Clinical trial NCT04256694: Rapid Strep Test Results
Official title: Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Strept Throat
Keywords: Carrier rate
Rapid antigen test
Lead sponsor: Kendall Healthcare Group, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Florida International University
First posted: 2020-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, primarily from subjects known to the investigators.

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.

Eligibility criteria: Inclusion Criteria:

* Any person at least 18 years old

Exclusion Criteria:

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

Primary outcomes:
measure: % Positive Rapid Antigen Strep Tests
timeFrame: The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.
Secondary outcomes:
measure: Predictors of Positive Strep Tests
timeFrame: After enrollment of all subjects, a logistic regression analysis will be performed.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
Study officials:
affiliation: Kendall Healthcare Group, Ltd.
name: Tony Zitek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.