UnknownNot Applicable

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

United States315 participantsStarted 2011-12

Plain-language 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.

Who can participate

Age range3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Trial details

NCT IDNCT01491776

SponsorIND Diagnostic Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-03

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