Acute Disease, Disease, Chronic, Healthy, Sample Collection
Conditions
Keywords
sample collection device
Brief summary
This study designed to evaluate the safety and effectiveness of a newly developed sample collection device. Participants will be enrolled and samples will be collected by representative future users of the device. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be tested and average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations will be captured and device safety will be assessed.
Detailed description
The current method for collection of a large volume of capillary blood (up to 600 µL) involves optional warming of the hand or finger prior to procedure, lancing of the fingertip, squeezing the fingertip by hand, and dripping the blood into an open non-sterile tube. The capillary blood collection process is considered cumbersome and lacks standardization in how much pressure is applied in squeezing of the finger which may lead to poor sample quality or insufficient blood volume. Common sample quality issues for capillary blood collection include hemolysis and dilution of sample with interstitial fluid, potentially causing bias in test results. Open collection also carries a risk of blood exposure for healthcare workers and potential risk of infection at the finger puncture site. A new device, BD Microtainer® Easy Collect Capillary Blood Collection System for the collection of capillary blood was created to standardize the current collection process and improve sample quality. This study designed to evaluate the safety and effectiveness of the BD Microtainer® Easy Collect Capillary Tube SST™ and BD Microtainer® Easy Collect Capillary Tube EDTA devices. This study will be conducted in two parts, one for the SST product and the other for the EDTA product. A minimum of 100 participants, and a maximum of 150 participants per part will be enrolled at a minimum of three various ancillary healthcare site settings representative of the intended use environment such as retail pharmacy site, patient service center, and/or urgent care clinic. Samples will be collected by representative future users of the BD Microtainer® Easy Collect Capillary Blood Collection System who may not have prior blood collection experience. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be collected, clotted (serum samples only) and centrifuged (serum samples only) before transportation to the laboratory where they will be tested. Average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations for the SST products will be captured which include hemolysis as measured by Plasma Free Hemoglobin (PFH); collection volume; and duration of sample collection. Visual Observations for the EDTA products will be captured which include frequency of occurrence of instrument flags; frequency of occurrence of platelet clump instrument flags; frequency of instrument platelet clump flags with no platelet clump; evaluate whole blood collection volume; and duration of sample collection. Lastly, device safety will be assessed by device and procedure related adverse events.
Interventions
DEVICECapillary Blood Collection System
Test Blood Sample Collection
Sponsors
Babson Diagnostics
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants ≥18 years of age. * Not currently pregnant (self-reported) * Adequate access to four fingers (ring and middle finger on each hand) and inner elbows for blood collection procedures * Willing and able to comply with all study procedures and evaluations * Ability to read, write, and understand English language * Provision of signed and dated informed consent form
Exclusion criteria
* Evidence of skin issues such as infections, ulcerations, blisters, peripheral vascular disease, inflammation, extensive scarring or calluses, or healed burns at the fingerstick site. Subject to post-study exclusion period for this or other related studies: 1. A study participant may enroll once in study part A and once in study part B of this clinical study. They may not enroll more than once in a single study part. 2. If a study participant has previously enrolled in one study part and would like to enroll in the second study part, they must wait 8 days from the time of the first study part collection procedures to enroll in the second study part collection procedures. * Any condition which, in the opinion of the Investigator, would preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | 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 |
| White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | within 2 hours of sample collection | 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 |
| Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | 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 |
| Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | 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 |
| Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | 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 |
| Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | 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 |
| Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | 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 |
| White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | within 2 hours of sample collection | 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 |
| Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | within 2 hours of sample collection | 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 |
| Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | within 2 hours of sample collection | 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 |
| Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | within 2 hours of sample collection | 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 |
| Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | within 2 hours of sample collection | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | within 4 hours of sample collection | To 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 |
| Serum Collection Volume of the Test Device SST Tube | within 4 hours of sample collection | To evaluate serum collection volume of the Test Device SST tube |
| Duration of Sample Collection for Test Device SST Tube and Comparator Tube | within 4 hours of sample collection | To evaluate duration of sample collection for Test Device SST tube tube and capillary comparator. |
| Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types | within 4 hours of sample collection | 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 |
| Whole Blood Collection Volume for the Test Device EDTA | within 4 hours of sample collection | To evaluate whole blood collection volume for the Test Device EDTA |
| Duration of Sample Collection for the Test Device EDTA and Capillary Comparator | within 4 hours of sample collection | To evaluate duration of sample collection for the Test Device EDTA and capillary comparator |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Product BD MiniDraw™ Capillary Blood Collection System
Capillary Blood Collection System: Test Blood Sample Collection | 262 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Part A: Serum | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Test Product | — |
|---|---|---|
| Age, Customized Age over 18 | 262 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Sex/Gender Female | 149 Participants | — |
| Sex/Gender, Customized Sex/Gender Male | 96 Participants | — |
| Sex/Gender, Customized Sex/Gender not reported | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 262 | 0 / 262 |
| other Total, other adverse events | 0 / 262 | 0 / 262 |
| serious Total, serious adverse events | 0 / 262 | 0 / 262 |
Outcome results
Primary
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
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
Time frame: within 4 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
Primary
Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
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
Time frame: within 4 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
Comparison: One hundred (100) participants (with paired numerical data) per each analyte provide \> 90% power to ensure that mean biases and confidence intervals are within the clinical acceptance limit (CAL), at medically relevant points, assuming no true bias between the tube types, residual standard deviation (SD) or coefficient of variation (CV) = CAL and collected data cover medically relevant points.
