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

Trial Summary

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 data supports the effectiveness of the Tasso+ treatment for blood sample collection?

Research shows that the Tasso-SST device, similar to Tasso+, is effective for self-collecting blood samples, with high accuracy and reliability compared to traditional methods like venipuncture. In studies, the results from Tasso-SST self-collected samples closely matched those from professionally collected samples, indicating it is a viable alternative for blood sample collection. ^{1 2 3 4 5}

Is the Tasso+ Self-Collection method for blood sample collection safe for humans?

The Tasso+ Self-Collection method, similar to other self-collection methods like dried blood spots, is generally considered safe and is a less invasive alternative to traditional blood draws. Recommendations for safe blood collection practices have been established to ensure patient safety and improve the quality of blood collection. ^{5 6 7 8 9}

How is the Tasso+ treatment different from other treatments for blood sample collection?

Tasso+ is unique because it allows individuals to collect their own blood samples at home using a simple device, which reduces the need for in-person visits and minimizes exposure risks, especially during pandemics like COVID-19. This self-collection method is as accurate as traditional blood draws performed by healthcare professionals, making it a convenient and reliable alternative. ^{1 2 3 4 10}

What is the purpose of this trial?

This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of various biomarkers. The study will collect blood specimens using both the Tasso+ self-collection device and traditional venipuncture. The biomarker analysis results from both specimen types will be compared for correlation.

Research Team

Sri Bharat Madireddy, Ph.D.

Principal Investigator

American Research Labs

Vanaja Reddy Bodeddula, Ph.D.

Principal Investigator

American Research Labs

Eligibility Criteria

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

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

Sample type: Participants must be willing and able to provide human specimens such as blood, urine, or saliva

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2023]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Self-collection of capillary blood using Tasso-SST devices for Anti-SARS-CoV-2 IgG antibody testing. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of a Blood Self-Collection System with Routine Phlebotomy for SARS-CoV-2 Antibody Testing. [2023]

5. England 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. [2023]

6. Germany 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). [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Joint EFLM-COLABIOCLI recommendation for venous blood sampling]. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Joint EFLM-COLABIOCLI Recommendation for venous blood sampling [2022]

9. England pubmed.ncbi.nlm.nih.gov

HbA1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis. [2022]

10. United States 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. [2022]