ClinicalTrials.gg
CompletedNCT01441479Updated Feb 7, 2013

Strep A Fluorescent Immunoassay and Analyzer Field Study

An observational study in Strep Throat, sponsored by Quidel Corporation. Completed at 7 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2013-02-07.

Sponsored by Quidel Corporation · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
1,282
Ages
3 Years and older
Sex
All
01

Study summary

The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.

02

Conditions studied

  • Strep Throat
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects must be greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.

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.

Inclusion criteria

  • Male and female subjects three (3) years of age or older

Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis

  • Extreme sore throat
  • Redness of the posterior pharyngeal wall
  • Difficulty Swallowing
  • Fever, >38.7C (100F) at presentation or within past 24 hours
  • Pharyngeal exudate
  • Tender cervical lymphadenopathy
  • Absence of cough or other upper respiratory symptoms

Exclusion criteria

Exclusion Criteria:

  • Subjects currently under treatment with antibiotics are not to be included in this study.
  • At clinical sites requiring , unable to understand and consent to participation; for minors this includes parent or legal guardian.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Time perspective
Prospective
Enrollment
1,282 participants (actual)

Interventions

  • DeviceIn Vitro Diagnostic Device aid in diagnosing
06

What researchers measure

Primary outcomes

  1. Streptococcus Group B identification

    The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.

    Time frame: Immediate

07

Study locations

7 sites
  • Best Medical Group
    Phoenix, Arizona 85042, United States
  • La Costa Pediatrics
    Carlsbad, California 92009, United States
  • La Jolla Pediatrics
    San Diego, California 92121, United States
  • Teena Hughes
    Tampa, Florida 33613, United States
  • FastER Urgent Care
    Morris Plains, New Jersey 07950, United States
  • Twelve Corners Pediatrics
    Rochester, New York 14618, United States
  • Advanced Pediatrics
    Vienna, Virginia 22180, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2011
First posted
Sep 27, 2011
Start
Jun 2011
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
Feb 7, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01441479
Lead sponsor
Quidel Corporation
Responsible party
Sponsor
First posted
Sep 27, 2011
Start date
Jun 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 7, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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