Journal List > Lab Med Online > v.5(2) > 1057300

TOOLS
Lee, Cha, Lee, and Kim: A Comparison of the Performance of Soyagreentec Ampulab EDTA and Sodium Citrate Tubes with That of BD Vacutainer Tubes
Original Article

Laboratory Medicine Online 2015; 5(2): 92-100.

Published online: 1 April 2015

DOI: https://doi.org/10.3343/lmo.2015.5.2.92

A Comparison of the Performance of Soyagreentec Ampulab EDTA and Sodium Citrate Tubes with That of BD Vacutainer Tubes

Jun Hyung Lee, M.D.1, Young Joo Cha, M.D.1, Dong Soon Lee, M.D.2, Seon Young Kim, M.D.2

1Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

2Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea.

Corresponding author: Young Joo Cha. Department of Laboratory Medicine, Chung-Ang University College of Medicine, 102 Heukseok-ro, Dongjak-gu, Seoul 156-755, Korea. Tel: +82-2-6299-2720, Fax: +82-2-6298-8630, chayoung@cau.ac.kr

Received 24 July 2014       Revised 29 September 2014       Accepted 30 September 2014

© 2015, Laboratory Medicine Online

(open-access):

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

Because blood collection tube can affect the results of various laboratory tests, it is necessary before using a newly developed product to verify its performance stringently and objectively. We compared the performance of Ampulab EDTA and sodium citrate tubes (Soyagreentec, Korea) with that of Vacutainer tubes (BD, USA) in accordance with international guidelines.

Methods

This study was performed as a multicenter study of Chung-Ang University Hospital and Seoul National University Hospital to evaluate the performance of two different instrument platforms. We performed the precision test according to CLSI GP34-A, the accuracy test according to CLSI EP09-A2-IR, and the vacuum test according to CLSI H1-A5 as well as stability, and aseptic condition tests. We evaluated 3 lots of Ampulab tubes for their precision, accuracy, vacuum, and aseptic condition.

Results

In precision test, the total precision levels of Ampulab tubes in most measurands were desirable or allowable. The results of mean corpuscular hemoglobin concentration, platelet distribution width, basophil, and reticulocyte counts for Ampulab tubes showed imprecision beyond allowable limits, but were similar to those of Vacutainer tubes. In the accuracy test, the bias in most measurands, except for the mean platelet volume, was within allowable limits. In the stability test, Ampulab showed similar performance to Vacutainer. In tests of the vacuum and aseptic conditions, Ampulab fulfilled both requirements.

Conclusions

The performance of Ampulab EDTA and sodium citrate tubes was equivalent to that of Vacutainer tubes.

Keywords: Ampulab, Bias, Blood collection tube, CLSI GP34-A, Precision, Vacutainer

Figures and Tables

Fig. 1

Line and scatter plots of stability test. X axis means elapsed time and Y axis means the average of % biases compared with the result of first measurement (0 hr) of each tube. The dashed lines mean upper and lower limits of desirable bias. (A) whole blood count (WBC), (B) hemoglobin (Hb), (C) platelet (PLT), (D) reticulocyte, (E) hemoglobin A1c (HbA1c), (F) brain natriuretic peptide (BNP), (G) prothrombin time (PT), (H) activated partial thrombin time (aPTT).

lmo-5-92-g001
Table 1

Information about evaluation tubes and control tubes, and measurands

lmo-5-92-i001
Tube type Manufacturer and product Lot number Draw volume Measurands
K2EDTA 5.4mg Soyagreentec Ampulab 31030050, 31030055, 31030058 3 mL WBC, RBC, Hb, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, PDW, PCT, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil, Reticulocyte, HbA1c, BNP
BD Vacutainer 2306179, 3032042
Sodium citrate 0.109 M, 3.2% Soyagreentec Ampulab 21050032, 21050034, 21050037 2.7 mL PT, aPTT
BD Vacutainer 3162249, 3189388

Abbreviations: WBC, white blood cell; RBC, red blood cell; Hb, hemoglobin; HCT, hematocrit; MCV, mean corpuscular volume; MCH, mean corpuscular hemoglobin; MCHC, mean corpuscular hemoglobin concentration; RDW, red cell distribution width; PLT, platelet; MPV, mean platelet volume; PDW, platelet distribution width; PCT, platelet crit; HbA1c, hemoglobin A1c; BNP, brain natriuretic peptide; PT, prothrombin time; aPTT, activated partial thromboplastin time.

