®
A Comparison of BD Microtainer MAP Microtube ® for Automated Process with the BD Microtainer Tube with Microgard™ Closure for Routine Hematology Testing ® on the Beckman Coulter LH 750 Over Time
VS8114-WHITE PAPER
A Comparison of BD Microtainer® MAP Microtube for Automated Process with the BD Microtainer® Tube with Microgard™ Closure for Routine Hematology Testing on the Beckman Coulter® LH 750 Over Time
ABSTRACT ®
Two studies were performed to compare BD Microtainer MAP Microtube for Automated Process ® ® (BD MAP) with the BD Microtainer Tube with Microgard™ closure (BD Microtainer Tube) for ® routine hematology testing on the Beckman Coulter LH 750 analyzer. Specimens were collected via finger puncture from 100 subjects (50 apparently healthy adult subjects on-site and 50 adult subjects off-site from inpatient and outpatient populations). Testing was performed on specimens from both ® tubes for a complete blood count, including platelets and reticulocytes, on the Beckman Coulter LH 750 hematology analyzer at initial time and for BD MAP over time at 12 hours from time of collection. Based on the data collected, BD MAP demonstrated clinically acceptable performance for ® all hematology parameters measured on the Beckman Coulter LH 750 analyzer as compared to ® BD Microtainer Tubes with Microgard™ closure when tested at initial time (within four hours from time of collection). BD MAP demonstrated stability over time for all hematology parameters at 12 hours from time of collection as compared to initial time.
INTRODUCTION BD has developed an innovative blood collection tube intended for collecting low volumes of capillary ® blood. BD Microtainer MAP Microtube for Automated Process (BD MAP) is intended for the collection, anticoagulation, transport and storage of skin puncture blood specimens for routine hematology testing on automated hematology systems, and is targeted for geriatric, oncology, pediatric, NICU and ICU patients, as well as the general population. BD MAP is a non-evacuated, 13x75 mm polypropylene tube with an HDPE cap and a penetrable septum, which is designed to minimize the amount of wasted blood volume when the tube is analyzed in an inverted position (i.e., for automated hematology systems). In addition, the interior walls of the tube are spray coated with ® K2EDTA anticoagulant. This study evaluated the performance of BD Microtainer MAP Microtube for ® Automated Process as compared to the BD Microtainer Tube with Microgard™ closure for routine ® hematology testing on the Beckman Coulter LH 750 analyzer.
OBJECTIVES ®
®
To compare BD Microtainer MAP Microtube for Automated Process with the BD Microtainer Tube ® with Microgard™ closure for routine hematology testing on the Beckman Coulter LH 750 hematology analyzer at initial time. ®
To evaluate stability of BD Microtainer MAP Microtube for Automated Process over time at 12 hours from time of blood collection.
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METHODS AND MATERIALS Blood was collected from 100 adult subjects, 18 years of age or older, 50 off-site from inpatient and outpatient facilities (Study 1), as well as 50 on-site at BD (Study 2). For Study 1, each subject received ® two separate finger punctures using a BD Microtainer Contact-Activated Lancet in order to collect blood into one evaluation and one control tube according to a randomization schedule (Table 1). Immediately after blood collection, the tubes were capped and mixed by 8-10 complete inversions. Specimens were allowed to sit for a minimum of 30 minutes from time of collection at room temperature prior to testing. Testing was then performed on specimens from the control and evaluation tubes for a complete blood count, including platelets and reticulocytes, on the Beckman ® Coulter LH 750 hematology analyzer (see Table 2) at initial time (within 4 hours from time of collection). For Study 2, each subject received three separate finger punctures using a BD ContactActivated Lancet in order to collect blood into two evaluation tubes and one control tube according to a randomization schedule. The specimens were handled the same as in Study 1, however, the second ® evaluation tube was tested on the Beckman Coulter LH 750 hematology analyzer at 12 hours from time of blood collection.
