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

IND Diagnostic

Status: Unknown

Conditions: Strep Throat

Study type: Observational

Funder types: Industry

Identifiers

NCT01491776

IND-CSP-2011-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 315 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: No 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