0.920-0.35 (-1.62 0.91) -0.40 0.582 MCH, pg 0.03 (-0.49 0.56) 0.11 0.895 0.01 (-0.57 0.59) 0.03 0.973 MCHC, g/dl 0.05 (-0.23 0.34) 0.15 0.719 0.14 (-0.21 0.49) 0.4 0.437 RDW, % 0.05 (-0.18 0.29) 0.41 0.657 0.08 (-0.16 0.31) 0.61 0.508 HDW, % 0.05 (-0.01 0.12) 2.19 0.120 0.07 (0.01 0.14) 2.95 0.034 CHCM, g/dl 0.18 (-0.12 0.48) 0.53 0.231 0.36 (0.06 0.65) 1.02 0.018 CH, pg 0.15 (-0.39 0.68) 0.48 0.589 0.2 (-0.35 0.74) 0.64 0.474 CHDW, % 0 (-0.07 0.07) -0.11 0.914 0.03 (-0.03 0.09) 0.73 0.392 PLT, 10 3 /μl -11.08 (-27.52 5.35) -4.57 0.184-8.92 (-25.44 7.61) -3.67 0.287 MPV, fl -0.75 (-1.02-0.49) -10.38 0.000-0.88 (-1.17-0.59) -12.3 0.000 PDW, fl 0.67 (-1.76 3.09) 1.20 0.587-0.16 (-2.52 2.19) -0.29 0.891 Pct, % -0.03 (-0.04-0.01) -14.91 0.000-0.03 (-0.04-0.02) -16.52 0.000 Neutro, % -0.45 (-3.31 2.4) -0.79 0.755-0.28 (-3.16 2.6) -0.49 0.847 Lympho, % 0.94 (-1.48 3.37) 2.85 0.443 0.64 (-1.83 3.1) -1.94 0.609 Mono, % 0.21 (-0.15 0.58) 4.36 0.249 0.24 (-0.14 0.62) -4.67 0.214 Eos, % -0.77 (-1.44-0.1) -31.04 0.025-0.81 (-1.45-0.17) -34.94 0.014 Baso, % 0.03 (-0.06 0.12) 6.69 0.474-0.07 (-0.16 0.02) -16.34 0.124 LUC, % 0.02 (-0.19 0.22) 0.83 0.871 0.1 (-0.1 0.29) 5.17 0.319 nrbc/100 WBC 0 0 0.000 0 0 0 LI 0.75 (0.69 0.81) 32.3 0.000 0.7 (0.64 0.76) 30.89 0.000 MPXI 0.89 (-0.22 1.99) -41.65 0.114 0.17 (-0.98 1.31) -8.53 0.775 *P-values were determined by using the paired t-test. Abbreviations: WBC, White blood cell count; RBC, Red blood cell count; Hb, hemoglobin; Hct, hematocrit; MCV, mean corpuscular volume; MCH, mean corpuscular hemoglobin; MCHC, mean corpuscular hemoglobin concentration; RDW, red cell distribution width; HDW, hemoglobin distribution width; CHCM, cell hemoglobin concentration mean; CH, cellular hemoglobin; CHDW, cell hemoglobin distribution width; PLT, platelet; MPV, mean platelet volume; PDW, platelet distribution width; Pct, platelet-crit; Neutro, neutrophil; Lympho, lymphocyte; Mono, monocyte; Eos, eosinophil; Baso, basophil; LUC, large unstained cell; nrbc, nucleated red blood cell; LI, lobularity index; MPXI, mean peroxidase activity index; CI, confidence interval. 적으로유의한차이를보였다 (P <0.05) (Table 4). 고찰 플라스틱채혈관의개발로유리채혈관을대체하게된후국내에서는대부분수입제품에의존하여사용하고있었는데, 수입에따른문제나비용문제등을해결하기위하여국산화를하기위한노력들로여러업체들의채혈관이소개되었다 [2, 5]. 본연구에서는 Medion사에서개발된 국산채혈관을국내에서널리이용되는 BD사의 채혈관과비교분석하였다. 본연구결과에서 MCHC가 CLIA 88에서제시하는임상적으로허용되는오차범위 [6] 를벗어나는차이를보이는두검체는 BD Vacutainer 에비해 에서각각 -3.8, -6의차이를보였다 (Fig. 1). MCHC는 Hb/Hct로계산이되는데, Hct의작은차이에의해서도 MCHC의차이를크게발생시킬수있다 [7]. 