Trial Outcomes & Findings for BD MiniDraw™ Capillary System Clinical Equivalence Study (NCT NCT05186311)
NCT ID: NCT05186311
Last Updated: 2023-11-03
Results Overview
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of g/dL
Recruitment status
COMPLETED
Target enrollment
262 participants
Primary outcome timeframe
within 4 hours of sample collection
Results posted on
2023-11-03
Participant Flow
Participant milestones
| Measure |
Test Product
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Part A: Serum
STARTED
|
136
|
|
Part A: Serum
COMPLETED
|
135
|
|
Part A: Serum
NOT COMPLETED
|
1
|
|
Part B: EDTA
STARTED
|
126
|
|
Part B: EDTA
COMPLETED
|
125
|
|
Part B: EDTA
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Test Product
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Part A: Serum
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test Product
n=262 Participants
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Age, Customized
Age over 18
|
262 Participants
n=262 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
149 Participants
n=262 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
96 Participants
n=262 Participants
|
|
Sex/Gender, Customized
Sex/Gender · not reported
|
17 Participants
n=262 Participants
|
PRIMARY outcome
Timeframe: within 4 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of g/dL
Outcome measures
| Measure |
Test Product
n=102 Blood Sample
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
ALB Test Device SST™
|
3.746 g/dL
Interval 1.01 to 5.54
|
|
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
ALB Capillary Comparator SST™
|
3.787 g/dL
Interval 1.01 to 5.58
|
|
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
TP Test Device SST™
|
6.77 g/dL
Interval 2.6 to 10.2
|
|
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
TP Capillary Comparator SST™
|
6.83 g/dL
Interval 2.7 to 10.2
|
|
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
ALB Venous comparator Serum
|
3.791 g/dL
Interval 1.0 to 5.44
|
|
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
TP Venous comparator Serum
|
6.78 g/dL
Interval 2.6 to 9.8
|
PRIMARY outcome
Timeframe: within 2 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators venous comparator and capillary comparator. This comparison was focused on the analytes with a unit of percentage
Outcome measures
| Measure |
Test Product
n=117 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Basophils (BA)% Test Device EDTA
|
0.73 % of analyte in the sample
Interval 0.0 to 2.0
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
BA% Capillary Comparator EDTA
|
0.71 % of analyte in the sample
Interval 0.0 to 1.9
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
BA% Venous comparator EDTA
|
0.71 % of analyte in the sample
Interval 0.0 to 1.8
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Eosinophils (EO)% Capillary Comparator EDTA
|
2.97 % of analyte in the sample
Interval 0.0 to 12.0
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
EO% Venous comparator EDTA
|
3.16 % of analyte in the sample
Interval 0.0 to 16.0
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
EO% Test Device EDTA
|
2.89 % of analyte in the sample
Interval 0.0 to 10.7
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
hemoglobin A1c (HbA1c) Capillary Comparator EDTA
|
5.938 % of analyte in the sample
Interval 4.2 to 14.2
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HbA1c Venous comparator EDTA
|
5.965 % of analyte in the sample
Interval 4.6 to 14.1
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HbA1c Test Device EDTA
|
5.934 % of analyte in the sample
Interval 4.2 to 14.2
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HCT Capillary Comparator EDTA
|
39.41 % of analyte in the sample
Interval 19.2 to 73.6
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Hematocrit (HCT) Venous comparator EDTA
|
39.26 % of analyte in the sample
Interval 18.5 to 73.8
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HCT Test Device EDTA
|
39.9 % of analyte in the sample
Interval 19.1 to 73.1
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Lymphocytes (LY)% Capillary Comparator EDTA
|
27.93 % of analyte in the sample
Interval 7.2 to 67.7
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
LY% Venous comparator EDTA
|
27.85 % of analyte in the sample
Interval 7.4 to 67.2
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
LY% Test Device EDTA
|
27.69 % of analyte in the sample
Interval 6.8 to 67.5
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Monocytes (MO)% Capillary Comparator EDTA
|
8.4 % of analyte in the sample
Interval 3.8 to 22.3
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MO% Venous comparator EDTA
|
8.49 % of analyte in the sample
Interval 4.0 to 19.4
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MO% Test Device EDTA
|
8.6 % of analyte in the sample
Interval 4.2 to 20.7
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Neutrophils (NE)% Capillary Comparator EDTA
|
59.51 % of analyte in the sample
Interval 9.5 to 84.3
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