Table 1. Study Tubes Control/Evaluation Control Evaluation Evaluation
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Tube Type BD Microtainer® Tube with Microgard™ Closure BD Microtainer® MAP Microtube for Automated Process BD Microtainer® MAP Microtube for Automated Process
Fill Volume (mL)
Additive
Time Interval
0.5
K2EDTA
Initial Time
0.5
K2EDTA
Initial Time
0.5
K2EDTA
12 hours
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Table 2. Parameters and Analyzers Analyzer
Measured Parameters
Abbreviation
Red Blood Cells White Blood Cells Hemoglobin Hematocrit Platelets % Reticulocytes
RBC WBC HGB HCT PLT RET %
Calculated Indices ®
Beckman Coulter LH 750
Mean Corpuscular Volume Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration
MCV MCH MCHC
Automated WBC Differential % Neutrophils % Lymphocytes % Eosinophils % Monocytes % Basophils
NE % LY % EO % MO % BA %
DATA ANALYSIS A total of 50 subjects participated in each study. Data were to be combined from the two studies for a total of 100 subjects. Statistical analysis of the variances for all parameters was evaluated between studies and only three parameters; platelets, MCHC and % neutrophils, were able to be combined. In addition, platelet results were excluded due to platelet flag errors (i.e. platelet clumps, giant platelets, ® etc.) - a total of 10 in BD MAP tube and 10 in the BD Microtainer Tube. One additional reticulocyte result was missing due to an instrument error. The overall impact of the missing data was not statistically significant. There were a total of 85 pairs of data available for equivalence determination between the evaluation tube and control tube and 38 pairs of data for stability comparison for 12 hours versus initial time in Study 2. Analysis of variance (ANOVA) procedures, followed by a predetermined set of multiple comparisons, were used to analyze the data for each parameter. Mean tube biases and 95% confidence limits (corresponding to 95% equivalence tests) for the various between–tube comparisons were calculated. ® A Deming regression was also performed for each parameter to obtain BD MAP vs BD Microtainer Tube mean bias (with two one-sided 95% confidence limits) at the average of the control tube and at predetermined medical decision levels.
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RESULTS AND DISCUSSIONS ®
Results for BD MAP were compared to results for BD Microtainer Tube when tested at initial time (within four hours from time of collection). Also shown for each parameter is a predetermined clinical acceptance limit (CAL), which represents an estimate of the maximum allowable difference or change in test results on average. CALs are used by BD to help identify differences which may be considered clinically significant. These values may reflect the opinion of investigators from BD-sponsored clinical trials and, therefore, may not be constant from one study to another. The laboratory should evaluate the data presented and make its own determination concerning the acceptability of results. If the mean bias and 95% limits were within the CAL, then the results met the requirement for equivalence. Instances where the mean bias was within the CAL but the 95% limit(s) extended beyond the CAL are bolded and italicized. Instances where the mean bias exceeded the CAL are shaded. If clinical acceptance limits were not established, results were evaluated for statistical differences. Statistical differences are marked with an asterisk. Medical decision points were defined for five parameters: WBC, PLT, HGB, HCT and MCV. ® BD MAP demonstrated equivalence to the BD Microtainer Tube for all parameters measured at all 3 applicable medically relevant points with the exception of WBC at the lower MDP of 3.0 x 10 /µL, where the average systematic bias exceeded the CAL of 7% at -10.78%. 3
For WBC, a percent CAL was determined to be inappropriate for values below 4.0 x 10 /µL; therefore, the data for WBC were split and a unit CAL of ±0.3 applied. When the data were split, the WBC 3 subset ≤ 4.0 x 10 /µL was able to be combined with the data generated on-site at BD, resulting in a 3 sample size of nine subjects. WBC data > 4.0 x 10 /µL still demonstrated differences in variance and were analyzed separately. 3
For WBC ≤ 4.0 x 10 /µL, the average bias is within the unit CAL; however, the confidence interval 3 extends beyond the limits, while WBC results > 4.0 x 10 /µL demonstrated clinical equivalence. For reticulocytes, there were no clinical acceptance criteria defined; results were evaluated for statistical differences. There were no statistically significant differences observed. In Study 1, systematic biases were not determined for platelets, hemoglobin and hematocrit at the 3 upper medical decision points of 600 x 10 /µL, 17.0 g/dL and 55%, respectively, because actual data were not obtained at or near those points. In Study 2, systematic biases were also not determined for hemoglobin at the lower medical decision point of 10.0 g/dL and platelets at the upper medical 3 decision point of 600 x 10 /µL for the same reason above.