검사결과의차이를 발생시킨검체의결과를분석해보면, Hb는 에비해 에서 0.3 g/dl만큼높거나, 0.1 g/dl만큼낮았고, Hct는 Vacutainer에비해 에서 5.2%, 4.1% 만큼낮은값을보여허용되는오차범위이내의차이를보였다. nrbc의경우모든검사에서 0 의값이기록되었는데, 건강한성인을대상으로한검사였기때문으로생각되었다. 채혈관의안정성을확인하기위하여두시험관을하루동안냉장보관한후동일한검사를반복실시한값을비교했을때, CBC 에서 MPV, Pct, Eos의 3가지항목은두채혈관모두결과값의유의한변화를보였으며, 에서는추가로 HDW, CHCM의결과값이통계적으로상관성이떨어지는결과를보였는데이는앞선연구와유사한결과였다 [8]. 일반화학검사에서는양채혈관모두에서칼슘의결과가즉시검사한결과보다낮은결과를보였는데, 이는기존연구에서 BD tube의칼슘에대한 day 1 안정성과다른결과였다 [2, 9]. 이는채혈관성능의문제인지분석과정의다른단계 80 www.labmedonline.org
Table 3. Comparison of routine chemistry and thyroid function test results between those of and tubes Mean bias (95% CI) D ifference % P* r Allowable difference range CRP, mg/dl 0.10±0.18 0.10±0.19 0 (-0.07 0.07) 0.17 0.996 0.999 ±30% AST, U/L 18.56±6.48 18.66±6.48-0.1 (-2.4 2.21) -0.52 0.934 0.982 ±20% ALT, U/L 18.94±12.25 18.89±12.36 0.05 (-4.33 4.42) 0.26 0.983 0.998 ±20% ALP, U/L 57.61±15.81 57.63±15.93-0.02 (-5.66 5.63) -0.03 0.995 0.992 ±30% GGT, U/L 27.63±32.48 27.5±32.81 0.13 (-11.48 11.74) 0.47 0.982 0.999 ±10% T. Bil, mg/dl 0.65±0.41 0.65±0.41 0 (-0.14 0.15) 0.37 0.974 0.998 ±20% D. Bil, mg/dl 0.25±0.12 0.28±0.14-0.03 (-0.07 0.02) -10.3 0.262 0.991 ±30% Ca, mg/dl 9.4±0.31 9.39±0.3 0.01 (-0.1 0.12) 0.07 0.907 0.878 ±1.00 Mg, mg/dl 2±0.14 2.01±0.15-0.01 (-0.07 0.04) -0.73 0.578 0.913 ±25% P, mg/dl 3.49±0.63 3.49±0.63 0 (-0.22 0.22) 0.00 0.999 0.997 ±12% Fe, μg/dl 107.16±44.16 106.84±44.17 0.32 (-15.38 16.03) 0.30 0.968 0.999 ±20% UIBC, μg/dl 223.52±61.65 224.65±61.95-1.13 (-23.1 20.84) -0.51 0.919 0.995 ±25% TP, g/dl 6.89±1.24 6.89±1.25 0.01 (-0.43 0.45) 0.12 0.971 0.878 ±10% Alb, g/dl 4.76±0.24 4.77±0.24-0.01 (-0.1 0.08) -0.2 0.823 0.947 ±10% Glu, mg/dl 101.19±16.85 101.32±16.8-0.13 (-6.11 5.85) -0.13 0.966 0.991 ±10% UA, mg/dl 5.64±1.47 5.63±1.51 0.01 (-0.52 0.54) 0.11 0.981 0.997 ±17% LDH, U/L 175.61±24.14 171.9±23.92 3.71 (-4.83 12.25) 2.11 0.392 0.833 Target±3SD CK, U/L 116.23±69.81 117.16±70.27-0.94 (-25.84 23.97) -0.8 0.941 0.999 ±30% BUN, mg/dl 12.77±3.56 12.87±3.59-0.1 (-1.37 1.17) -0.8 0.874 0.993 ±9%0 Cre, mg/ml 0.82±0.16 0.83±0.16-0.01 (-0.07 0.04) -1.6 0.646 0.980 ±15% T. Chol, mg/dl 187.48±37.68 188.06±38.17-0.58 (-14.06 12.9) -0.31 0.932 0.995 ±10% TG, mg/dl 141.44±95.55 140.87±94.97 0.56 (-33.3 34.43) 0.4 0.974 0.999 ±25% HDL, mg/dl 57.31±16.14 57.69±16.32-0.39 (-6.16 5.38) -0.68 0.895 0.991 ±30% LDL, mg/dl 116.6±33.4 117.18±33.87-0.58 (-12.54 11.38) -0.5 0.924 