BD MiniDraw™ Capillary System Clinical Equivalence Study

A Prospective Multi-center Study to Evaluate Clinical Equivalence (Method Comparison) Between the BD MiniDraw™ SST™ Capillary Blood Collection Tube and BD MiniDraw™ EDTA Capillary Blood Collection Tube to Respective Comparators

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Acute Disease; Disease, Chronic; Sample Collection
• Intervention / Treatment: Device: Capillary Blood Collection System

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.

• Study Type: Interventional
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78753
      • Babson Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product; BD MiniDraw™ Capillary Blood Collection System	Device: Capillary Blood Collection System; Test Blood Sample Collection; Other Names: BD MiniDraw™ Capillary System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 4 hours of sample collection
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	within 2 hours of sample collection
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	within 4 hours of sample collection
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	within 4 hours of sample collection
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	within 4 hours of sample collection
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	within 4 hours of sample collection
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	within 4 hours of sample collection
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	within 2 hours of sample collection
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	within 2 hours of sample collection
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	within 2 hours of sample collection
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	within 2 hours of sample collection
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	within 2 hours of sample collection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Collection Volume of the Test Device SST Tube	To evaluate serum collection volume of the Test Device SST tube	within 4 hours of sample collection
Whole Blood Collection Volume for the Test Device EDTA	To evaluate whole blood collection volume for the Test Device EDTA	within 4 hours of sample collection
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	within 4 hours of sample collection
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	within 4 hours of sample collection
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.	within 4 hours of sample collection
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	within 4 hours of sample collection

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Collaborators: Babson Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: sample collection device
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Acute Disease
• Other Study ID Numbers: PAS-21YODA005