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Table 3. Summary Results: Study 1 t0 Parameter
Tube Type
n
Mean
SD
Range obtained (min – max)
RBC (106/μL)
BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube BD MAP BD Microtainer® Tube
50 50 50 50 48 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 49 49
3.60 3.59 11.86 11.72 213.42 216.52 10.96 10.96 32.12 32.04 89.48 89.36 30.50 30.55 34.07 34.15 67.64 67.47 22.58 22.31 7.38 7.57 1.82 2.08 0.59 0.57 1.81 1.81
0.59 0.58 11.16 10.85 95.20 96.36 1.96 1.97 5.55 5.44 7.10 7.04 2.71 2.72 0.73 0.78 17.56 17.47 16.16 16.32 3.43 3.27 1.93 3.38 0.54 0.52 1.19 1.17
2.41 – 4.97 2.44 – 4.91 0.2 – 74.4 0.4 – 71.4 10 – 445 10 – 473 7.5 – 14.5 7.5 – 14.5 22.9 – 42.3 22.9 – 41.6 65.8 – 106.0 65.6 – 105.5 21.7 – 35.3 21.8 – 35.0 32.0 – 35.3 32.1 – 35.7 6.8 – 92.9 6.6 – 92.2 4.3 – 87.3 3.3 – 87.9 0.8 – 17.0 1.9 – 18.2 0 – 11.7 0 – 23.7 0 – 2.8 0 – 2.1 0.05 – 6.74 0.01 – 6.52
WBC (103/μL) PLT (103/μL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) NE (%) LY (%) MO (%) EO (%) BA (%) RET (%)
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Table 4. Summary Results: Study 2 Initial time and 12 hours (t0 and t12) Parameter RBC (106/μL) WBC (103/μL) PLT (103/μL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) NE (%) LY (%) MO (%) EO (%) BA (%) RET (%) 6
Tube Type
n
Mean
SD
Range obtained (min – max)
BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0) BD MAP (t0) BD MAP (t12) BD Microtainer® Tube (t0)
50 49 48 50 49 48 42 42 38 50 49 48 50 49 48 50 49 48 50 49 48 50 49 48 50 49 48 50 49 48 50 49 48 50 49 48 50 49 48 49 49 48
4.50 4.50 4.55 6.31 6.42 6.53 221.38 220.50 229.76 13.87 13.83 14.01 40.38 40.69 40.81 89.92 90.66 90.03 30.91 30.84 30.90 34.35 33.99 34.30 59.55 60.79 59.69 28.75 28.67 28.64 7.74 7.19 7.72 2.67 2.70 2.76 1.30 0.64 1.19 1.17 1.08 1.16
0.47 0.48 0.50 1.66 1.66 1.69 56.64 50.98 54.41 1.24 1.24 1.45 3.54 3.66 4.02 5.25 5.45 5.45 2.13 2.10 2.20 0.67 0.65 0.63 7.48 7.64 7.72 6.05 6.15 6.22 2.01 1.90 2.04 2.06 2.11 2.07 0.97 0.58 0.69 0.48 0.41 0.50
3.60 – 5.57 3.70 – 5.60 3.65 – 5.52 3.3 – 10.2 3.5 – 11.7 3.6 – 11.2 119 – 375 126 – 384 120 – 373 11.3 – 16.7 11.7 – 17.0 11.3 – 18.4 32.9 – 49.6 34.2 – 50.9 33.2 – 53.6 67.3 – 98.0 68.1 – 98.8 67.1 – 98.3 21.5 – 34.3 21.6 – 34.0 21.6 – 34.3 31.9 – 35.5 31.7 – 35.0 32.3 – 35.5 38 – 72 36.9 – 72.6 37.5 – 72.5 16.9 – 45.7 17.0 – 44.5 17.3 – 45.3 4.5 – 15.4 3.3 – 13.0 4.5 – 15.1 0.5 – 10.0 0.3 – 11.2 0.7 – 10.5 0.3 – 5.9 0.1 – 3.3 0.2 – 2.9 0.36 – 2.32 0.38 – 2.25 0.44 – 2.31 VS8114-WP
Table 5. Bias and Confidence Intervals BD MAP vs BD Microtainer® Tube (Study 1) Parameter
Clinical Criteria
BD MAP vs. BD Microtainer® Tube
RBC WBC (all data) WBC (> 4.0 x 103/µL) HGB HCT MCV MCH LY MO EO BA RET
±4% ±7% ±7% ±3% ±5% ±4% ±5% ±5% ±5% ±5% ±5% None established
