Trial Outcomes & Findings for Diagnostic Performance of an Antigen Test for SARS-CoV-2 Infection (COVID-19) (NCT NCT04610489)

Results Overview

Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

117 participants

Primary outcome timeframe

1 day

Results posted on

2021-08-17

Participant milestones
Measure	Study Population All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
Overall Study STARTED	117
Overall Study COMPLETED	117
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Age data were not collected for this study

Baseline characteristics by cohort
Measure	Study Population n=117 Participants All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
Age, Customized Age	0 Participants Age data were not collected for this study
Sex/Gender, Customized Gender	0 Participants Gender data was not collected for this study
Region of Enrollment United States	117 participants n=117 Participants

Timeframe: 1 day

Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).

Outcome measures
Measure	Study Population n=117 Participants All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
Proportion of True Positives	0.750 proportion of true positives Interval 0.566 to 0.885

Timeframe: 1 day

Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).

Outcome measures
Measure	Study Population n=117 Participants All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
Proportion of True Negatives	0.988 proportion of true negatives Interval 0.936 to 1.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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