Rapid Strep Test Results

Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults

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

Study Overview

• Status: Unknown
• Conditions: Strept Throat
• Intervention / Treatment: Diagnostic test: Rapid Antigen Test for Group A Streptococcus

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33175
      • Recruiting
      • Kendall Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers, primarily from subjects known to the investigators.

Description

Inclusion Criteria:

• Any person at least 18 years old

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Adult Subjects	Diagnostic test: Rapid Antigen Test for Group A Streptococcus; Rapid strep tests will be performed by throat swab of healthy adult volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Positive Rapid Antigen Strep Tests	% of positive rapid antigen strep tests amongst all volunteers	The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of Positive Strep Tests	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.	After enrollment of all subjects, a logistic regression analysis will be performed.

Collaborators and Investigators

• Sponsor: Kendall Healthcare Group, Ltd.
• Collaborators: Florida International University

Publications and helpful links

General Publications

• Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med. 2007 Sep-Oct;5(5):436-43. doi: 10.1370/afm.741.
• Shaikh N, Leonard E, Martin JM. Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis. Pediatrics. 2010 Sep;126(3):e557-64. doi: 10.1542/peds.2009-2648. Epub 2010 Aug 9.
• Oliver J, Malliya Wadu E, Pierse N, Moreland NJ, Williamson DA, Baker MG. Group A Streptococcus pharyngitis and pharyngeal carriage: A meta-analysis. PLoS Negl Trop Dis. 2018 Mar 19;12(3):e0006335. doi: 10.1371/journal.pntd.0006335. eCollection 2018 Mar.
• Gunnarsson RK, Holm SE, Soderstrom M. The prevalence of beta-haemolytic streptococci in throat specimens from healthy children and adults. Implications for the clinical value of throat cultures. Scand J Prim Health Care. 1997 Sep;15(3):149-55. doi: 10.3109/02813439709018506.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2020
• Primary Completion (ANTICIPATED): April 30, 2021
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Carrier rate; Rapid antigen test
• Other Study ID Numbers: 108360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No