NE% Venous comparator EDTA
|
59.39 % of analyte in the sample
Interval 9.2 to 84.4
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
NE% Test Device EDTA
|
59.7 % of analyte in the sample
Interval 10.5 to 84.2
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Red Blood Cell Distribution Width (RDW)-CV Capillary Comparator EDTA
|
13.54 % of analyte in the sample
Interval 11.4 to 24.0
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RDW-CV Venous comparator EDTA
|
13.67 % of analyte in the sample
Interval 11.4 to 23.9
|
|
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RDW-CV Test Device EDTA
|
13.55 % of analyte in the sample
Interval 11.4 to 24.0
|
PRIMARY outcome
Timeframe: within 4 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of µIU/mL
Outcome measures
| Measure |
Test Product
n=94 Participants
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples
TSH Test Device SST™
|
4.7599 µIU/mL
Interval 0.183 to 97.892
|
|
Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples
TSH Capillary Comparator SST™
|
5.4529 µIU/mL
Interval 0.181 to 104.351
|
|
Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples
TSH Venous comparator Serum
|
5.4211 µIU/mL
Interval 0.188 to 101.313
|
PRIMARY outcome
Timeframe: within 4 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mg/dL
Outcome measures
| Measure |
Test Product
n=102 Participants
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
blood urea nitrogen (BUN) Test Device SST™
|
21.9 mg/dL
Interval 8.0 to 115.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
BUN Capillary Comparator SST™
|
22 mg/dL
Interval 7.0 to 115.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Calcium (Ca) Test Device SST™
|
9.43 mg/dL
Interval 2.7 to 13.6
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Ca Capillary Comparator SST™
|
9.52 mg/dL
Interval 2.7 to 13.5
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
cholesterol (Chol) Test Device SST™
|
190.2 mg/dL
Interval 51.0 to 454.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Chol Capillary Comparator SST™
|
192.8 mg/dL
Interval 51.0 to 457.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Creatinine (Creat) Test Device SST™
|
2.418 mg/dL
Interval 0.23 to 19.93
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Creat Capillary Comparator SST™
|
2.432 mg/dL
Interval 0.22 to 20.03
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Glucose (GLUC) Test Device SST™
|
158.2 mg/dL
Interval 36.0 to 1434.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
GLUC Capillary Comparator SST™
|
159.1 mg/dL
Interval 37.0 to 1443.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
high-density lipoprotein (HDL) Test Device SST™
|
51.28 mg/dL
Interval 21.5 to 96.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
HDL Capillary Comparator SST™
|
52.54 mg/dL
Interval 21.7 to 99.5
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
low-density lipoprotein (LDL) Test Device SST™
|
131.07 mg/dL
Interval 32.8 to 612.4
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
LDL Capillary Comparator SST™
|
132.76 mg/dL
Interval 33.1 to 609.2
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Total Bilirubin (TBIL) Test Device SST™
|
1.8604 mg/dL
Interval 0.17 to 26.42
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
TBIL Capillary Comparator SST™
|
1.8763 mg/dL
Interval 0.18 to 26.519
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Triglycerides (Trig) Test Device SST™
|
155 mg/dL
Interval 32.0 to 730.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Trig Capillary Comparator SST™
|
158.6 mg/dL
Interval 33.0 to 739.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
BUN Venous comparator Serum
|
20.4 mg/dL
Interval 6.0 to 115.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Ca Venous comparator Serum
|
9.51 mg/dL
Interval 2.9 to 13.6
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Chol Venous comparator Serum
|
195.8 mg/dL
Interval 59.0 to 456.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Creat Venous comparator Serum
|
2.11 mg/dL
Interval 0.22 to 19.87
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
GLUC Venous comparator Serum
|
149.4 mg/dL
Interval 36.0 to 1428.0
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
HDL Venous comparator Serum
|
54.83 mg/dL
Interval 21.5 to 109.6
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
LDL Venous comparator Serum
|
140.78 mg/dL
Interval 35.1 to 610.6
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
TBIL Venous comparator Serum
|
1.7931 mg/dL
Interval 0.18 to 26.653
|
|
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Trig Venous comparator Serum
|
157.9 mg/dL
Interval 32.0 to 739.0
|
PRIMARY outcome
Timeframe: within 4 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mmol/L
Outcome measures
| Measure |
Test Product
n=102 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
chloride (CL) Test Device SST™
|
107.37 mmol/L
Interval 73.2 to 146.0
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
CL Capillary Comparator SST™
|
107.11 mmol/L
Interval 73.0 to 145.0
