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

March 7, 2012 updated by: IND Diagnostic Inc.

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Recruiting
        • Pioneer Clinical Research, LLC
        • Contact:
        • Principal Investigator:
          • Darin M. Gregory, MD
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • HCCA Clinical Research
        • Contact:
        • Principal Investigator:
          • Sreedhar (Steve) Samudrala, MD
      • Smyrna, Tennessee, United States, 37067
        • Recruiting
        • HCCA Clinical Research
        • Contact:
        • Principal Investigator:
          • Sadia Dar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects, 3 years of age or older, exhibiting symptoms consistent with Strep A infection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IND Diagnostic Inc.

Investigators

  • Principal Investigator: Darin M. Gregory, MD, Pioneer Clinical Research
  • Principal Investigator: Sadia Dar, MD, HCCA Clinical Research
  • Principal Investigator: Sreedhar (Steve) Samudrala, MD, HCCA Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND-CSP-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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