0.0% (-0.5%, 0.6%) -1.0% (-4.0%, 2.1%) 1.3% (-0.7%, 3.4%) -0.1% (-0.6%, 0.5%) 0.08% (-0.12%, 0.27%) 0.1% (0.0%, 0.3%) -0.2% (-0.4%, 0.0%) 0.26% (-0.06%, 0.58%) -0.19% (-0.58%, 0.21%) -0.26% (-0.67%, 0.14%) 0.02% (-0.07%, 0.11%) 3.0% (-6.5%, 13.4%)
Table 6. Bias and Confidence Intervals BD MAP vs BD Microtainer®Combined Data (Study 1 and 2) Parameter
Clinical Criteria
BD MAP vs. BD Microtainer® Tube
WBC (≤ 4.0 x 103/μL) PLT MCHC NE
±0.3 ±10% ±5% ±5%
-0.29 x 103/µL (-0.51, -0.07) -2.9% (-4.3%, -1.5%) -0.1% (-0.3%, 0.1%) 0.04% (-0.17%, -0.26%)
Systematic biases within the CAL with an interval overlapping the CAL are bolded and italicized.
Table 7. Bias and Confidence Intervals BD MAP vs BD Microtainer® Tube (Study 2) Parameter
Clinical Criteria
BD MAP vs. BD Microtainer® Tube
RBC WBC (all data) WBC (>4.0 x 103/µL) HGB HCT MCV MCH LY MO EO BA RET
±4% ±7% ±7% ±3% ±5% ±4% ±5% ±5% ±5% ±5% ±5% None established
-0.7% (-1.6%, 0.3%) -3.4% (-4.9%, -1.8%) -3.0% (-4.4%, -1.5%) -0.7% (-1.7%, 0.3%) -0.33% (-0.78%, 0.12%) -0.1% (-0.2%, 0.0%) 0.0% (-0.3%, 0.3%) 0.05% (-0.17%, 0.26%) 0.09% (-0.08%, 0.26%) -0.04% (-0.11%, 0.02%) 0.00% (-0.17%, 0.16%) -0.001% (-0.057%, 0.056%)
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Table 8. Systematic Biases at Medically Relevant Points BD MAP vs. BD Microtainer® Tube (Study 1) Parameter
CAL
RBC†
±4%
WBC (> 4.0 x 103/μL)†
±7%
WBC† (all data)
±7%
HGB†
±3%
HCT
±5%
MCV†
±4%
MCH† LY MO EO BA
±5% ±5% ±5% ±5% ±5% None established
RET
Medically Relevant Points
Source+
Systematic Bias (Two One-Sided 95% Confidence Limits)
3.6 12.76 12 3 11.7 12 10 11.0 17 30 32.0 55 80 89.4 100 30.6 22.3 7.6 2.1 0.6
AV AV MDP MDP AV MDP MDP AV MDP MDP AV MDP MDP AV MDP AV AV AV AV AV
0.05% (-0.52, 0.62) 1.35% (-0.41, 3.14) 1.34% (-0.5, 3.21) -10.78% (-22.93, 3.28) 1.57% (-1.13, 4.34) 1.8% (-1.03, 4.71) -0.04% (-0.55, 0.47) -0.05% (-0.67, 0.57) N/A 0.04% (-0.13, 0.2) 0.08% (-0.12, 0.28) N/A 0.09% (-0.15, 0.32) 0.13% (-0.04, 0.31) 0.18% (-0.11, 0.48) -0.18% (-0.4, 0.03) 0.26% (-0.06, 0.58) -0.19% (-0.6, 0.23) -0.26% (-0.68, 0.15) 0.02% (-0.08, 0.12)
1.8
AV
-0.007% (-0.144, 0.13)‡
†Unweighted log deming regression performed. ‡No CAL, so limits reported for systematic biases are the 95% confidence interval instead of the two one-sided 95% confidence limits. +Source abbreviations: AV – Average Value of the control tube, MDP – Medical Decision Point Systematic biases falling outside the CAL are shaded. N/A – Not Applicable
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Table 9. Systematic Biases at Medically Relevant Points BD MAP vs. BD Microtainer® Tube for Combined Data (Study 1 and 2) Parameter
CAL
Medically Relevant Points
Source+
Systematic Bias (Two One-Sided 95% Confidence Limits)
WBC (≤ 4.0 x 103/μL)† PLT
0.3 10%
MCHC NE
5% 5%
3.0 50 222.2 600 34.2 63.7
MDP, AV MDP AV MDP AV AV
-0.29 x 103/µL (-0.51, -0.06) -0.25% (-4.14, 3.8) -3.08% (-4.48, -1.66) N/A -0.09% (-0.29, 0.12) 0.04% (-0.18, 0.26)
