Tasso+ Self-Collection for Blood Sample Collection

Overseen By Vanaja Reddy Bodeddula, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: American Research Labs

Disqualifiers: Blind, Decisionally impaired, Hospitalized, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

2500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, Tasso+, which allows individuals to collect their own blood samples at home. The goal is to determine if the Tasso+ device performs as effectively as the traditional needle method for checking specific health markers. It suits those who can follow simple instructions and feel comfortable taking their own blood samples. As an unphased trial, this study provides an opportunity to contribute to innovative healthcare solutions by evaluating a convenient, at-home blood collection method.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the study team.

What prior data suggests that the Tasso+ device is safe for blood collection?

Research has shown that the Tasso+ device is safe for collecting blood samples. This self-use tool has received FDA approval as a safe medical device. Studies indicate that the device is both safe and mostly painless for adults and children. It collects a small amount of blood through a simple process. No major side effects or problems have been reported. Overall, current evidence suggests that the Tasso+ device is well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tasso+ self-collection method because it offers a simple and convenient way for people to collect their own blood samples. Unlike traditional blood draws, which require a visit to a healthcare facility and a trained phlebotomist, Tasso+ allows individuals to collect blood using a small device at home. This method could make blood testing more accessible and less intimidating, encouraging more people to monitor their health regularly. Additionally, Tasso+ has the potential to provide results that are as reliable as those obtained through standard venipuncture, making it a promising alternative for routine blood testing.

What evidence suggests that the Tasso+ device is effective for blood sample collection?

Research has shown that the Tasso+ self-collection device effectively collects blood samples. In one study, 93% of participants successfully used the device to collect their samples, indicating a high success rate. Another study found that 94% of participants found it easy to use, and 95% felt confident using it at home. The device is also safe and mostly painless for both adults and children. In this trial, participants will have their blood collected using both the Tasso+ device and the traditional venipuncture method. These findings suggest that the Tasso+ device offers a reliable and convenient alternative to traditional methods like drawing blood with a needle. ^{2 6 7 8 9}

Who Is on the Research Team?

Vanaja Reddy Bodeddula, Ph.D.

Principal Investigator

American Research Labs

Sri Bharat Madireddy, Ph.D.

Principal Investigator

American Research Labs

Are You a Good Fit for This Trial?

This trial is for individuals aged 13 or older who can provide informed consent themselves, or through a parent or guardian if under 18. Participants must be able to understand the study materials and willing to provide blood, urine, or saliva samples.

Inclusion Criteria

Language proficiency: Participants must be able to read and understand the language used in study materials

I am 13 years old or older.

Medical history: No specific medical history requirements, but participants may need to meet certain general health criteria

Exclusion Criteria

Hospitalized: Participants who are currently hospitalized

Educationally disadvantaged: Participants who lack the education or literacy skills required to understand study procedures or provide informed consent

I am unable to make medical decisions due to a cognitive or mental health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blood Collection

Blood is collected using both traditional venipuncture and the Tasso+ self-collection device to assess biomarker correlation.

1-2 weeks

1 visit (in-person)

Analysis

Lab results are analyzed to assess the correlation of biomarkers between blood samples obtained using the Tasso+ device and those collected via venipuncture.

1 year

Follow-up

Participants are monitored for any adverse events and to collect patient experience with the Tasso+ blood collection device.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Tasso+
• Traditional Venipuncture

Trial Overview The study is testing the Tasso+ device for self-collecting blood against traditional venipuncture. It aims to see if this new method gives reliable results when checking various health markers in the blood.

How Is the Trial Designed?

Group I: Human Blood Specimen Collection Experimental Treatment 2 Interventions

Blood will be collected from each participant using two different methods: the Tasso+ device and the traditional venipuncture approach. Both collection procedures are carried out sequentially at the study site. A phlebotomist performs the traditional venipuncture and the participant collects blood using two Tasso+ devices, following provided instructions. The lab results will be analyzed to assess the correlation of biomarkers between blood samples obtained by the participant using the Tasso+ device and those collected via venipuncture.

Tasso+ is already approved in United States, European Union for the following indications:

Approved in United States as Tasso+ for:

• Clinical diagnostic assessment of various biomarkers

Approved in European Union as TassoOne Plus for:

• Clinical diagnostic assessment of various biomarkers

Who Is Running the Clinical Trial?

American Research Labs

Lead Sponsor

Trials

1

Recruited

2,500+

Published Research Related to This Trial

Dried blood spot (DBS) sampling is a feasible and less invasive method for collecting blood samples, with 74% of participants consenting to DBS collection when interviewed by a nurse, although only 35% consented in self-collection modes.

The study found that cardiovascular risk biomarkers measured from DBS samples were comparable to those from venous blood, indicating that DBS can effectively assess population levels of cardiovascular disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised study of nurse collected venous blood and self-collected dried blood spots for the assessment of cardiovascular risk factors in the Understanding Society Innovation Panel. Kumari, M., Andrayas, A., Al Baghal, T., et al.[2023]

The Tasso-SST device demonstrated a high success rate for self-collection of capillary blood, with 93.4% of unsupervised and 94.5% of supervised participants successfully using it.

The accuracy of SARS-CoV-2 IgG antibody measurements from Tasso-SST collected samples was excellent, showing 98.9% concordance with standard venous blood tests, making it a reliable option for remote testing without medical supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-collection of capillary blood using Tasso-SST devices for Anti-SARS-CoV-2 IgG antibody testing. Hendelman, T., Chaudhary, A., LeClair, AC., et al.[2021]

The Tasso Serum Separator Tube (SST) allows for self-collection of capillary blood, showing promise as a convenient alternative to traditional venous phlebotomy, especially in resource-limited settings.