0.999 ±30% T3, ng/ml 0.92±0.12 0.93±0.11 0.00 (-0.05 0.04) -0.35 0.860 0.938 Target±3SD FT4, ng/dl 1.28±0.16 1.26±0.16 0.01 (-0.04 0.08) 1.14 0.532 0.928 Target±3SD TSH, μiu/ml 1.92±1.15 1.94±1.14-0.02 (-0.41 0.37) -0.94 0.921 0.998 Target±3SD *P-values were determined by using the paired t-test; r data were determined by Pearson s correlation with a P-value of <0.001; Allowable difference in the range extrapolated from Clinical Laboratory Improvement Act/College of American Pathologists (CLIA/CAP) participant surveys. Abbreviations: CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, gamma-glutamyltransferase; T-Bil, total bilirubin; D-Bil, direct bilirubin; Ca, calcium; Mg, magnesium; P, phosphorus; Fe, ferrous iron; UIBC, unsaturated iron binding capacity; TP, total protein; Alb, albumin; Glu, glucose; UA, uric acid; LDH, lactate dehydrogenase; CK, creatine kinase; BUN, blood urea nitrogen; Cre, creatinine; T. Chol, total cholesterol; TG, triglyceride; HDL, high density lipoprotein; LDL, low density lipoprotein; T3, triiodothyronine; FT4, free thyroxine; TSH, thyroid stimulating hormone; SD, standard deviation; CI, confidence interval. 에서발생한차이인지를밝히는추가연구가필요할것으로판단되었다. 갑상선기능검사에서도 T3가양쪽 tube 모두에서하루가지난후결과가달라졌는데, 앞선연구에서갑상선기능검사의경우채혈후두시간이내검체로검사하는것을원칙으로하는것이안정적인결과를보이고, 시간이경과한검체로검사를시행하는경우에는그해석에주의를기울여야한다고설명하고있다 [10]. 결론적으로, 본연구에서는 Medion사의 의검사결과가 BD사의 BD Vacu-tainer 의검사결과와대체적으로높은상관성을보였다. MCHC, CHCM, LI의결과에서차이를보였는데, MCHC의경우이차이는 Hct의차이로인해발생한차이로해석된다. 24시간보관후결과를비교평가했을때, 과 의성능은서로임상적으로의미있는수준의차이를보이지는않았다. 양채혈관모두에서 24시간보관후검사를시행하였을때의 차이는검사실에서일반적으로채혈관을사용하는데에는유의한차이가아닌것으로보인다. 본연구의제한점으로는충분한비교검체수확보가어려웠으며, 건강한성인만을대상으로진행하여다양한환자군에서의채혈관성능에대한확인이어려웠던점, 그리고검체안정성평가를위한다양한보관기간별평가를진행하지못한점등을들수있다. 성능비교평가에서유의한차이를보이지않는다면, 국산제품은운송과정등의단축으로인한채혈관손상의최소화및경제적측면에서장점을가질수있으리라판단된다. 연구제한점을고려하여차이를보였던종목에대한추적검사와보다다양한농도범위를활용한비교와추가안정성에대한연구가필요할것으로생각된다. www.labmedonline.org 81
Table 4. Daily variations of routine chemistry and thyroid functioning test results between day 0 and day 1 obtained from and tubes Mean bias (95% CI) Difference % P* Mean bias (95% CI) Difference % P* CRP, mg/dl 0 (-0.07 0.07) -0.17 0.996 0 (-0.07 0.07) -1.34 0.969 AST, U/L 18.47 (-2.81 1.84) -2.61 0.682-0.6 (-2.91 1.72) -3.2 0.611 ALT, U/L 18.84 (-3.96 4.74) 2.04 0.861 0.21 (-4.19 4.61) 1.11 0.925 ALP, U/L 57.52 (-6.13 5.13) -0.87 0.861-0.44 (-6.04 5.17) -0.76 0.878 GGT, U/L 27.53 (-11.52 11.58) 0.12 0.996 0.03 (-11.58 11.64) 0.12 0.996 T. Bil, mg/dl 0.56 (-0.13 0.15) 1.78 