Clinical Performance of the Checkable Medical At-Home Strep A Test
1 other identifier
observational
1,347
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 4, 2021
CompletedStudy Start
First participant enrolled
December 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2023
CompletedJuly 12, 2023
March 1, 2023
1.6 years
October 25, 2021
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Sensitivity and Clinical Specificity
Sensitivity is the proportion of subjects with a positive bacterial culture that are also positive in the investigational Strep A test (+). Specificity is the proportion of subjects with a negative bacterial culture that are also negative in the investigational Strep A test (-).
1 day
Secondary Outcomes (1)
Negative Predictive Value
1 day
Study Arms (1)
Symptomatic Adult and Pediatric Subjects
Untrained lay user to collect throat swab specimen and perform investigational test.
Interventions
Untrained lay users (parents/guardians of pediatric subjects or friends/family members of adult subjects) collect throat swab specimens and perform the investigational diagnostic test.
Eligibility Criteria
A total of 610 to 1,220 male and female subjects in the US, with approximately 183 subjects being strep positive, are expected to participate in the study. At least half of the subjects will be between 5 and 17 years of age and the remaining subjects will be adults 18 years of age and older.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Checkable Medical Inclead
- Curebase Inc.collaborator
Study Sites (22)
Robertson Pediatrics
Beverly Hills, California, 90211, United States
Angel Kids Pediatrics
Jacksonville, Florida, 32225, United States
L&A Morales Health Care
Miami, Florida, 33142, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Waggoner Pediatrics
Clive, Iowa, 50325, United States
WellNow Urgent Care and Research
Kalamazoo, Michigan, 49048, United States
Axis Clinicals
Dilworth, Minnesota, 56529, United States
Infinitive Bio Research
Edison, New Jersey, 08817, United States
Twelve Corners Pediatrics
Rochester, New York, 14618, United States
AFC Urgent Care
The Bronx, New York, 10465, United States
Plains Clinical Research
Fargo, North Dakota, 58104, United States
Trinity Health
Minot, North Dakota, 58701, United States
WellNow Urgent Care and Research
Lorain, Ohio, 44053, United States
WellNow Urgent Care and Research
Milford, Ohio, 45150, United States
WellNow Urgent Care and Research
Troy, Ohio, 45373, United States
AFC Urgent Care
Easley, South Carolina, 29640, United States
Tribe Clinical Research
Greenville, South Carolina, 29607, United States
MDFirst
Lancaster, South Carolina, 29720, United States
Pediatric Associates
Houston, Texas, 77087, United States
Santa Clara Family Clinic
Houston, Texas, 77087, United States
Pediatric Center
Richmond, Texas, 77469, United States
North Houston Internal Medicine and Pediatric Clinic
Tomball, Texas, 77375, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marla McIntyre
Checkable Medical
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 4, 2021
Study Start
December 21, 2021
Primary Completion
July 10, 2023
Study Completion
July 10, 2023
Last Updated
July 12, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share