Table 2

Summary of evaluation methods

lmo-5-92-i002
Category Protocol No. of lots No. of instruments No. of replicates
Precision CLSI GP34-A 3 Lot 2 instruments 3
Accuracy CLSI EP09-A2-IR 3 Lot 2 instruments 2*
Vacuum CLSI H1-A5 3 Lot 1 instrument 1
Stability (in-house) 1 Lot 1 instrument 1
Aseptic condition (in-house) 3 Lot 1 instrument 1

*Accuracy evaluation was performed using first and second results of 3 replicates.

Table 3

Precision of Ampulab and BD tubes; the desirable precisions, measured total precisions of Ampulab and Vacutainer tubes, and decisions

lmo-5-92-i003
Tube Measurand Desirable precision (%)† Instrument A* Instrument B*
Ampulab Vacutainer Ampulab Vacutainer
Measured precision (%)‡ Decision§ Measured precision (%)‡ Decision§ Measured precision (%)‡ Decision§ Measured precision (%)‡ Decision§
EDTA WBC 5.70 2.39 Desirable 2.20 Desirable 2.72 Desirable 2.81 Desirable
RBC 1.60 0.69 Desirable 0.64 Desirable 1.30 Desirable 1.35 Desirable
Hb 1.43 0.69 Desirable 0.62 Desirable 1.05 Desirable 1.11 Desirable
HCT 1.35 0.70 Desirable 0.66 Desirable 1.33 Desirable 1.55 Allowable
MCV 0.70 0.27 Desirable 0.22 Desirable 0.65 Desirable 0.58 Desirable
MCH 0.70 0.65 Desirable 0.65 Desirable 0.95 Allowable 0.81 Allowable
MCHC 0.53 0.76 Allowable 0.68 Allowable 1.06 Not Allowable 1.08 Not Allowable
RDW 1.75 0.54 Desirable 0.61 Desirable 0.68 Desirable 0.57 Desirable
PLT 4.55 2.03 Desirable 1.98 Desirable 3.06 Desirable 3.23 Desirable
MPV 2.15 1.16 Desirable 1.15 Desirable 3.13 Allowable 2.57 Allowable
PDW 1.40 3.41 Not Allowable 3.53 Not Allowable 5.55 Not Allowable 5.45 Not Allowable
PCT 5.95 2.66 Desirable 2.51 Desirable 3.97 Desirable 3.51 Desirable
Neutrophil 8.55 1.29 Desirable 1.35 Desirable 1.40 Desirable 1.30 Desirable
Lymphocyte 5.10 2.48 Desirable 2.30 Desirable 2.23 Desirable 2.42 Desirable
Monocyte 8.90 10.77 Allowable 10.27 Allowable 8.55 Desirable 8.44 Desirable
Eosinophil 10.50 10.19 Desirable 10.89 Allowable 9.14 Desirable 8.82 Desirable
Basophil 14.00 33.04 Not Allowable 31.72 Not Allowable 43.12 Not Allowable 36.40 Not Allowable
Reticulocyte 5.50 6.80 Allowable 5.53 Allowable 9.91 Not Allowable 10.36 Not Allowable
HbA1c 0.95 1.03 Allowable 0.78 Desirable 1.06 Allowable 1.74 Not Allowable
Sodium Citrate PT 2.00 1.33 Desirable 1.21 Desirable 1.47 Desirable 1.05 Desirable
aPTT 1.35 1.28 Desirable 1.20 Desirable 2.01 Allowable 1.63 Allowable

*Instrument A includes XE-2100, Variant II Turbo, CA-7000; Instrument B includes ADVIA 2120i, Integra 800, STA compact; †Desirable precision is based on Westgard's biological database; ‡Measured precision means measured total precision of 3 lots of Ampulab tubes or 2 lots of Vacutainer tubes; §'Desirable' means measured total precision ≤desirable precision; 'Allowable' means measured total precision ≤95% confidential interval of desirable; precision; 'Not Allowable' means measured total precision >95% confidential interval of desirable precision.

