Journal List > Korean J Lab Med > v.27(1) > 1011443

Oh and Ki: Comparison of Two New Plastic Tubes (Sekisui INSEPACK and Green Cross Green Vac-Tube) with BD Vacutainer Tubes for 49 Analytes

Abstract

Background

Becton Dickinson (BD) Vacutainer tubes are the most widely used vacuum system for collection of blood in clinical laboratories. We compared the performance of two new tubes, Sekisui INSEPACK tube and Green Cross Green Vac-Tube, with the existing BD Vacutainer tubes for 49 common analytes.

Methods

A total of 20 apparently healthy volunteers were recruited for this study. For rountine chemistry and thyroid function tests, we compared the results of two new vacutainer tubes and BD Vacutainer tubes with those of BD glass tubes at t = 0 hr by student paired t test. Hematology and coagulation test results of the two new vacutainer tubes were compared with those of BD Vacutainer tubes at t =0 hr. To study the stability of each analyte, results at t = 24±2 hr, t = 72±2 hr, and t=168 ±2 hr were compared with those at t = 0 hr for each tube.

Results

Although paired t test analysis revealed statistically significant differences between two tested tubes and existing BD Vacutainer tube in several tests (total protein, total bilirubin, alkaline phosphatase, glucose, uric acid, calcium, inorganic phosphorus, direct bilirubin, triglyceride, HDL-cholesterol, LDL-cholesterol, lactate dehydrogenase, triiodothyronine, and thyroxine), these differences were not considered clinically significant. Stability of two new vacuum tubes for each analyte was similar to that of the BD Vacutainer tube.

Conclusions

Sekisui INSEPACK tube and Green Cross Green-Vac Tube showed a satisfactory analytical performance compared with existing BD Vacutainer tubes. We conclude that these two new plastic vacutainer tubes are acceptable for the commonly ordered laboratory tests.

References

1. Reinartz JJ, Ramey ML, Fowler MC, Killeen AA. Plastic vs glass SST evacuated serum-separator blood-drawing tubes for endocrinologic analytes. Clin Chem. 1993; 39:2535–6.
crossref
2. Henry JB, Kurec AS. The clinical laboratory: organization, purposes, and practice. Henry JB, editor. Clinical diagnosis and management by laboratory methods. 20th ed.Philadelphia: WB Saunders;2001. p. 13–7.
3. Boeynaems JM, De Leener A, Dessars B, Villa-Lobos HR, Aubry JC, Cotton F, et al. Evaluation of a new generation of plastic evacuated blood-collection tubes in clinical chemistry, therapeutic drug monitoring, hormone and trace metal analysis. Clin Chem Lab Med. 2004; 42:67–71.
crossref
4. Smets EM, Dijkstra-Lagemaat JE, Blankenstein MA. Influence of blood collection in plastic vs. glass evacuated serum-separator tubes on hormone and tumour marker levels. Clin Chem Lab Med. 2004; 42:435–9.
crossref
5. Landt M, Wilhite TR, Smith CH. A new plastic evacuated tube with plasma separator. J Clin Lab Anal. 1995; 9:101–6.
crossref
6. Van Cott EM, Lewandrowski KB, Patel S, Grzybek DY, Patel HS, Fletcher SR, et al. Comparison of glass K3EDTA versus plastic K2E-DTA blood-drawing tubes for complete blood counts, reticulocyte counts, and white blood cell differentials. Lab Hematol. 2003; 9:10–4.
7. 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; 130:39–44.
crossref
8. Hill BM, 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; 38:1474–8.
9. 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.
10. Zhang DJ, Elswick RK, Miller WG, Bailey JL. Effect of serum-clot contact time on clinical chemistry laboratory results. Clin Chem. 1998; 44:1325–33.
crossref
11. Fraser CG, editor. Biological variation: From principles to practice. Washington, D.C.: AACC press;2001. p. 50–4. 133–41.
12. Laessig RH, Westgard JO, Carey RN, Hassemer DJ, Schwartz TH, Feldbruegge DH. Assessment of a serum separator device for obtaining serum specimens suitable for clinical analyses. Clin Chem. 1976; 22:235–9.
crossref
13. 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; 51:424–33.
crossref
14. Gosselin RC, Janatpour K, Larkin EC, Lee YP, Owings JT. Comparison of samples obtained from 3.2% sodium citrate glass and two 3.2% sodium citrate plastic blood collection tubes used in coagulation testing. Am J Clin Pathol. 2004; 122:843–8.
crossref

