Pilot Study to Compare Serology Results From Blood Collected Using Tasso-SST OnDemand Device Compared to Venipuncture
Phase: NA
Conditions: C3PI Study Testing Group
Sponsor: Duke University

 
 
 
 
 
Pilot study to compare serology results from blood collected using Tasso-SST OnDemand device 
compared to venipuncture 
 
Document Date: November 23, 2021 
NCT04713748 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
The purpose of this pilot study is participant user acceptance testing of the Tasso-SST OnDemand device 
to collect blood for antibody testing.  The study will also compare antibody testing results from blood 
collected using the Tasso-SST On-Demand device compared to blood collected by phlebotomy. 
 
Background & Significance 
 
Coming into a research clinic site is an exposure risk for participants and staff.  Coming into a research 
clinic site is a study burden for participants.  The Tasso-SST OnDemand device could provide a means for 
participants to collect samples at home and ship directly to the lab.  
 
The Tasso-SST OnDemand device, specifically the SST tube, is not approved for sars-cov-2 serology. We 
are testing it in a pilot study to confirm similar result from serum processed from blood collected by 
Tasso-SST OnDemand device and standard venipuncture (collection by standard venipuncture is part of 
study procedures for the MURDOCK C3PI Study (Pro00105703)).  Results from this pilot study will help 
inform the possibility of at-home specimen collection for serology testing.  We also hope to gain insight 
from participants about the instructions, and their willingness and ability to use it on their own, at 
home, in the future. 
 
Design & Procedures 
 
Prospective participants will receive an invitation from the PI via recruitment email to review the 
electronic consent form in Duke REDCap.  Participants are instructed to call or email the Duke CTSI 
Office in Kannapolis with any questions.  We will use the e-consent module in Duke REDCap.  We have 
engaged DOCR to ensure that the e-consent used for the study is compliant.  The identity of the 
consenting participant will be verified by the following steps: 1) participant will enter first and last name, 
date of birth, and email address, which will be verified against our records on file.  Study team will be 
alerted to any discrepancies.  The identity of participants will be further confirmed at the study visit, and 
done prior to completion of any study procedures. 
 
At the study visit, participants will collect a small blood sample using the Tasso-SST OnDemand device 
during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703).  
Participants will be provided a kit that includes written, step-by-step instructions that include pictures.  
Participants will also have the option to watch a brief video on using the device, available online at the 
Tasso website, prior to collection (https://www.tassoinc.com/tasso-sst-help). The Tasso-SST OnDemand 
device collects whole capillary blood, at a minimum volume of 80ul. In section 3100 of this application as 
the iRIS does not take any decimals’ and hence have 1ml as the max amount of blood drawn. 
 
A standard blood draw will also be done as described in the MURDOCK C3PI Study research summary 
and informed consent (Pro00105703). Both blood samples will be spun and processed for serum.  Serum 
will be frozen and shipped to the lab at Duke for antibody testing. Antibody results will be compared 
between the two methods. 
 

Participants will be sent a brief survey to learn about their experience using the Tasso-SST OnDemand 
device. 
 
Selection of Subjects 
  
Inclusion Criteria 
• 
Must be a study participant enrolled in the MURDOCK C3PI Study (Pro00105703), participating 
in the testing cohort of the study.   
• 
Participants are therefore 18 years of age or older, and willing to read and complete the consent 
process. 
 
No exclusion criteria; however, only up to 100 participants will be enrolled.  If more than 100 
participants sign consent, some interested participants may not take part in the study. 
 
Study Interventions 
 
Participants will collect blood on their own using the Tasso-SST OnDemand device, following instructions 
provided in the kit. The Tasso-SST OnDemand device collects whole capillary blood, at a minimum 
volume of 80ul. Collected blood is spun into serum, frozen and shipped to the lab for analysis. 
 
The Tasso-SST OnDemand device sticks to the skin with a light adhesive. When the button is pressed, a 
vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of the capillaries 
and into a tube attached to the bottom of the device.   
 
Data Analysis & Statistical Considerations 
 
We will evaluate correlation between results from blood collected by the two methods in this pilot study 
and qualitatively exam participant survey results.  Summary statistics will be generated for survey 
responses, and qualitative data will be reviewed.  
 
Data & Safety Monitoring 
 
Participants will be instructed to follow the provided directions, step-by-step, and have the option to 
watch an instructional video prior to use.  Participants will be observed by trained staff in a clinical 
research setting while using the Tasso device.  The participant may choose not to participate at any 
time.