Evaluation of the IND One Step Strep A Rapid Test vs. Culture
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 3 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2011 |
| End Date: | April 2012 |
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.
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.
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.
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.
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
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