Clinical Performance of the Checkable Medical At-Home Strep A Test

Completed

Conditions studied: Streptococcus Pyogenes Infection, Pharyngitis, Respiratory Tract Infections

In brief

The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by untrained lay persons to detect the presence of Group A Streptococcal antigens in throat swab specimens from individuals five years of age and older with signs and symptoms of pharyngitis, such as fever and sore throat.

Key facts

Study ID

NCT05107362

Run by

Checkable Medical Inc

People needed

1347

Starts

2021-12-21

Expected to finish

2023-07-10

Last updated by the study team

2023-07-12

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects seeking medical care for two or more of the following signs/symptoms of pharyngeal streptococcal infections:
• pharyngeal pain [with or without swallowing],
• tonsillar swelling with exudates,
• pharyngeal erythema,
• tender cervical lymphadenopathy,
• fever.
• Subjects who have not received antibiotic treatment within the past 14 days.
• Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study

You may not qualify if…

• Lay users who are accompanying patients are unwilling/unable to collect throat swab sample from a child or adult.

Where it is running

• Robertson Pediatrics — Beverly Hills, California, United States
• Angel Kids Pediatrics — Jacksonville, Florida, United States
• L&A Morales Health Care — Miami, Florida, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Waggoner Pediatrics — Clive, Iowa, United States
• WellNow Urgent Care and Research — Kalamazoo, Michigan, United States
• Axis Clinicals — Dilworth, Minnesota, United States
• Infinitive Bio Research — Edison, New Jersey, United States
• Twelve Corners Pediatrics — Rochester, New York, United States
• AFC Urgent Care — The Bronx, New York, United States
• Plains Clinical Research — Fargo, North Dakota, United States
• Trinity Health — Minot, North Dakota, United States
• WellNow Urgent Care and Research — Lorain, Ohio, United States
• WellNow Urgent Care and Research — Milford, Ohio, United States
• WellNow Urgent Care and Research — Troy, Ohio, United States
• AFC Urgent Care — Easley, South Carolina, United States
• Tribe Clinical Research — Greenville, South Carolina, United States
• MDFirst — Lancaster, South Carolina, United States
• Pediatric Associates — Houston, Texas, United States
• Santa Clara Family Clinic — Houston, Texas, United States
• Pediatric Center — Richmond, Texas, United States
• North Houston Internal Medicine and Pediatric Clinic — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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