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Jhang, Cho, Lee, and Kim: Comparison between Medion Vacuon Tube and BD Vacutainer Tube for Clinical Laboratory Practice
Original Article

Lab Med Online 2019;9(2):77-83.

Published online: 20 April 2019

DOI: https://doi.org/10.3343/lmo.2019.9.2.77

Comparison between Medion Vacuon Tube and BD Vacutainer Tube for Clinical Laboratory Practice

Jinho Jhang, M.D., Ju Young Cho, M.D., Jong-Han Lee, M.D., Juwon Kim, M.D.

Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea

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 7 March 2018       Revised 7 August 2018       Accepted 30 October 2018

Copyright © 2019 The Korean Society for Laboratory Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Most of the blood-test samples are collected and carried in vacuum tubes. We have compared a newly developed vacuum tube, ‘Vacuon' (Medion, Korea) and ‘BD Vacutainer®' (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 Vacuon than BD Vacutainer (t=0 hr). The results after 24 hr showed similarity between the 2 brands, with some inconsistent results in BD Vacutainer (Mean platelet volume [ MPV], plateletcrit [ Pct], eosinophil, calcium, and triiodothyronine) and Vacuon (MPV, hemoglobin distribution width [ HDW], CHCM, Pct, eosinophil, and calcium).

Conclusions

BD Vacutainer and Vacuon tube showed good statistical concordance rate with some exceptions in the hematological parameters (MCHC, CHCM, and LI).

Keywords: Comparison, Vacuum tube, Concordance, Parameters

References

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Fig. 1.
Bland-Altman plot of the difference of results between BD Vacutainer and Vacuon (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.
lmo-9-77f1.tif
Table 1.
Comparison of the complete blood count test results between those of BD Vacutainer and Vacuon tubes
  BD Vacutainer (mean±SD) Vacuon (mean±SD) Mean bias (95% CI) Difference % P∗ r† Allowable difference range‡
WBC, ×103/μL 6.22±1.49 6.3±1.54 –0.08 (−0.63–0.47) –1.28 0.774 0.988 ±15%
RBC, ×106/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, ×103/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.

Table 2.
Daily variations of complete blood count results between day 0 and day 1 obtained from BD Vacutainer and Vacuon tubes
  BD Vacutainer Vacuon
  Mean bias (95% CI) Difference % P∗ Mean bias (95% CI) Difference % P∗
WBC, ×103/μL 0.02 (−0.51–0.55) 0.25 0.953 0.04 (−0.51–0.59) 0.66 0.881
RBC, ×106/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, ×103/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.

Table 3.
Comparison of routine chemistry and thyroid function test results between those of BD Vacutainer and Vacuon tubes
  BD Vacutainer (mean±SD) Vacuon (mean±SD) 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.

Table 4.
Daily variations of routine chemistry and thyroid functioning test results between day 0 and day 1 obtained from BD Vacutainer and Vac-uon tubes
  BD Vacutainer Vacuon
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.

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