Systematic biases within the CAL with an interval overlapping the CAL are bolded and italicized.
Table 10. Systematic Biases at Medically Relevant Points BD MAP vs. BD Microtainer® Tube (Study 2) Parameter
CAL
Medically Relevant Points
Source+
Systematic Bias (Two One-Sided 95% Confidence Limits)
RBC†
±4%
4.55
AV
-0.7% (-1.66, 0.27)
3
MDP
-6.74% (-12.53, -0.57)
WBC† (all data)
±7%
6.5
AV
-3.23% (-4.79, -1.64)
12
MDP
-0.39% (-5.55, 5.05)
6.76
AV
-2.93% (-4.49, -1.34)
12
MDP
-1.74% (-6.67, 3.46)
10
MDP
N/A
14.0
AV
-0.8% (-1.86, 0.27)
17
MDP
-2.99% (-6.84, 1.01)
WBC (> 4.0 x 103/µL)†
HGB†
HCT
MCV†
7%
±3%
±5%
±4%
30
MDP
1.02% (-1.02, 3.06)
40.8
AV
-0.33% (-0.8, 0.13)
55
MDP
-2.11% (-5.78, 1.55)
80
MDP
0.12% (-0.06, 0.3)
90.0
AV
-0.07% (-0.18, 0.04)
100
MDP
-0.24% (-0.43, -0.05)
MCH†
±5%
30.9
AV
0.02% (-0.27, 0.3)
LY
±5%
28.6
AV
0.05% (-0.17, 0.27)
MO
±5%
7.7
AV
0.09% (-0.08, 0.26)
EO
±5%
2.8
AV
-0.04% (-0.11, 0.02)
BA
±5%
1.2
AV
0% (-0.18, 0.18)
RET
None established
1.2
AV
-0.001% (-0.058, 0.057)‡
†Unweighted log deming regression performed. ‡No CAL, so limits reported for systematic biases are the 95% confidence interval instead of the two one-sided 95% confidence limits. +Source abbreviations: AV – Average Value of the control tube, MDP – Medical Decision Point Systematic biases within the CAL with an interval overlapping the CAL are bolded and italicized. N/A – Not Applicable VS8114-WP
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Bias plots were reviewed for hemoglobin and hematocrit and one data point appeared to be an outlier for both, adversely affecting the overall results. An additional analysis was performed and this data point was determined to be an outlier following the criteria of EP9-A21. The data were re-analyzed without this data point and the results for systematic biases and confidence intervals were all well within the clinical acceptance criteria for both. Table 11. Systematic Bias for HGB and HCT (BD MAP vs. BD Microtainer® Tubes) Parameter
CAL
HGB†
3%
HCT
5%
Medically Relevant Points
Source+
Systematic Bias (Two One-Sided 95% Confidence Limits)
10 13.9 17 30 40.5 55
MDP AV MDP MDP AV MDP
N/A -0.21% (-0.7, 0.27) -0.73% (-1.92, 0.48) -0.13% (-0.53, 0.27) -0.08% (-0.24, 0.08) -0.01% (-0.71, 0.68)
†Unweighted log deming regression performed. N/A – not applicable. Source abbreviations: AV – Average Value of the control tube, MDP – Medical Decision Point
BD MAP Stability Over Time (12 hours vs Initial Time) Results were obtained after 12 hours from time of blood collection and compared with those obtained for BD MAP at initial time. Biases and 95% limits were calculated and compared to the acceptance criteria for each parameter. For reticulocytes, results were evaluated for statistically significant differences, since clinical acceptance criteria were not established.
