An observational study in Group A Streptococcus, sponsored by Quidel Corporation. Completed at 7 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2017-08-03.
Sponsored by Quidel Corporation · Observational
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.
Quidel Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from the general population as they present to the clinical facility. Subjects must be exhibiting symptoms characteristic of pharyngitis, possibly GAS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For example:
Other, symptoms specific to Strep A not listed above.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study.
Detection of Group A Streptococcus
A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer
Time frame: Within 5 minutes
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Quidel Corporation