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Carbon Dioxide (CO2) Test Device SST™
|
21.72 mmol/L
Interval 14.0 to 33.8
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
CO2 Capillary Comparator SST™
|
24.02 mmol/L
Interval 16.0 to 34.2
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
potassium (K) Test Device SST™
|
4.436 mmol/L
Interval 2.14 to 8.15
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
K Capillary Comparator SST™
|
4.506 mmol/L
Interval 2.12 to 8.1
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Sodium (Na) Test Device SST™
|
138.29 mmol/L
Interval 90.8 to 166.0
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Na Capillary Comparator SST™
|
139.08 mmol/L
Interval 90.9 to 166.0
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
CL Venous comparator Serum
|
104.94 mmol/L
Interval 72.4 to 145.0
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
CO2 Venous comparator Serum
|
28.2 mmol/L
Interval 16.4 to 35.2
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
K Venous comparator Serum
|
4.228 mmol/L
Interval 2.15 to 8.16
|
|
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Na Venous comparator Serum
|
139.33 mmol/L
Interval 92.4 to 166.0
|
PRIMARY outcome
Timeframe: within 4 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of ng/mL
Outcome measures
| Measure |
Test Product
n=99 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples
Vit D Test Device SST™
|
41.784 ng/mL
Interval 10.11 to 103.56
|
|
Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples
Vit D Capillary Comparator SST™
|
36.786 ng/mL
Interval 8.33 to 90.78
|
|
Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples
Vit D Venous comparator Serum
|
37.603 ng/mL
Interval 8.31 to 99.74
|
PRIMARY outcome
Timeframe: within 4 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of U/L
Outcome measures
| Measure |
Test Product
n=97 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
ALKP Test Device SST™ SST™
|
98.6 U/L
Interval 31.0 to 644.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
ALKP Capillary Comparator SST™
|
98.9 U/L
Interval 31.0 to 646.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
ALT Test Device SST™
|
50.2 U/L
Interval 8.0 to 756.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
ALT Capillary Comparator SST™
|
51 U/L
Interval 8.0 to 759.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
AST Test Device SST™
|
47.4 U/L
Interval 11.0 to 717.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
AST Capillary Comparator SST™
|
49.5 U/L
Interval 10.0 to 719.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
ALKP Venous comparator Serum
|
100.4 U/L
Interval 31.0 to 649.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
ALT Venous comparator Serum
|
50.4 U/L
Interval 9.0 to 760.0
|
|
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
AST Venous comparator Serum
|
45.7 U/L
Interval 10.0 to 720.0
|
PRIMARY outcome
Timeframe: within 2 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10\^3/µL
Outcome measures
| Measure |
Test Product
n=117 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
PLT Capillary Comparator EDTA
|
275.3 10^3 cells per µL
Interval 33.0 to 2967.0
|
|
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
PLT Venous comparator EDTA
|
297 10^3 cells per µL
Interval 34.0 to 2978.0
|
|
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
PLT Test Device EDTA
|
262.1 10^3 cells per µL
Interval 31.0 to 2964.0
|
|
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
WBC Capillary Comparator EDTA
|
12.647 10^3 cells per µL
Interval 2.28 to 267.31
|
|
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
WBC Venous comparator EDTA
|
12.453 10^3 cells per µL
Interval 2.01 to 265.52
|
|
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
WBC Test Device EDTA
|
12.746 10^3 cells per µL
Interval 2.39 to 265.5
|
PRIMARY outcome
Timeframe: within 2 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10\^6/µL
Outcome measures
| Measure |
Test Product
n=117 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RBC Capillary Comparator EDTA
|
4.43 10^6 cells per µL
Interval 1.93 to 8.6
|
|
Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RBC Venous comparator EDTA
|
4.375 10^6 cells per µL
Interval 1.87 to 8.62
|
|
Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RBC Test Device EDTA
|
4.471 10^6 cells per µL
Interval 1.93 to 8.5
|
PRIMARY outcome
Timeframe: within 2 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of fL
Outcome measures
| Measure |
Test Product
n=108 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCV Capillary Comparator EDTA
|
89.38 fL
Interval 75.9 to 104.4
|
|
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCV Venous comparator EDTA
|
90.16 fL
Interval 75.5 to 104.4
|
|
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCV Test Device EDTA
|
89.66 fL
Interval 75.6 to 104.6
|
|
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RDW-SD Capillary Comparator EDTA
|
44.14 fL
Interval 36.3 to 86.9
|
|
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RDW-SD Venous comparator EDTA
|
44.97 fL