Table 12. Stability Over Time in BD MAP Bias and 95% Confidence Limits (Study 2) Parameter
CAL
BD MAP 12 Hours vs. Initial Time
RBC WBC PLT HGB HCT MCV MCH MCHC NE LY MO EO BA RET
±4% ±7% ±10% ±3% ±5% ±4% ±5% ±5% ±5% ±5% ±5% ±5% ±5% None established
-0.1% (-0.6%, 0.5%) 0.9% (-0.7%, 2.5%) 0.5% (-1.4%, 2.5%) -0.2% (-0.7%, 0.4%) 0.34% (0.09, 0.58) 0.9% (0.7%, 1.1%) -0.1% (-0.4%, 0.1%) -1.0% (-1.4%, -0.7%) 1.26% (0.71, 1.80) -0.12% (-0.48, 0.25) -0.53% (-0.90, -0.15) 0.02% (-0.08, 0.13) -0.54% (-0.89, -0.39) -8.1% (-15.4, -0.2)*
Statistical differences are marked with an asterisk. 10
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All results were within acceptable limits, indicating clinical equivalence and stability over time, with the exception of reticulocytes. Reticulocytes demonstrated a statistically significant negative bias over time as compared to initial time at the 12-hour time interval. The average reticulocyte count was 1.17 at initial time and 1.08 at 12 hours. The change in results over time was determined to be clinically insignificant as it would not cause a change in patient diagnoses and/or treatment. Mean difference plots were recorded for individual subject differences and were plotted on the y-axis ® against the individual subject averages (BD MAP + BD Microtainer Tube)/2. Systematic biases at relevant points were also plotted along with two one-sided 95% confidence limits. Mean difference plots are provided in Appendix 1. Platelet Clumping Platelet clumping occurs in capillary blood due to the collection method itself. When the skin is punctured, circulating platelets adhere to the damaged tissue and are “activated”, causing platelet aggregation, the beginning of the clotting process. There were 23 incidences of platelet clumping observed during this study; 7 for BD MAP at initial ® time, 7 for BD MAP at 12 hours and 9 for BD Microtainer Tube at initial time. Platelet clumping was comparable across all tube types with no statistically significant difference between tube types (p-value = 0.17). The platelet clumping observed during this study was anticipated and the frequency observed per tube type comparable, indicating that it was most likely a function of the collection technique and not related to the tube type. Clotting Clotting was tabulated for each tube type. There were 7 incidences of clotting observed; 2 in the ® BD Microtainer Tube at initial time, 4 in BD MAP at initial time, and 1 in BD MAP after 12 hours. There were no statistically significant differences for clotting frequency between tube types.
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CONCLUSIONS ®
BD Microtainer MAP Microtube for Automated Process demonstrated clinically acceptable ® performance for all hematology parameters measured on the Beckman Coulter LH 750 analyzer as ® compared to the BD Microtainer Tube with Microgard™ closure. BD MAP demonstrated stability over time for up to 12 hours from time of collection when stored at room temperature.