Table 1.
Evaluated vacutainer tubes and tested analytes
Additives Brand Cat. No. Draw volume Wall material Analytes
Serum separating gel clot activator BD Vacutainer 367989 5 mL Plastic total protein, albumin, globulin, A/G ratio, cholesterol, total bilirubin, AST, ALT, ALP, glucose, BUN, Cr, uric acid, calcium, inorganic phosphorus, direct bilirubin, GGT, Na, K, Cl, HCO3, Fe, UIBC, Mg, hsCRP, TG, HDL-cholesterol, LDL-cholesterol, CK, LD, T3, T4, TSH, free T4
  Sekisui INSEPACK ST740C 4 mL Plastic  
  Green Cross Green Vac-Tube GV0225 5 mL Plastic  
EDTA-K2 BD Vacutainer 367844 4 mL Plastic WBC, RBC, hemoglobin, hematocrit, MCV, MCHC, RDW, neutrophil (%), lymphocyte (%), monocyte (%), eosinophil (%), basophil (%), ESR
  Sekisui INSEPACK ST520EK 2 mL Plastic  
  Green Cross Green Vac-Tube GV0312 2 mL Plastic  
3.2% sodium citrate BD Vacutainer 366415 4.5 mL Glass PT, aPTT
  Sekisui INSEPACK ST527SC 2.7 mL Plastic  
  Green Cross Green Vac-Tube GV0512 2.7 mL Plastic  

Abbreviations: A/G, albumin/globulin; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; BUN, blood urea nitrogen; Cr, creatinine; GGT, gamma glutamyltranspeptidase; Na, sodium; K, potassium; Cl, chloride; HCO3, bicarbonate; Fe, iron; UIBC, unsaturated iron-binding capacity; Mg, magnesium; hsCRP, high-sensitivity C-reactive protein; TG, triglyceride; HDL, high density lipoprotein; LDL, low density lipoprotein; CK, creatine kinase; LD, lactate dehydrogenase; T3, triiodothyronine; T4, thyroxine; TSH, thyroid stimulating hormone; WBC, white blood cell count; RBC, red blood cell count; MCV, mean corpuscular volume; MCHC, mean corpuscular hemoglobin concentration; RDW, red cell distribution width; ESR, erythrocyte sedimentation rate; PT, prothrombin time; aPTT, activated partial thromboplastin time.