Interval 37.3 to 86.0
|
|
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
RDW-SD Test Device EDTA
|
44.32 fL
Interval 36.5 to 84.5
|
PRIMARY outcome
Timeframe: within 2 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of g/dL
Outcome measures
| Measure |
Test Product
n=117 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HGB Capillary Comparator EDTA
|
13.33 g/dL
Interval 6.2 to 25.5
|
|
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HGB Venous comparator EDTA
|
13.13 g/dL
Interval 6.1 to 25.4
|
|
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
HGB Test Device EDTA
|
13.45 g/dL
Interval 6.2 to 25.3
|
|
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCHC Capillary Comparator EDTA
|
33.81 g/dL
Interval 31.2 to 36.6
|
|
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCHC Venous comparator EDTA
|
33.4 g/dL
Interval 30.7 to 36.2
|
|
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCHC Test Device EDTA
|
33.69 g/dL
Interval 31.5 to 36.3
|
PRIMARY outcome
Timeframe: within 2 hours of sample collectionPopulation: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of pg
Outcome measures
| Measure |
Test Product
n=108 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCH Capillary Comparator EDTA
|
30.22 pg
Interval 24.1 to 36.6
|
|
Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCH Venous comparator EDTA
|
30.12 pg
Interval 23.5 to 36.4
|
|
Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
MCH Test Device EDTA
|
30.21 pg
Interval 24.4 to 35.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of sample collectionTo evaluate sample hemolysis as measured by Plasma Free Hemoglobin (PFH) for BD Microtainer® Easy Collect Capillary Tube SST™ and all comparator tube types: capillary and venous
Outcome measures
| Measure |
Test Product
n=254 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples
Test Device SST™
|
20.2659 mg/dL
Interval 18.119 to 22.4129
|
|
Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples
Capillary Comparator SST™
|
44.9719 mg/dL
Interval 38.9098 to 51.0339
|
|
Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples
Venous comparator SST™
|
11.2487 mg/dL
Interval 10.0577 to 12.4397
|
|
Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples
Venous comparator Serum
|
9.8032 mg/dL
Interval 8.3323 to 11.2742
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of sample collectionPopulation: samples for collection volume
To evaluate serum collection volume of the Test Device SST tube
Outcome measures
| Measure |
Test Product
n=208 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Serum Collection Volume of the Test Device SST Tube
|
236.41521 uL
Interval 231.51278 to 241.31763
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of sample collectionPopulation: time to fill tube
To evaluate duration of sample collection for Test Device SST tube tube and capillary comparator.
Outcome measures
| Measure |
Test Product
n=222 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Duration of Sample Collection for Test Device SST Tube and Comparator Tube
Capillary Comparator SST™
|
108.7 seconds
Interval 99.3 to 118.1
|
|
Duration of Sample Collection for Test Device SST Tube and Comparator Tube
Test Device SST™
|
128.0 seconds
Interval 117.5 to 138.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of sample collectionPopulation: samples from tubes collected from participants.
Evaluation of the frequency of occurrence of all instrument flags (both asterisks and IP messages) in the Test Device EDTA and all comparator tube types: venous and capillary tubes
Outcome measures
| Measure |
Test Product
n=124 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types
Test Device EDTA
|
30 Blood samples
|
|
Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types
Capillary Comparator EDTA
|
25 Blood samples
|
|
Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types
BD Venous comparator EDTA
|
5 Blood samples
|
|
Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types
Venous comparator EDTA
|
5 Blood samples
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of sample collectionPopulation: samples from tubes collected
To evaluate whole blood collection volume for the Test Device EDTA
Outcome measures
| Measure |
Test Product
n=121 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Whole Blood Collection Volume for the Test Device EDTA
|
299.37786 uL
Interval 290.6445 to 308.11119
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of sample collectionPopulation: samples from tubes filled
To evaluate duration of sample collection for the Test Device EDTA and capillary comparator
Outcome measures
| Measure |
Test Product
n=121 Blood samples
BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection
|
|---|---|
|
Duration of Sample Collection for the Test Device EDTA and Capillary Comparator
Capillary Comparator EDTA
|
95.8 s
Interval 84.7 to 106.8
|
|
Duration of Sample Collection for the Test Device EDTA and Capillary Comparator
Test Device EDTA
|
81 s
Interval 72.8 to 89.2
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60