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Rapid Strep Test Results

Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04256694
Enrollment
200
Registered
2020-02-05
Start date
2020-02-05
Completion date
2021-04-30
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strept Throat

Keywords

Carrier rate, Rapid antigen test

Brief summary

This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults

Detailed description

The Unites States recommends the use of rapid antigen tests, but a number of other countries do not, citing a high prevalence of streptococcal carriers and only moderate sensitivity of rapid antigen tests \[1\]. Indeed, to fully understand when rapid antigen tests should be used, we need to know the streptococcal carrier rate for adults in the United States. Although there is a fair amount of data in this regard for children \[2,3\], the only study to report this value for adults was from over 20 years ago and was from Sweden \[4\]. That studied reported a Group A Streptococcus (GAS) carrier rate of 2.4-3.7% in healthy adults. Given how many patients seek medical care for sore throats that may potentially be streptococcal pharyngitis, the investigators believe more data about the GAS carrier rate and the rate of false positive rapid antigen tests is necessary. Thus, the investigators propose a prospective study to evaluate the rate of positive rapid antigen tests in healthy adult patients in our community. The investigators will perform rapid antigen tests for GAS on healthy adult subjects without any symptoms. Consenting patients will fill out a brief data collection form about their medical history, and an investigator will perform a rapid antigen throat swab to assess for GAS. The results of the rapid antigen test will be recorded, and a logistic regression analysis will be performed to determine if certain factors within the subject's medical history are predictive of positive rapid strep tests.

Interventions

DIAGNOSTIC_TESTRapid Antigen Test for Group A Streptococcus

Rapid strep tests will be performed by throat swab of healthy adult volunteers.

Sponsors

Florida International University
CollaboratorOTHER
Kendall Healthcare Group, Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Any person at least 18 years old

Exclusion criteria

* pregnant * prisoners * currently taking antibiotics * any acute symptoms

Design outcomes

Primary

MeasureTime frameDescription
% Positive Rapid Antigen Strep TestsThe throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.% of positive rapid antigen strep tests amongst all volunteers

Secondary

MeasureTime frameDescription
Predictors of Positive Strep TestsAfter enrollment of all subjects, a logistic regression analysis will be performed.Logistic regression analysis will assess if any of the following are significant predictors of positive strep tests: age, gender, race/ethnicity, chronic medical problems, whether or not the patient has had antibiotics within last month, whether or not they have a history of strep throat, and whether or not they are a medical student or healthcare professional.

Countries

United States

Contacts

Primary ContactTony Zitek, MD
zitek10@gmail.com305-480-6602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026