0.872 0.01 (-0.13 0.16) 1.74 0.879 D. Bil, mg/dl 0.16 (-0.03 0.05) 4.8 0.571 0.02 (-0.03 0.06) 6.21 0.474 Ca, mg/dl 9.3 (-0.27-0.03) -1.58 0.015-0.19 (-0.31-0.07) -2.06 0.002 Mg, mg/dl 1.9 (-0.07 0.04) -0.84 0.525-0.03 (-0.08 0.03) -1.26 0.360 P, mg/dl 3.4 (-0.21 0.23) 0.27 0.932 0 (-0.22 0.22) 0.05 0.987 Fe, μg/dl 107.06 (-16.77 14.65) -0.99 0.894-1.77 (-17.57 14.02) -1.66 0.824 UIBC, μg/dl 223.42 (-30.34 13.37) -3.8 0.444-8.13 (-30.12 13.86) -3.62 0.466 TP, g/dl 6.8 (-0.41 0.49) 0.61 0.853 0.01 (-0.44 0.46) 0.09 0.977 Alb, g/dl 4.67 (-0.08 0.09) 0.14 0.878 0.01 (-0.08 0.1) 0.2 0.827 Glu, mg/dl 101.1 (-4.18 7.73) 1.75 0.556 1.42 (-4.52 7.36) 1.4 0.637 UA, mg/dl 5.54 (-0.47 0.58) 0.94 0.842 0.06 (-0.48 0.6) 1.12 0.818 LDH, U/L 175.52 (-12.86 4.19) -2.47 0.316-4.84 (-13.36 3.69) -2.81 0.263 CK, U/L 116.13 (-25.02 24.66) -0.15 0.989 0.44 (-24.39 25.26) 0.37 0.972 BUN, mg/dl 12.67 (-1.77 0.79) -3.84 0.449-0.43 (-1.72 0.85) -3.37 0.505 Cre, mg/ml 0.72 (-0.08 0.04) -2.36 0.501-0.01 (-0.07 0.05) -1.3 0.708 T. Chol, mg/dl 187.39 (-16.13 10.55) -1.49 0.68-1.39 (-14.7 11.92) -0.74 0.837 TG, mg/dl 141.34 (-38.5 31.82) -2.36 0.851-1.66 (-35.34 32.02) -1.18 0.922 HDL, mg/dl 57.21 (-4.52 6.72) 1.91 0.700 0.55 (-5.18 6.28) 0.95 0.850 LDL, mg/dl 116.5 (-11.07 12.75) 0.72 0.889 1.21 (-10.75 13.17) 1.03 0.842 T3, ng/ml -0.06 (-0.09 0.00) -6.36 0.045-0.05 (-0.08 0.00) -5.66 0.064 FT4, ng/dl -0.02 (-0.06 0.06) -1.2 0.915 0.01 (-0.05 0.05) 0.76 0.704 TSH, μiu /ml 0.03 (-0.35 0.42) 1.67 0.863 0.03 (-0.35 0.42) 1.57 0.869 *P-values were determined by using the paired t-test. Abbreviations: CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, gamma-glutamyltransferase; T-Bil, total bilirubin; D-Bil, direct bilirubin; Ca, calcium; Mg, magnesium; P, phosphorus; Fe, ferrous iron; UIBC, unsaturated iron binding capacity; TP, total protein; Alb, albumin; Glu, glucose; UA, uric acid; LDH, lactate dehydrogenase; CK, creatine kinase; BUN, blood urea nitrogen; Cre, creatinine; T. Chol, total cholesterol; TG, triglyceride; HDL, high density lipoprotein; LDL, low density lipoprotein; T3, triiodothyronine; FT4, free thyroxine; TSH, thyroid stimulating hormone; CI, confidence interval.. Difference MCHC 2 ULOA 1 0-1 32-2 -3-4 -5-6 -7 34 36 Average38 LLOA A Difference CHCM 0.4 0.2 0-0.2-0.4 ULOA -0.6-0.8 32-1.0-1.2 34 36 Average38 LLOA B Difference LI 1.0 0.8 0.6 0.4 ULOA 0.2 0 1.5-0.2-0.4 2 2.5 Average LLOA 3 C Fig. 1. Bland-Altman plot of the difference of results between and (A) mean corpuscular hemoglobin concentration (MCHC), (B) cell hemoglobin concentration mean (CHCM), (C) lobularity index (LI). Abbreviations: ULOA, upper limit of agreement; LLOA, lower limit of agreement. 82 www.labmedonline.org
