Evaluating Technologies for Point-of-Care Blood Collections by Patients

January 6, 2026 updated by: Alachua Government Services, Inc.

Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings

A study evaluating technologies for point-of-care use in clinical trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A study evaluating the Tasso+ blood collection device that enables the safe and convenient collection of blood by a lay person (eg, patient or study participant) under the supervision of an Health Care Provider.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Riverside, California, United States, 92503
        • Victor Salib

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female adults (18 years of age or older, inclusive), at the time of informed consent. Participants who are deemed pregnant by urine pregnancy test at Screening remain eligible.
  • Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
  • Participant considered healthy or in well-compensated health according to medical history, concomitant medications, and physical examination (including vital signs).

Exclusion Criteria:

  • Medical history, or physical examination (including vital signs) findings, that suggest to the Investigator that the participant has undiagnosed or untreated medical condition(s) that could confound the AE evaluation and thereby undermine the study objectives.
  • Any known medical history of infection with HIV (CD4<200 and/or detectable viral load within the prior 3 months), hepatitis B (positive HBsAg), or hepatitis C (positive hepatitis C virus antibody).
  • Chronic illness for which a participant's immune system is suspected by the Investigator to be impaired or altered, such as cancer, autoimmune conditions, and diabetes.
  • Participation in another investigational study within 30 days of time of consent or plans to do so during the course of this study.
  • Large tattoos or skin eruptions overlying either of the deltoid muscles that could confound the monitoring for local reactogenicity following Tasso+™ administrations.
  • Use of systemic immunomodulatory therapy, including oral corticosteroids, within the past 6 months; or planned use of medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to screening until end of study.
  • Acute illness within 14 days prior to device use unless it is determined by the Investigator that the illness is mild in severity and unlikely to progress.
  • Of limited legal capacity.
  • Any condition (including suspected alcohol- or drug-related addiction) that precludes adequate understanding, cooperation, and/or compliance with study procedures or any condition that could pose a risk to the participant's safety per Investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cohort A
Samples centrifuged/aliquoted after arrival at central lab.
Device: Tasso+™
The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
Active Comparator: Cohort B
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Device: Tasso+™
The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the Sample Integrity of Tasso+™
Time Frame: Day 1
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Day 1
Assess the Sample Integrity of Tasso+™
Time Frame: Day 29
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Day 29
Assess the Sample Integrity of Tasso+™
Time Frame: Day 57
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Day 57
Assess the Sample Integrity of Tasso+™
Time Frame: Day 1
Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
Day 1
Assess the Sample Integrity of Tasso+™
Time Frame: Day 29
Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
Day 29
Assess the Sample Integrity of Tasso+™
Time Frame: Day 57
Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
Day 57
Assess the Testing Accuracy of Tasso+™
Time Frame: Day 1
Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort A
Day 1
Assess the Testing Accuracy of Tasso+™
Time Frame: Day 1
Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort B
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Sodium
Time Frame: Day 1
Correlation of sodium between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Reliability of Tasso+™
Time Frame: Day 1
Percentage of Tasso+™ device failure
Day 1
To Assess the Reliability of Tasso+™
Time Frame: Day 29
Percentage of Tasso+™ device failure
Day 29
Assess the Reliability of Tasso+™
Time Frame: Day 57
Percentage of Tasso+™ device failure
Day 57
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Potassium
Time Frame: Day 1
Correlation of potassium between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Chloride
Time Frame: Day 1
Correlation of chloride between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Creatinine
Time Frame: Day 1
Correlation of creatinine between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Glucose
Time Frame: Day 1
Correlation of glucose between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Phosphate
Time Frame: Day 1
Correlation of phosphate between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Urate
Time Frame: Day 1
Correlation of urate between venipuncture and Tasso+™/SST samples for each cohort
Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for C-reactive Protein
Time Frame: Day 1
Correlation of C-reactive protein between venipuncture and Tasso+™/SST samples for each cohort
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Evaluate Tasso+™ User Experience (Safety)
Time Frame: Within 7 days of Tasso+™ administration
Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration
Within 7 days of Tasso+™ administration
To Evaluate Tasso+™ User Experience (Safety)
Time Frame: Day 29
Percentage of eligible subjects who experienced unsolicited AEs within 28 days of Tasso+™ administration
Day 29
To Evaluate Tasso+™ User Experience (Safety)
Time Frame: Day 29
Percentage of eligible subjects who experienced a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study discontinuation, or a related SAE within 28 days of Tasso+™ administration
Day 29
To Evaluate Tasso+™ User Experience (Tolerability)
Time Frame: Day 57
Percentage of eligible participants who complete last Tasso+™ administration (Day 57)
Day 57
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 1
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Day 1
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 29
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Day 29
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 57
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Day 57
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 85
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Day 85
To Perform Surveillance for SARS-CoV-2 Infection
Time Frame: Day 1
Percentage of eligible participants with a positive nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) on Day 1
Day 1
To Perform Surveillance for SARS-CoV-2 Infection
Time Frame: Between Days 1 and 57
Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57
Between Days 1 and 57
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 29
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Day 29
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 57
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Day 57
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 1
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Day 1
To Evaluate Tasso+™ User Experience (Usability)
Time Frame: Day 85
Preferred method for future blood sampling was assessed by the participant completing the Tasso questionnaire
Day 85

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity
Time Frame: Day 57
Percentage of Tasso+™/SST samples collected that are with adequate volume and without moderate or gross hemolysis between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity
Time Frame: Day 57
Percentage of Tasso+™/EDTA samples collected that are with adequate volume and without moderate or gross hemolysis between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Reliability
Time Frame: Day 57
Percentage of Tasso+™ device failure between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Time Frame: Within 7 days of Tasso+™ administration on Day 57, up to a maximum of 64 days
Percentage of subjects with solicited local AEs within 7 days of Tasso+™ administration on Day 57 between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™
Within 7 days of Tasso+™ administration on Day 57, up to a maximum of 64 days
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Time Frame: Within 28 days of Tasso+™ administration on Day 57, up to Day 85
Percentage of subjects with unsolicited AEs, related Grade 3 AE, related Grade 4 AE, related AE leading to discontinuation, or related SAE within 28 days of Tasso+™ administration on between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Within 28 days of Tasso+™ administration on Day 57, up to Day 85
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Time Frame: Day 57
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Time Frame: Day 57
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alachua Government Services, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
ICON Government and Public Health Solutions, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5309/0024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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