Table 2.
Comparing the difference in chemistry test results obtained from glass and three plastic collection tubes at t=0 (mean±SD)
  BD glass BD Vacutainer Sekisui INSEPACK Green Cross Green Vac P P P§
T. protein (g/dL) 7.27±0.34 7.35±0.35 7.34±0.33 7.30±0.32 0.002 <0.001 0.043
Albumin (g/dL) 4.40±0.21 4.42±0.23 4.42±0.23 4.35±0.23 0.125 0.244 0.166
Globulin (g/dL) 2.89±0.34 2.93±0.37 2.92±0.33 2.94±0.37 0.196 0.297 0.083
A/G ratio 1.56±0.19 1.53±0.21 1.53±0.20 1.49±0.21 0.447 0.33 0.062
Chol (mg/dL) 177.9±37.28 179.36±36.40 179.04±36.01 177.77±35.15 0.407 0.525 0.943
T. bilirubin (mg/dL) 0.62±0.9 0.65±0.30 0.65±0.29 0.65±0.30 <0.001 <0.001 <0.001
AST (U/L) 19.43±6.41 19.38±6.92 19.93±6.76 19.59±6.18 0.563 0.049 0.191
ALT (U/L) 18.45±16.73 18.19±15.83 17.99±15.88 18.19±15.84 0.7 0.124 0.199
ALP (U/L) 57.30±16.26 57.85±16.36 57.72±16.58 57.72±16.37 <0.001 0.015 0.009
Glucose (mg/dL) 84.44±9.4 86.25±7.98 86.17±8.97 86.35±8.51 0.023 0.035 0.008
BUN (mg/dL) 11.97±2.31 11.94±2.31 12.10±2.36 11.98±2.26 0.645 0.015 0.843
Cr (mg/dL) 0.86±0.12 0.84±0.12 0.85±0.11 0.86±0.11 0.044 0.921 0.128
Uric acid (mg/dL) 4.73±1.31 4.77±1.33 4.79±1.34 4.78±1.33 0.044 0.026 0.047
Calcium (mg/dL) 8.84±0.32 8.99±0.28 8.99±0.26 8.93±0.26 <0.001 0.003 0.024
IP (mg/dL) 3.09±0.57 3.12±0.56 3.17±0.56 3.13±0.55 0.035 0.001 0.006
D. bilirubin (mg/dL) 0.30±0.15 0.36±0.16 0.36±0.17 0.36±0.16 <0.001 <0.001 <0.001
GGT (U/L) 23.22±19.7 23.53±19.26 23.26±19.64 23.33±19.62 0.094 0.754 0.735
Na (mmol/L) 141.6±1.532 141.51±1.34 141.45±1.30 141.50±1.37 0.495 0.258 0.371
K (mmol/L) 4.05±0.16 4.11±0.20 4.08±0.17 4.12±0.19 0.167 0.175 0.116
Cl (mmol/L) 102.50±1.31 102.53±1.49 102.42±1.46 102.46±1.54 0.765 0.265 0.634
HCO3 (mmol/L) 28.08±2.25 27.89±2.13 27.85±2.06 27.47±2.09 0.296 0.16 0.003
Fe (μg/dL) 109.28±50.27 109.67±50.37 109.45±50.43 109.86±49.89 0.191 0.482 0.018
UIBC (μg/dL) 214.04±56.54 213.25±0.57 216.40±58.14 215.89±57.10 0.603 0.08 0.048
Mg (mg/dL) 2.07±0.13 2.08±0.15 2.12±0.03 2.07±0.13 0.413 <0.001 0.964
hsCRP (mg/dL) 0.04±0.05 0.05±0.05 0.04±0.05 0.04±0.05 0.024 0.349 0.214
TG (mg/dL) 109.97±59.82 111.52±59.99 113.20±60.35 112.97±59.73 0.032 <0.001 0.001
HDL-C (mg/dL) 60.38±12.95 60.80±12.60 61.46±12.85 61.14±12.99 0.009 <0.001 <0.001
LDL-C (mg/dL) 106.36±30.98 108.36±31.84 107.97±31.71 106.50±31.76 0.001 <0.001 0.701
CK (IU/L) 117.08±112.04 117.97±112.63 116.87±110.13 117.14±112.67 0.027 0.729 0.841
LD (U/L) 297.70±52.60 316.15±50.23 313.55±50.87 302.45±51.40 <0.001 <0.001 0.001
T3 (ng/mL) 1.37±0.27 1.50±0.27 1.44±0.30 1.43±0.29 <0.001 0.001 0.003
T4 (μg/dL) 8.23±1.97 8.96±2.18 8.90±2.28 8.71±2.11 <0.001 <0.001 <0.001
TSH (μIU/mL) 1.95±1.22 1.92±1.27 1.96±1.23 1.97±1.28 0.493 0.277 0.518
Free T4 (ng/dL) 1.24±0.14 1.25±0.14 1.25±0.14 1.24±0.12 0.053 0.177 0.297

* Data are given as mean±SD. Pvalues were determined by using the Student paired t test.

Comparison between BD Vacutainer and BD glass tube.

Comparison between Sekisui INSEPACK and BD glass tube.

