Rapid Strep Test Results

• Conditions: Strept Throat
• Interventions: Diagnostic Test: Rapid Antigen Test for Group A Streptococcus

• Registration Number: NCT04256694
• Lead Sponsor: Kendall Healthcare Group, Ltd.

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.

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study Start: 2020-02-05
• Study First Posted: 2020-02-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-03
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Any person at least 18 years old

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Adult Subjects	Rapid Antigen Test for Group A Streptococcus	-

Primary Outcome Measures

Name	Time	Method
% Positive Rapid Antigen Strep Tests	The 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 Outcome Measures

Name	Time	Method
Predictors of Positive Strep Tests	After 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.

Trial Locations

Locations (1)

Kendall Regional Medical Center; 🇺🇸 Miami, Florida, United States