Evaluation of the IND One Step Strep A Rapid Test vs. Culture

Strep Throat Clinical Trial

Official title:

Evaluation of the IND One Step Strep A Rapid Test Versus Culture Using Clinical Throat Swab Samples From Patients With Suspected Strep A Infections, CLIA Waiver Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01491776
• Other study ID #: IND-CSP-2011-01
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2011
• Last updated: March 7, 2012
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2012
• Source: IND Diagnostic Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.

Description:

Group A Streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. The Strep A Rapid Test is a simple and rapid test which can detect Group A Streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. The IND Diagnostic Inc. Strep A Rapid Test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with Strep A antibody. The test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Male and Female subjects three (3) years of age or older

• Patients exhibiting at least 3 of the following symptoms:

• fever

• sore throat

• swollen lymph nodes in the neck

• redness of the throat and tonsils

• white or yellow patches on the tonsils

• Must be able to collect 2 throat swab samples from patient

Exclusion Criteria:

• Patients currently undergoing antibiotic treatment will be excluded from study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Strep Throat
• Streptococcal Infections

Locations

Country	Name	City	State
United States	Pioneer Clinical Research, LLC	Bellevue	Nebraska
United States	HCCA Clinical Research	Franklin	Tennessee
United States	HCCA Clinical Research	Smyrna	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
IND Diagnostic Inc.

Country where clinical trial is conducted

United States,