§ Comparison between Green Cross Green Vac-Tube and BD glass tube.

Abbreviations: chol, cholesterol; T. bilirubin, total bilirubin; IP, inorganic phosphorus; D. bilirubin, direct bilirubin; HDL-C, high density lipoprotein-cholesterol; LDL-C, low density lipoprotein cholesterol; See Table 1 for the others.

Table 3.
Comparing the difference in routine hematology and coagulation test results obtained from BD Vacutainer and the two new plastic tubes at t=0 (mean±SD)
  BD Vacutainer Sekisui INSEPACK Green Cross Green Vac P P
WBC (× 103/μL) 5.39±1.06 5.39±1.03 5.42±1.06 0.899 0.324
RBC (× 1003/μL) 4.58±0.49 4.57±0.48 4.56±0.47 0.179 0.013
Hb (g/dL) 14.19±1.43 14.15±1.43 14.16±1.41 0.057 0.167
Hct (%) 43.01±3.98 43.09±3.96 43.04±3.74 0.364 0.732
MCV (fl) 94.05±4.27 94.51±4.26 94.67±4.28 <0.001 <0.001
MCHC (g/dL) 32.53±2.15 32.82±0.76 32.86±0.91 0.518 0.459
RDW (%) 12.77±0.73 12.77±0.73 12.78±0.73 0.841 0.694
Neutrophil (%) 52.85±8.46 52.69±8.48 52.99±8.52 0.573 0.632
Lymphocyte (%) 38.97±7.46 38.91±7.56 38.56±7.67 0.858 0.250
Monocyte (%) 5.45±1.35 5.52±1.20 5.71±1.35 0.792 0.391
Eosinophil (%) 2.34±1.89 2.43±1.86 2.33±1.69 0.166 0.839
Basophil (%) 0.40±0.21 0.46±0.23 0.43±0.30 0.051 0.412
ESR (mm/hr) 8.60±7.96 7.80±7.49 10.70±9.19 0.061 0.004
PT (sec) 13.64±0.61 13.48±0.55 13.52±0.61 0.001 0.018
aPTT (sec) 36.85±2.24 32.52±2.01 37.18±2.25 <0.001 0.002

* Data are given as mean ±SD. P values were determined by using the Student paired t test.

Comparison between Sekisui INSEPACK and BD Vacutainer tube.

Comparison between Green Cross Green Vac-Tube and BD Vacutainer tube.

Abbreviations: Hb, hemoglobin; Hct, hematocrit; See Table 1 for the others.

