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

• Conditions: Strep Throat

• Registration Number: NCT01491776
• Lead Sponsor: IND Diagnostic Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 315

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Pioneer Clinical Research, LLC; 🇺🇸 Bellevue, Nebraska, United States

HCCA Clinical Research; 🇺🇸 Smyrna, Tennessee, United States