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Trial Outcomes & Findings for Tasso-SST OnDemand Comparator Pilot Study (NCT NCT04713748)

NCT ID: NCT04713748

Last Updated: 2022-07-28

Results Overview

Sensitivity is defined as the number detected as positive on the new screen (Tasso) divided by the number defined as positive under the 'gold standard' multiplied by 100%. This is presented as a comparison to testing of blood samples obtained by routine phlebotomy as the gold standard (Abbott Alinity nucleocapsid IgG antibody assay drawn by a phlebotomist).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

135 participants

Primary outcome timeframe

up to 17 days after onset of symptoms

Results posted on

2022-07-28

Participant Flow

1. Recruitment into the Tasso Pilot Study occurred from 1/15/2021 to 3/10/2021. 2. All participants were recruited from tC3PI Study sub-cohort - had serial COVID-19 bimonthly antibody testing. 3. A total of 281 participants in the C3PI invited to participate. 4. 135 eligible individuals provided consent for the Tasso Pilot Study.

Participant milestones

Participant milestones
Measure
TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy
Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant.
Overall Study
STARTED
135
Overall Study
COMPLETED
100
Overall Study
NOT COMPLETED
35

Reasons for withdrawal

Reasons for withdrawal
Measure
TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy
Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant.
Overall Study
Not enough kits allocated
35

Baseline Characteristics

Tasso-SST OnDemand Comparator Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy
n=100 Participants
Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
67 Participants
n=5 Participants
Age, Categorical
>=65 years
33 Participants
n=5 Participants
Age, Continuous
59.5 years
n=5 Participants
Sex: Female, Male
Female
60 Participants
n=5 Participants
Sex: Female, Male
Male
40 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
93 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=5 Participants
Race (NIH/OMB)
White
85 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
100 Participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 17 days after onset of symptoms

Population: Participants who were able to draw blood using the TASSO-SST OnDemand device.

Sensitivity is defined as the number detected as positive on the new screen (Tasso) divided by the number defined as positive under the 'gold standard' multiplied by 100%. This is presented as a comparison to testing of blood samples obtained by routine phlebotomy as the gold standard (Abbott Alinity nucleocapsid IgG antibody assay drawn by a phlebotomist).

Outcome measures

Outcome measures
Measure
TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy
n=70 Participants
Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant.
Sensitivity is Calculated as the Percentage of the Abbott Alinity Nucleocapsid IgG Antibody Assay Positive Cases Testing Positive Using TASSO-SST Collected Blood Samples. Se=N Tasso(+) / N Phlebotomy Antibody (+) Assay (+)
100 percent sensitivity

PRIMARY outcome

Timeframe: up to 17 days after onset of symptoms

Population: Participants who were able to draw blood using the TASSO-SST OnDemand device.

Interclass correlation (ICC) uses the 2 measures (Tasso \& SST), measured on the same subjects. ICC is defined as the Variance between Persons (Var-P) divided by the Variance within Persons (error) Var-E. ICC is defined as Var-P/(Var-P + Var-E). confidence intervals are easily defined by incorporating sample size. Presented as the interclass correlation coefficient between TASSO-SST collected and routine phlebotomy sample results.

Outcome measures

Outcome measures
Measure
TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy
n=70 Participants
Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant.
Reliability of the Abbott Alinity Nucleocapsid IgG Antibody Assay Using TASSO-SST Collected Blood Samples
0.98 interclass correlation coefficient
Interval 0.97 to 0.99

PRIMARY outcome

Timeframe: up to 17 days after onset of symptoms

Population: Participants who were able to draw blood using the TASSO-SST OnDemand device.

Bias is measured using the Bland-Altman method. Here, the difference the values by the 2 measures (Phlebotomy-Tasso) (difference) is compared to the average of Phlebotomy \& Tasso (average). Bias is defined as differences which vary from 0, and is measured by (1) assessing if the average difference is non-zero, and (2) if the difference is systematically more or less close to 0 as the average increases. Presented as the regression slope.

Outcome measures

Outcome measures
Measure
TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy
n=70 Participants
Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant.
Bias Between TASSO-SST Collected Blood Samples and Routine Phlebotomy Samples in the Abbott Alinity Nucleocapsid IgG Antibody Assay
0.72 slope
Standard Deviation 1.42

Adverse Events

Definition of Arm/Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Douglas Wixted

Duke Clinical and Translational Science Institute

Phone: 919-668-0515

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place