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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01491776

Enrollment

315

Registered

2011-12-14

Start date

2011-12-31

Completion date

2012-04-30

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strep Throat

Keywords

Group A Streptococcus, Strep A, Rapid Test, Pharyngitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results