Clinical Performance of the Checkable Medical At-Home Strep A Test
Public ClinicalTrials.gov record NCT05107362. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05107362
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,347 participants
Conditions and interventions
Interventions
- untrained lay user performs investigational diagnostic test Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 5 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2021 (Actual)
- Primary completion
- Jul 10, 2023 (Actual)
- Completion
- Jul 10, 2023 (Actual)
- Last update posted
- Jul 12, 2023
2021 – 2023
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Robertson Pediatrics | Beverly Hills | California | 90211 | — |
| Angel Kids Pediatrics | Jacksonville | Florida | 32225 | — |
| L&A Morales Health Care | Miami | Florida | 33142 | — |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | — |
| Waggoner Pediatrics | Clive | Iowa | 50325 | — |
| WellNow Urgent Care and Research | Kalamazoo | Michigan | 49048 | — |
| Axis Clinicals | Dilworth | Minnesota | 56529 | — |
| Infinitive Bio Research | Edison | New Jersey | 08817 | — |
| Twelve Corners Pediatrics | Rochester | New York | 14618 | — |
| AFC Urgent Care | The Bronx | New York | 10465 | — |
| Plains Clinical Research | Fargo | North Dakota | 58104 | — |
| Trinity Health | Minot | North Dakota | 58701 | — |
| WellNow Urgent Care and Research | Lorain | Ohio | 44053 | — |
| WellNow Urgent Care and Research | Milford | Ohio | 45150 | — |
| WellNow Urgent Care and Research | Troy | Ohio | 45373 | — |
| AFC Urgent Care | Easley | South Carolina | 29640 | — |
| Tribe Clinical Research | Greenville | South Carolina | 29607 | — |
| MDFirst | Lancaster | South Carolina | 29720 | — |
| Pediatric Associates | Houston | Texas | 77087 | — |
| Santa Clara Family Clinic | Houston | Texas | 77087 | — |
| Pediatric Center | Richmond | Texas | 77469 | — |
| North Houston Internal Medicine and Pediatric Clinic | Tomball | Texas | 77375 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05107362, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 12, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05107362 live on ClinicalTrials.gov.