Primary
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
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
Time frame: within 2 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | HGB Capillary Comparator EDTA | 13.33 g/dL |
| Test Product | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | HGB Venous comparator EDTA | 13.13 g/dL |
| Test Product | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | HGB Test Device EDTA | 13.45 g/dL |
| Test Product | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | MCHC Capillary Comparator EDTA | 33.81 g/dL |
| Test Product | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | MCHC Venous comparator EDTA | 33.4 g/dL |
| Test Product | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | MCHC Test Device EDTA | 33.69 g/dL |
Primary
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
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
Time frame: within 4 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | BUN Capillary Comparator SST™ | 22 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Ca Capillary Comparator SST™ | 9.52 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Chol Capillary Comparator SST™ | 192.8 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Creat Capillary Comparator SST™ | 2.432 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | GLUC Capillary Comparator SST™ | 159.1 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | HDL Capillary Comparator SST™ | 52.54 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | LDL Capillary Comparator SST™ | 132.76 mg/dL |
| Test Product | 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 |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | TBIL Capillary Comparator SST™ | 1.8763 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Triglycerides (Trig) Test Device SST™ | 155 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Trig Capillary Comparator SST™ | 158.6 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | BUN Venous comparator Serum | 20.4 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Ca Venous comparator Serum | 9.51 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Chol Venous comparator Serum | 195.8 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Creat Venous comparator Serum | 2.11 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | GLUC Venous comparator Serum | 149.4 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | HDL Venous comparator Serum | 54.83 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | LDL Venous comparator Serum | 140.78 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | TBIL Venous comparator Serum | 1.7931 mg/dL |
| Test Product | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Trig Venous comparator Serum | 157.9 mg/dL |
Primary
Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
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
Time frame: within 2 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | MCH Capillary Comparator EDTA | 30.22 pg |
| Test Product | Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | MCH Venous comparator EDTA | 30.12 pg |
| Test Product | Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | MCH Test Device EDTA | 30.21 pg |
Primary
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
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
Time frame: within 2 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
Primary
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
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
Time frame: within 4 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | chloride (CL) Test Device SST™ | 107.37 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | CL Capillary Comparator SST™ | 107.11 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Carbon Dioxide (CO2) Test Device SST™ | 21.72 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | CO2 Capillary Comparator SST™ | 24.02 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | potassium (K) Test Device SST™ | 4.436 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | K Capillary Comparator SST™ | 4.506 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Sodium (Na) Test Device SST™ | 138.29 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Na Capillary Comparator SST™ | 139.08 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | CL Venous comparator Serum | 104.94 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | CO2 Venous comparator Serum | 28.2 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | K Venous comparator Serum | 4.228 mmol/L |
| Test Product | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | Na Venous comparator Serum | 139.33 mmol/L |
Primary
Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
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
Time frame: within 2 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | RBC Capillary Comparator EDTA | 4.43 10^6 cells per µL |
| Test Product | Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | RBC Venous comparator EDTA | 4.375 10^6 cells per µL |
| Test Product | Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | RBC Test Device EDTA | 4.471 10^6 cells per µL |
Primary
Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples
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
Time frame: within 4 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples | TSH Test Device SST™ | 4.7599 µIU/mL |
| Test Product | Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples | TSH Capillary Comparator SST™ | 5.4529 µIU/mL |
| Test Product | Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples | TSH Venous comparator Serum | 5.4211 µIU/mL |
Primary
Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples
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
Time frame: within 4 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples | Vit D Test Device SST™ | 41.784 ng/mL |
| Test Product | Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples | Vit D Capillary Comparator SST™ | 36.786 ng/mL |
| Test Product | Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples | Vit D Venous comparator Serum | 37.603 ng/mL |
Primary
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
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
Time frame: within 2 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
Primary
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
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
Time frame: within 2 hours of sample collection
Population: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | PLT Venous comparator EDTA | 297 10^3 cells per µL |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
Other Pre-specified
Duration of Sample Collection for Test Device SST Tube and Comparator Tube
To evaluate duration of sample collection for Test Device SST tube tube and capillary comparator.
Time frame: within 4 hours of sample collection
Population: time to fill tube
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Duration of Sample Collection for Test Device SST Tube and Comparator Tube | Capillary Comparator SST™ | 108.7 seconds |
| Test Product | Duration of Sample Collection for Test Device SST Tube and Comparator Tube | Test Device SST™ | 128.0 seconds |
Other Pre-specified
Duration of Sample Collection for the Test Device EDTA and Capillary Comparator
To evaluate duration of sample collection for the Test Device EDTA and capillary comparator
Time frame: within 4 hours of sample collection
Population: samples from tubes filled
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Duration of Sample Collection for the Test Device EDTA and Capillary Comparator | Capillary Comparator EDTA | 95.8 s |
| Test Product | Duration of Sample Collection for the Test Device EDTA and Capillary Comparator | Test Device EDTA | 81 s |
Other Pre-specified
Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types
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
Time frame: within 4 hours of sample collection
Population: samples from tubes collected from participants.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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
Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples
To 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
Time frame: within 4 hours of sample collection
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Product | Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | Test Device SST™ | 20.2659 mg/dL |
| Test Product | Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | Capillary Comparator SST™ | 44.9719 mg/dL |
| Test Product | Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | Venous comparator SST™ | 11.2487 mg/dL |
| Test Product | Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | Venous comparator Serum | 9.8032 mg/dL |
Other Pre-specified
Serum Collection Volume of the Test Device SST Tube
To evaluate serum collection volume of the Test Device SST tube
Time frame: within 4 hours of sample collection
Population: samples for collection volume
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Product | Serum Collection Volume of the Test Device SST Tube | 236.41521 uL |
Other Pre-specified
Whole Blood Collection Volume for the Test Device EDTA
To evaluate whole blood collection volume for the Test Device EDTA
Time frame: within 4 hours of sample collection
Population: samples from tubes collected
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Product | Whole Blood Collection Volume for the Test Device EDTA | 299.37786 uL |