Table 4

Accuracy of Ampulab tubes; desirable bias and measured bias of Ampulab tubes compared with Vacutainer tubes

lmo-5-92-i004
Tube Measurand (unit) Decision level Decision conc. Desirable bias† Instrument A* Intrument B*
R§ Measured bias (95% CI) Decision∥ R Measured bias (95% CI) Decision∥
EDTA WBC Low 3 0.18 0.995 0.03 (-0.18, 0.24) Desirable 0.991 0.04 (-0.19, 0.27) Desirable
High 9 0.54 -0.01 (-0.13, 0.11) Desirable -0.29 (-0.47, -0.10) Desirable
RBC Low 3.7 0.07 0.995 -0.03 (-0.10, 0.04) Desirable 0.990 0.02 (-0.09, 0.13) Desirable
(×106/µL) High 5.6 0.10 0.01 (-0.03, 0.04) Desirable 0.04 (-0.01, 0.09) Desirable
Hb (g/dL) Low 11 0.20 0.999 -0.05 (-0.14, 0.05) Desirable 0.995 0.04 (-0.20, 0.28) Desirable
High 17 0.31 0.05 (0.00, 0.10) Desirable 0.03 (-0.05, 0.11) Desirable
HCT (%) Low 34 0.59 0.997 -0.41 (-0.81, -0.01) Desirable 0.986 -0.51 (-1.70, 0.67) Desirable
High 50 0.87 -0.27 (-0.52, -0.03) Desirable -0.30 (-0.68, 0.07) Desirable
MCV (fL) Low 84 1.06 0.997 0.02 (-1.40, 1.43) Desirable 0.993 -0.75 (-1.05, -0.45) Desirable
High 99 1.25 0.14 (-1.80, 2.09) Desirable -0.73 (-0.95, -0.51) Desirable
MCH (pg) Low 27 0.36 0.997 0.03 (-0.13, 0.20) Desirable 0.974 0.03 (-0.43, 0.48) Desirable
High 34 0.46 0.06 (-0.12, 0.24) Desirable -0.25 (-0.60, 0.11) Desirable
MCHC (g/dL) Low 31 0.12 0.983 0.06 (-0.11, 0.24) Desirable 0.812 0.56 (-0.25, 1.38) Allowable
High 35 0.14 -0.17 (-0.24, -0.10) Allowable 0.22 (-0.31, 0.74) Allowable
RDW (%) Low 10 0.17 0.999 -0.04 (-0.13, 0.05) Desirable 0.984 -0.02 (-0.24, 0.21) Desirable
High 14 0.23 -0.13 (-0.17, -0.09) Desirable -0.21 (-0.33, -0.09) Desirable
PLT (×103/µL) Low 140 8.30 0.996 6.10 (-0.10, 12.20) Desirable 0.995 2.51 (-0.51, 5.53) Desirable
High 400 23.72 -6.80 (-13.67, 0.00) Desirable 19.82 (15.24, 24.40) Desirable
MPV (fL) Low 8 0.18 0.987 0.23 (0.02, 0.44) Allowable 0.967 -0.42 (-0.52, -0.31) Not Allowable
High 12 0.28 -0.25 (-0.36, -0.13) Desirable -0.37 (-0.57, -0.16) Allowable
PDW (fL) Low 9 0.06 0.955 0.37 (-0.28, 1.03) Allowable 0.896 2.82 (-8.06, 13.69) Allowable
High 15 0.11 -0.24 (-0.62, 0.14) Allowable 2.28 (-7.26, 11.83) Allowable
PCT (%) Low 0.16 0.00 0.987 0.01 (0.00, 0.02) Allowable 0.987 0.06 (-0.04, 0.02) Allowable
High 0.33 0.01 -0.01 (-0.01, 0.00) Desirable -0.05 (-0.01, 0.00) Allowable
Neutrophil (%) Low 40 3.70 0.996 -0.14 (-1.05, 0.77) Desirable 0.993 -0.78 (-1.85, 0.30) Desirable
High 70 6.47 0.04 (-0.62, 0.71) Desirable -0.23 (-1.23, 0.77) Desirable
Lymphocyte (%) Low 22 2.02 0.996 -0.16 (-1.63, 1.31) Desirable 0.99 0.22 (-0.76, 1.19) Desirable
High 48 4.41 1.00 (0.96, 1.05) Desirable 1.15 (0.01, 2.28) Desirable
Monocyte (%) Low 3 0.40 0.996 -0.32 (-0.88, 0.24) Desirable 0.946 0.30 (-0.02, 0.61) Desirable
High 9 1.19 -0.65 (-0.01, 1.31) Desirable -0.64 (-1.23, -0.04) Desirable
Eosinophil (%) Low 0 0.00 0.995 0.06 (-0.11, 0.23) Allowable 0.994 0.09 (-0.10, 0.29) Allowable
High 7 1.39 0.03 (-0.21, 0.27) Desirable -0.01 (-0.27, 0.26) Desirable
Basophil (%) Low 0 0.00 0.909 0.30 (-0.50, 0.76) Allowable 0.907 -0.02 (-0.06, 0.03) Allowable
High 2 0.31 0.98 (-1.67, 2.43) Allowable -0.05 (-0.24, 0.16) Desirable
Reticulocyte (%) Low 0.4 0.03 0.976 -0.05 (-0.18, 0.09) Allowable 0.866 0.01 (-0.11, 0.13) Desirable
High 1.9 0.15 0.08 (0.02, 0.15) Desirable 0.09 (-0.26, 0.44) Desirable
HbA1c (%) Low 4.3 0.06 0.996 -0.01 (-0.06, 0.04) Desirable 0.998 0 (-0.05, 0.05) Desirable
High 6.1 0.09 -0.02 (-0.06, 0.02) Desirable -0.01 (-0.03, 0.01) Desirable
BNP Low 0 0.00 0.994 -5.72 (-18.56, 7.12) Allowable
(pg/mL) High 100 4.70 10.32 (0.35, 20.29) Allowable
Sodium Citrate PT (sec) Low 10.4 0.21 0.965 -0.01 (-0.08, 0.07) Desirable 0.939 -0.02 (-0.26, 0.23) Desirable
High 12.5 0.25 -0.1 (-0.32, 0.13) Desirable 0.06 (0, 0.11) Desirable
aPTT (sec) Low 26 0.59 0.985 0.74 (0.19, 1.29) Allowable 0.973 0.15 (-0.97, 1.28) Desirable
High 41 0.92 0.27 (-0.5, 1.05) Desirable 1.18 (0.59, 1.77) Allowable