Reference 1. Clinical Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition. CLSI (formerly NCCLS) document EP9-A2. Wayne, PA, 2002.
Whenever changing any manufacturer’s blood collection tube type, size, handling, processing or storage condition for a particular laboratory assay, the laboratory personnel should review the tube manufacturer’s data and their own data to establish/verify the reference range for a specific instrument/reagent system. Based on such information, the laboratory can then decide if a change is appropriate.
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APPENDIX 1. ®
Mean Difference Plots: BD MAP vs. BD Microtainer Tube ®
Beckman Coulter LH 750: Study 1: RBC
WBC
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
6% 40% 4% CAL
4%
20%
2%
Bias
Bias
7% CAL 0%
0% -7% CAL
-2%
-20% -4% CAL
-4%
-40% -6% 2.5
3.0
3.5
4.0
4.5
5.0
0
20
40
Mean (x10^6/µL)
60
Mean (x10^3/µL)
HGB
HCT
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
8%
5 CAL 4
6% 4%
2
3% CAL Bias (percent)
Bias
2% 0% -2% -3% CAL
0
-2
-4% -6%
-4 -5 CAL
-8% 8
10
12
14
25
30
Mean (g/dL)
35
40
Mean (percent)
MCV
MCH
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
4%
4% CAL
5% CAL 4%
2%
Bias
Bias
2%
0%
0%
-2% -2%
-4% -4%
-4% CAL 70
80
90 Mean (fL)
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100
-5% CAL 22
24
26
28
30
32
34
Mean (pg)
13
LY
MO
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
8 6
6
5 CAL
4
4
2
2
Bias (percent)
Bias (percent)
5 CAL
0 -2 -4
0 -2 -4
-5 CAL
-5 CAL
-6
-6
-8 20
40
60
80
5
Mean (percent)
10
15
Mean (percent)
EO
BA
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer 5 CAL
10
4
5 CAL
2 Bias (percent)
Bias (percent)
5
0
-5 CAL
-5
0
-2
-4
-10
-5 CAL 0
5
10
15
0.0
Mean (percent)
0.5
1.0
1.5
2.0
Mean (percent)
RETIC BD MAP vs. BD Microtainer
Bias (percent)
1
0
-1
0
2
4
6
Mean (percent)
14
VS8114-WP
Combined Data (Study 1 and Study 2):
PLT
MCHC
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer 5% CAL
30% 4% 20% 2% 10% CAL Bias
Bias
10%
0%
-10%
0%
-10% CAL -2%
-20% -4% -30%
-5% CAL 0
100
200
300
400
32
Mean (x10^3/µL)
33
34
35
Mean (g/dL)
NE BD MAP vs. BD Microtainer 6 5 CAL 4
Bias (percent)
2
0
-2
-4 -5 CAL -6 20
40
60
80
Mean (percent)
VS8114-WP
15
Study 2:
RBC
WBC
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
20%
20%
10%
10% 7% CAL Bias
Bias
4% CAL 0%
0%
-4% CAL -7% CAL -10%
-10%
-20%
-20% 4.0
4.5
5.0
5.5
4
6
Mean (x10^6/µL)
8
10
Mean (x10^3/µL)
HGB
(No Outlier) HGB
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
6%
20% 4% 3% CAL 2% 3% CAL Bias
Bias
10%
0%
0%
-3% CAL -2%
-10%
-3% CAL -4% -20% -6% 12
13
14
15
16
17
12
Mean (g/dL)
13
14
15
16
17
Mean (g/dL)
HCT
(No Outlier) HCT
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer 5 CAL