Table 4.
Stability of chemistry and thyroid function tests with the three vacuum tubes on day 1, day 3, and day 7 (% change compared with day 0)
  BD Vacutainer
Sekisui INSEPACK
Green Cross Green Vac-Tube
Day 1 Day 3 Day 7 Day 1 Day 3 Day 7 Day 1 Day 3 Day 7
T. protein 1.95 1.30 2.24 1.01 −0.46 2.48 0.85 −0.31 2.42
Albumin 1.77 3.11 3.73 2.62 2.02 3.86 3.77 1.45 3.10
Globulin 2.24 −1.92 −0.31 −1.55 −3.90 0.35 −3.38 −2.75 1.70
A/G ratio −0.79 4.70 4.88 4.86 7.37 5.40 8.34 5.21 3.47
Chol −0.53 1.99 3.00 −0.32 0.98 2.49 −0.75 0.12 1.68
T. bilirubin 0.36 −2.14 −1.84 0.28 −2.81 −5.51 −1.78 −6.29 −13.17
AST 6.24 12.47 13.03 3.60 5.31 12.22 7.12 4.54 14.73
ALT −15.5 −2.01 1.41 −10.6 1.30 6.28 −10.2 −4.91 0.01
ALP 1.11 1.68 3.09 0.96 0.87 2.20 0.33 0.36 3.88
Glucose 0.35 0.43 0.66 0.41 0.47 0.31 −1.77 −1.42 −1.97
BUN 2.62 −0.01 2.50 1.06 −2.04 1.50 1.43 −2.67 1.67
Cr −0.02 −2.20 −1.61 −0.47 −1.80 −1.90 −0.02 −2.39 −1.89
Uric acid 1.21 0.79 2.19 0.31 −0.14 0.51 −0.14 −0.71 −0.45
Calcium 6.10 1.69 2.41 5.53 1.42 0.69 1.27 1.09 0.58
IP 1.77 2.85 6.39 2.43 2.96 5.40 1.69 2.10 −0.31
D. bilirubin 0.77 −4.72 −5.32 0.79 −4.75 −10.44 −3.15 −12.0 −39.9
GGT −4.29 −1.36 6.66 −1.73 1.19 1.47 −3.00 −0.36 −6.62
Na 0.18 1.25 1.95 0.02 1.09 1.97 −0.06 0.66 1.51
K 0.45 3.41 12.13 0.16 1.59 5.49 0.09 1.38 8.22
Cl −0.04 0.81 0.90 −0.16 0.66 0.81 0.05 0.14 0.12
HCO3 −11.1 −22.8 −22.3 −11.4 −22.2 −23.7 −9.8 −20.0 −26.4
Fe 1.39 1.70 −1.47 2.14 2.53 3.07 1.41 1.60 −0.26
UIBC 5.63 4.32 5.33 6.26 4.07 4.76 4.95 4.56 6.05
Mg −0.22 −1.55 2.02 −1.85 −1.52 0.35 −0.56 −0.01 1.49
TG 3.04 −0.71 8.55 3.37 2.89 5.64 1.54 1.23 5.69
HDL-C −1.67 −2.26 −7.33 −3.33 −4.09 −7.83 −2.21 −3.72 −6.77
LDL-C −1.09 2.73 1.20 0.12 0.05 −3.78 0.47 −0.90 0.86
CK 1.09 −0.18 0.64 −0.72 −1.60 −1.10 −1.25 −1.78 −4.75
LD 0.90 −3.13 −8.93 −0.86 −2.53 −8.09 0.26 2.43 2.96
T3 −5.53 −13.11 −1.42 0.24 −11.32 4.64 2.91 −8.38 5.07
T4 −4.22 −2.80 −2.13 −2.86 −2.90 −1.98 −1.21 −0.75 −0.50
TSH 0.98 3.96 15.3 0.87 −0.46 14.79 0.72 −0.77 14.29
Free T4 2.18 0.36 −2.86 1.93 2.45 1.29 1.23 1.63 1.62

Abbreviations: See Table 1, 2.

Table 5.
Stability of hematology and coagulation tests with three vacuum tubes on day 1 and day 3 (% change compared with day 0)
  BD Vacutainer
Sekisui INSEPACK
Green Cross Green Vac-Tube
Day 1 Day 3 Day 1 Day 3 Day 1 Day 3
WBC −0.37 −7.79 −0.93 28.57 −2.21 −8.67
RBC −0.66 0.00 −0.88 −0.22 0.22 0.22
Hb −0.99 −0.70 −0.35 −0.85 −0.42 −4.45
Hct 0.98 3.00 0.46 2.60 0.98 2.86
MCV 1.84 3.30 0.75 2.84 0.76 2.79
MCHC −1.91 −2.40 −0.76 −3.41 −1.37 −3.74
RDW 0.00 −0.63 0.00 −0.39 0.55 0.31
Neutrophil 0.49 −5.85 2.03 −3.44 1.02 −8.06
Lymphocyte −3.00 2.23 −3.88 0.49 −2.10 6.20
Monocyte 67.71 35.41 11.96 26.45 4.03 26.62
Eosinophil −5.13 2.56 −7.41 0.41 1.29 4.72
Basophil 22.50 55.00 −10.87 32.61 2.33 58.14
ESR 14.53 −17.44 12.82 −13.46 −2.80 −30.84
PT 0.15 4.62 3.71 10.01 5.47 13.09
aPTT 7.57 15.96 17.07 24.78 10.65 21.57

Abbreviations: See Table 1, 3.

TOOLS
Similar articles