*Instrument A includes XE-2100, Variant II Turbo, CA-7000; Instrument B includes ADVIA 2120i, Integra 800, STA compact; †Desirable bias is based on Westgard's biological database and presented absolute value; §R means correlation coefficient between the results of Ampulab tubes and the results of Vacutainer tubes; ∥'Desirable' means the estimated bias is within the desirable bias at each decision point; 'Allowable' means 95% confidential interval of the estimated bias overlaps with the desirable bias; 'Not Allowable' means 95% confidential interval of the estimated bias pass over the desirable bias; BNP, exceptionally presented in this table, was measured by ADVIA Centaur XP as EDTA plasma test.

Table 5

Stability of Ampulab and Vacutainer tubes on 1st, 2nd, 3rd, 4th measurements (% change compared with 0 hr)

lmo-5-92-i005
Tube Instrument Measurand Desirable bias (%) Ampulab Vacutainer
0 hr 6 hr 24 hr 72 hr 0 hr 6 hr 24 hr 72 hr
EDTA XE-2100 WBC 5.70 0.00 1.69 2.57 0.99 0.00 0.39 1.21 0.90
RBC 1.60 0.00 -0.31 -0.57 0.33 0.00 0.13 -0.06 0.17
Hb 1.43 0.00 -0.47 -0.17 0.73 0.00 -0.37 0.00 0.90
HCT 1.35 0.00 -0.09 0.35 2.11* 0.00 0.16 0.63 1.87*
MCV 0.70 0.00 0.23 0.90* 1.78* 0.00 0.05 0.70 1.70*
MCH 0.70 0.00 -0.15 0.41 0.46 0.00 -0.46 0.12 0.76*
MCHC 0.53 0.00 -0.36 -0.48 -1.34* 0.00 -0.59* -0.61* -0.94*
RDW 1.75 0.00 -0.11 -0.19 -0.34 0.00 -0.45 -0.27 -0.19
PLT 4.55 0.00 0.69 1.66 2.31 0.00 0.02 2.14 1.87
MPV 2.15 0.00 0.66 2.92* 6.60* 0.00 1.27 4.00* 8.48*
PDW 1.40 0.00 -0.50 2.58* 7.83* 0.00 0.38 4.28* 9.94*
PCT 5.95 0.00 1.47 4.95 9.36* 0.00 1.47 6.80* 10.85*
Neutrophil 8.55 0.00 -0.44 -0.81 0.08 0.00 -0.14 -0.39 -0.01
Lymphocyte 5.10 0.00 -1.51 0.56 -0.76 0.00 -1.53 -0.27 -1.17
Monocyte 8.90 0.00 12.68* 5.36 4.91 0.00 9.81* 4.86 6.42
Eosinophil 10.50 0.00 -0.93 -2.80 -3.74 0.00 0.58 1.75 1.55
Basophil 14.00 0.00 21.88* 20.31* 9.37 0.00 1.49 -2.99 -5.97
Reticulocyte 5.50 0.00 -1.16 1.92 2.61 0.00 -0.52 2.03 1.90
Variant II turbo 0 Day 1 Day 3 Day 7 Day 0 Day 1 Day 3 Day 7 Day
HbA1c 1.50 0.00 0.09 -1.23 0.00 0.00 -0.28 0.38 -1.14
ADVIA Centaur 0 Day 1 Day 3 Day 7 Day 0 Day 1 Day 3 Day 7 Day
BNP 4.70 0.00 -8.95* -8.76* -18.97* 0.00 -9.17* -10.23* -21.36*
Sodium Citrate 0 hr 6 hr 12 hr 24 hr 0 hr 6 hr 12 hr 24 hr
CA-7000 PT 2.00 0.00 2.36* 0.42 9.30* 0.00 2.85* -0.64 6.84*
aPTT 1.35 0.00 0.01 3.25* 7.46* 0.00 1.23 2.91* 5.64*