While many protein biomarkers showed good correlation between Tasso SST and venous samples, significant differences in concentrations for certain analytes highlight the need for careful consideration of collection and processing conditions to ensure accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the use of a micro-sampling device for measuring blood protein levels in healthy subjects and COVID-19 patients. Brandsma, J., Chenoweth, JG., Gregory, MK., et al.[2022]

The joint recommendation by EFLM and COLABIOCLI provides evidence-based guidelines for safe and patient-centered venous blood sampling, focusing on a closed blood collection system to enhance safety during the procedure.

The recommendations cover pre-sampling, sampling, and post-sampling procedures, and have been endorsed by a majority of members from both organizations, encouraging widespread adoption to improve blood collection practices and ensure safety for patients and healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Joint EFLM-COLABIOCLI Recommendation for venous blood sampling Simundic, AM., Bölenius, K., Cadamuro, J., et al.[2022]

Self-collection of blood samples using the Tasso-SST device shows high correlation with traditional venous blood collection for measuring antibodies against SARS-CoV-2, making it a reliable method for at-home testing.

In a study of 26 participants, no discrepancies were found in antibody results between the two collection methods, supporting the feasibility of using Tasso devices for monitoring COVID-19 immunity, especially in vaccinated individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of capillary blood self-collection using the Tasso-SST device with venous phlebotomy for anti-SARS-CoV-2 antibody measurement. King, ER., Garrett, HE., Abernathy, H., et al.[2023]

Self-collection of blood samples using the Tasso-SST device shows high correlation with traditional venous blood collection for measuring antibodies against SARS-CoV-2, making it a reliable alternative for at-home testing.

In a study of 26 participants, no discrepancies were found in antibody results between the two collection methods, supporting the safety and efficacy of using Tasso devices for monitoring COVID-19 immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Capillary Blood Self-Collection using the Tasso-SST Device with Venous Phlebotomy for anti-SARS-CoV-2 Antibody Measurement. King, ER., Garrett, HE., Abernathy, H., et al.[2023]

The HemaSpot™ blood collection device shows strong accuracy in measuring HbA1c levels, with results from dried blood spots correlating well with traditional venous blood samples, based on a study of 128 adults with diabetes.

Patient acceptance is high, with 69.2% of participants expressing willingness to use the HemaSpot system, indicating it could be a convenient alternative for blood glucose monitoring, especially for those unable to visit clinics regularly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HbA1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis. Hall, JM., Fowler, CF., Barrett, F., et al.[2022]

A survey of 1347 laboratories across 37 European countries revealed that only about 13% of responders were unaware of the exact blood sampling time, indicating a significant gap in documentation practices, especially in Austria where the rate was as high as 30%.

The study identified eight potential solutions for improving the documentation of blood collection times, highlighting the urgent need for laboratories to standardize this practice to ensure the stability of laboratory analytes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exact time of venous blood sample collection - an unresolved issue, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE). von Meyer, A., Lippi, G., Simundic, AM., et al.[2021]

The joint recommendation by EFLM and COLABIOCLI provides evidence-based guidelines for safe and patient-centered venous blood sampling, focusing on a closed blood collection system to enhance safety during the procedure.

The recommendations cover pre-sampling, sampling, and post-sampling procedures, and have been endorsed by a majority of members from both organizations, encouraging widespread adoption to improve blood collection practices and ensure safety for patients and healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Joint EFLM-COLABIOCLI recommendation for venous blood sampling]. Simundic, AM., Bölenius, K., Cadamuro, J., et al.[2021]

In a pilot study involving 100 participants, the Tasso-SST device for self-collecting blood samples showed that 70% of users were able to collect adequate samples for SARS-CoV-2 antibody testing, indicating its feasibility for at-home testing.

The results from the Tasso-SST method were highly concordant with traditional phlebotomy methods, achieving a Cohen’s kappa coefficient of 0.88, suggesting that this device could be a reliable alternative for seroprevalence testing in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Blood Self-Collection System with Routine Phlebotomy for SARS-CoV-2 Antibody Testing. Wixted, D., Neighbors, CE., Pieper, CF., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218524/

Evaluation of the Tasso+ blood self-collection device for ... A Tasso + CB sample was successfully collected in 28/30 (93%) patients, and 44 paired samples were analyzed. Concordance for detection of CMV DNAemia above the ...

2. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07432-0

Feasibility of a novel self-collection method for blood samples ... Among 48 who completed blood collections, 94% found the Tasso device easy to use and 95% felt they could perform self-sampling at home. Of 27 ...

3. withpower.com withpower.com/trial/phase-blood-self-collection-for-clinical-diagnostic-assessments-4-2023-f84f2

Tasso+ Self-Collection for Blood Sample Collection This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05852925/evaluation-of-tasso-blood-self-collection-for-clinical-diagnostic-assessment-of-various-biomarkers

Evaluation of Tasso+ Blood Self-Collection for Clinical ... This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11135758/

Feasibility, acceptability, and safety of a novel device ... Capillary blood self-collection, yielding slightly less than 500 μl, proves to be a safe and relatively painless method for adults and children.

6. tassoinc.com tassoinc.com/tasso-plus

Tasso+ Tasso+ is FDA Class II Lancet 510(k)-cleared. For applications outside of the U.S., please visit our International page.

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0304155

Feasibility, acceptability, and safety of a novel device for self ... Capillary blood self-collection, yielding slightly less than 500 μl, proves to be a safe and relatively painless method for adults and children.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8412246/

Self-collection of capillary blood using Tasso-SST devices ... In this study, we sought to investigate the accuracy and reliability of the Tasso-SST device as a self-collection device for measurement of SARS-CoV-2 IgG ...

9. tassoinc.com tassoinc.com/press

Press Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+ ...