10
4
5 CAL
2 Bias (percent)
Bias (percent)
5
0
-5
-5 CAL
0
-2
-4
-10
-5 CAL 35
40 Mean (percent)
16
45
50
35
40
45
50
Mean (percent)
VS8114-WP
MCV
MCH
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer
4%
4% CAL
5% CAL 4%
2%
Bias
Bias
2%
0%
0%
-2% -2%
-4% -4%
-4% CAL 70
75
80
85
90
-5% CAL
95
22
24
26
Mean (fL)
28
30
32
34
Mean (pg)
LY
MO
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer 5 CAL 4
2
2 Bias (percent)
Bias (percent)
5 CAL 4
0
-2
0
-2
-4
-4 -5 CAL 20
25
30
35
40
-5 CAL
45
6
8
Mean (percent)
10
12
14
Mean (percent)
EO
BA
BD MAP vs. BD Microtainer
BD MAP vs. BD Microtainer 5 CAL 4
2
2 Bias (percent)
Bias (percent)
5 CAL 4
0
-2
0
-2
-4
-4 -5 CAL 2
4
6 Mean (percent)
VS8114-WP
8
10
-5 CAL 0.5
1.0
1.5
2.0
2.5
Mean (percent)
17
RETIC BD MAP vs. BD Microtainer
0.4
Bias (percent)
0.2
0.0
-0.2
-0.4
0.5
1.0
1.5
2.0
Mean (percent)
18
VS8114-WP
Stability (Bias with Confidence Limits - 12 hours vs Initial Time):
RBC
WBC Calculated SD = 0.0946
0.2
Calculated CV = 3.8%
1.5
1.0 0.1
Difference x10^6/µL
12hour
0.0
Bias Lines 12hour Zero
-0.1
0.5
12hour
Difference x10^3/µL 0.0
Bias Lines 12hour Zero
-0.5
-1.0 -0.2 -1.5 3.5
4.0
4.5
5.0
5.5
6.0
2
4
6
Mean x10^6/µL
8
10
12
Mean x10^3/µL
PLT
HGB Calculated CV = 4.1%
40
Calculated CV = 1.5%
0.6
0.4 20
Difference x10^3/µL
12hour
0
Bias Lines 12hour Zero
0.2
12hour
Difference g/dL
0.0
Bias Lines 12hour Zero
-0.2
-20 -0.4
-0.6
-40
100
150
200
250
300
350
400
11
12
13
14
15
Mean x10^3/µL
Mean g/dL
HCT
MCV Calculated SD = 0.9
2
1
1
Difference fL
12hour Bias Lines 12hour Zero
-1
17
Calculated CV = 0.8%
2
Difference percent 0
16
12hour
0
Bias Lines 12hour Zero
-1
-2
-2
30
35
40
45
Mean percent
VS8114-WP
50
55
70
80
90
100
Mean fL
19
MCH
MCHC Calculated CV = 0.6%
1.0
12hour
Difference g/dL
Calculated CV = 1.1%
0.5 0.5
Difference pg 0.0
Bias Lines 12hour Zero
12hour
0.0
Bias Lines 12hour Zero
-0.5 -0.5
-1.0
20
25
30
35
32
33
34
35
Mean pg
Mean g/dL
NE
LY Calculated SD = 2.09
Calculated SD = 1.17
4
5
Difference percent
2
0
12hour
Difference percent
12hour
Bias Lines 12hour Zero
0
Bias Lines 12hour Zero
-2
-5 -4
40
50
60
70
20
30
40
Mean percent
Mean percent
MO
EO Calculated SD = 1.26
4
2
50
Calculated SD = 0.352
1.0
0.5
Difference percent 0
12hour
Difference percent
12hour
Bias Lines 12hour Zero
0.0
Bias Lines 12hour Zero
-0.5
-2
-1.0 -4 4
6
8
10
12
Mean percent
20
14
16
0
2
4
6
8
10
12
Mean percent
VS8114-WP
BA
RETIC Calculated SD = 1.12
4
Calculated SD = 0.228
0.6
0.4 2
Difference percent
12hour
0
Bias Lines 12hour Zero
-2
0.2
12hour
Difference percent 0.0
Bias Lines 12hour Zero
-0.2
-0.4 -4 -0.6
0
1
2
Mean percent
VS8114-WP
3
0.0
0.5
1.0
1.5
2.0
2.5
Mean percent
21
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