*The measured bias is beyond the desirable bias of biological variation.

Notes

This article is available from http://www.labmedonline.org

References

1. Oh SH, Kim CS. [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; 27:69–75.
crossref
2. Won EJ, Shin MG, Jang MJ, Cho D, Kee SJ, Kim SH, et al. Comparison between V-Tubes and BD Vacutainer Tubes for Use in Laboratory Tests. Lab Med Online. 2013; 3:145–154.
crossref
3. CLSI. Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline. CLSI document GP34-A. Wayne, PA: Clinical and Laboratory Standards Institute;2010.
4. Ricós C, Alvarez V, Cava F, García-Lario JV, Hernández A, Jiménez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest. 1999; 59:491–500.
crossref
5. Westgard JO. Desirable Specifications for Total Error, Imprecision, and Bias, derived from intra- and inter-individual biologic variation. Updated on 22 Jun 2014. http://www.westgard.com/biodatabase1.htm.
6. CLSI. Method Comparison and Bias Estimation Using Patient Samples Approved Guideline-Second Edition (Interim Revision). CLSI document EP09-A2-IR. Wayne, PA: Clinical and Laboratory Standards Institute;2010.
7. CLSI. Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Fifth Edition. CLSI document H1-A5. Wayne, PA: Clinical and Laboratory Standards Institute;2003.
8. Bowen RA, Chan Y, Ruddel ME, Hortin GL, Csako G, Demosky SJ Jr, et al. Immunoassay interference by a commonly used blood collection tube additive, the organosilicone surfactant silwet L-720. Clin Chem. 2005; 51:1874–1882.
crossref
9. Bowen RA, Hortin GL, Csako G, Otañez OH, Remaley AT. Impact of blood collection devices on clinical chemistry assays. Clin Biochem. 2010; 43:4–25.
crossref
10. Bowen RA, Vu C, Remaley AT, Hortin GL, Csako G. Differential effect of blood collection tubes on total free fatty acids (FFA) and total triiodothyronine (TT3) concentration: a model for studying interference from tube constituents. Clin Chim Acta. 2007; 378:181–193.
crossref
11. Bush VJ, Janu MR, Bathur F, Wells A, Dasgupta A. Comparison of BD Vacutainer SST Plus Tubes with BD SST II Plus Tubes for common analytes. Clin Chim Acta. 2001; 306:139–143.
crossref
12. Li Z, Feng Z, Yan C, Yan R. Evaluation of BD Vacutainer SST™ II Plus tubes for common tumor marker tests by Roche Diagnostics Modular E 170 analyzer. J Clin Lab Anal. 2010; 24:418–421.
crossref
13. CLSI. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline. CLSI Document H21-A5. 5th ed. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute;2008.
14. Versalovic J. American Society for Microbiology. Manual of clinical microbiology. 10th ed. Washington, DC: ASM Press;2011. p. 286–301.
TOOLS
Similar articles