요약 REFERENCES 배경 : 대부분의검사실에서이루어지는혈액검사는진공채혈관을이용해서이루어지고있다. 본연구는새롭게개발된 (Medion, Korea) 과 (BD, USA) 를이용하여혈액, 화학, 그리고면역검사를비교분석하였다. 방법 : 총 33명의남자와 27명의여자로구성된 60명의건강한지원자들에서두회사의진공채혈관에검체를채취하였다. EDTA 채혈관은 25종의혈액분야검사를하는데이용되었고, Serum separating tube는 24종의화학검사와 3종의갑상선기능검사를하는데이용되었다. 결과는 paired t-test와 Bland-Altman plot을이용하여분석하였다. 추가적으로, 각채혈관의안정성을평가하기위해채혈당일과 24시간후의결과를비교하였다. 결과 : 두채혈관에대한 25종의혈액분야검사, 24종의화학검사, 3 종의갑상선기능검사를 paired t-test로분석한결과높은일치도를보였다. 제품에비해 진공채혈관에서 2 종의혈액분야검사 (MCHC, CHCM) 의평균이높게측정되었고 1종의혈액분야검사 (LI) 의평균이낮게측정되었다. 당일검체와 24시간보관검체를비교한결과에서는두제품에서비슷한결과를내었는데, 에서는 MPV, Pct, eosinophil, calcium, triiodothyronine에서, 진공채혈관에서는 MPV, HDW, CHCM, Pct, eosinophil, calcium에서통계적으로차이를보였다. 결론 : 와 을사용한검사는몇가지의혈액검사 (MCHC, CHCM, LI) 에서차이를보였으며나머지검사들은비슷한성능을보였다. 이해관계 저자들은본연구와관련하여어떠한이해관계도없음을밝힙니다. 1. Narayanan S. The preanalytic phase. An important component of laboratory medicine. Am J Clin Pathol 2000;113:429-52. 2. Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side of the moon in laboratory testing. Clin Chem Lab Med 2006; 44:358-65. 3. Oh SH and Ki CS. Comparison of two new plastic tubes (Sekisui INSE- PACK and Green Cross Green Vac-Tube) with tubes for 49 analytes. Korean J Lab Med 2007;27:69-75. 4. Landis JR and Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159-74. 5. 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;30:307-14. 6. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)-HCFA. Final rule with comment period. Fed Regist 1992;57:7002-186. 7. Hill VL, Simpson VZ, Higgins JM, Hu Z, Stevens RA, Metcalf JA, et al. Evaluation of the performance of the Sysmex XT-2000i hematology analyzer with whole bloods stored at room temperature. Lab Med 2009; 40:709-18. 8. Pinter E, Laszlo K, Schuszler I, Konderak J. The stability of quantitative blood count parameters using the ADVIA 2120i hematology analyzer. Pract Lab Med 2015;4:16-21. 9. Won EJ, Shin MG, Jang MJ, Cho D, Kee SJ, Kim SH, et al. Comparison between V-tubes and tubes for use in laboratory tests. Lab Med Online 2013;3:145-54. 10. Ismail Y, Ismail AA, Ismail AA. Erroneous laboratory results: what clinicians need to know. Clin Med (Lond) 2007;7:357-61. www.labmedonline.org 83