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

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 Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Pharyngitis; Streptococcus Pyogenes Infection
• Intervention / Treatment: Diagnostic test: untrained lay user performs investigational diagnostic test

Detailed Description

The study is a prospective, consecutive, non-interventional multicenter study to evaluate the clinical performance of the Checkable Medical At-Home Strep A Test when the test is performed by non-trained adult lay users.

1. Patients or parents/legal guardians of patients presenting with signs and symptoms of pharyngeal GAS infections will be recruited at primary care or urgent care clinics.
2. Informed consent will be obtained from adult subjects and from the parents/guardians of pediatric subjects. Pediatric subjects 7 years of age or greater will be asked for their assent.
3. The lay user will be provided with a Checkable Medical At-Home Strep A Test kit. The user and patient will be provided with a quiet, private space where the user can collect the throat swab specimen and perform the investigational test.
4. Once the lay user has collected the swab sample for the Checkable Medical At-Home Strep A Test and performed the test, she/he will document the test result. The Checkable Medical At-Home Strep A Test result is not to be shared with members of the site team who are providing healthcare to the subject.
5. When all sample collection, testing and interpretation activities related to the investigational test are completed, a healthcare provider at the study site will collect two additional swab samples. One of these samples will be sent to a central lab where it will be cultured for GAS. An additional sample will be tested using the organization's standard of care (SOC) rapid Strep A test.
6. Subjects will be diagnosed and treated in accordance with routine SOC which may include an FDA-cleared rapid GAS test. The Checkable Medical At-Home Strep A Test will not be used to diagnose or treat study subjects.
7. This study will take place in at least six sites in at least three different regions of the United States.
8. The results from the Checkable Medical At-Home Strep A Test will be used to compare with the diagnostic truth obtained through culture to compute diagnostic accuracy parameters including sensitivity, NPV, specificity and PPV.

• Study Type: Observational
• Enrollment (Actual): 1347

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Robertson Pediatrics
  • Florida
    • Jacksonville, Florida, United States, 32225
      • Angel Kids Pediatrics
    • Miami, Florida, United States, 33142
      • L&A Morales Health Care
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
  • Iowa
    • Clive, Iowa, United States, 50325
      • Waggoner Pediatrics
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Wellnow Urgent Care and Research
  • Minnesota
    • Dilworth, Minnesota, United States, 56529
      • Axis Clinicals
  • New Jersey
    • Edison, New Jersey, United States, 08817
      • Infinitive Bio Research
  • New York
    • Bronx, New York, United States, 10465
      • AFC Urgent Care
    • Rochester, New York, United States, 14618
      • Twelve Corners Pediatrics
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research
    • Minot, North Dakota, United States, 58701
      • Trinity Health
  • Ohio
    • Lorain, Ohio, United States, 44053
      • Wellnow Urgent Care and Research
    • Milford, Ohio, United States, 45150
      • Wellnow Urgent Care and Research
    • Troy, Ohio, United States, 45373
      • Wellnow Urgent Care and Research
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • AFC Urgent Care
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research
    • Lancaster, South Carolina, United States, 29720
      • MDFirst
  • Texas
    • Houston, Texas, United States, 77087
      • Pediatric Associates
    • Houston, Texas, United States, 77087
      • Santa Clara Family Clinic
    • Richmond, Texas, United States, 77469
      • Pediatric Center
    • Tomball, Texas, United States, 77375
      • North Houston Internal Medicine and Pediatric Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. 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.
2. Subjects who have not received antibiotic treatment within the past 14 days.
3. Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic Adult and Pediatric Subjects; Untrained lay user to collect throat swab specimen and perform investigational test.	Diagnostic test: untrained lay user performs investigational diagnostic test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Predictive Value	Negative Predictive Value (NPV) is the proportion of subjects with negative investigational Strep A test results who also have negative cultures (diagnostic truth); calculated as 100 x d/(c+d).	1 day

Collaborators and Investigators

• Sponsor: Checkable Medical Inc
• Collaborators: Curebase Inc.
• Investigators: Study Director: Marla McIntyre, Checkable Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: In vitro diagnostic
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Infections; Communicable Diseases; Respiratory Tract Infections; Pharyngitis
• Other Study ID Numbers: CM-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No