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

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107362
• Other study ID #: CM-003
• Status: Completed
• Start date: December 21, 2021
• Est. completion date: July 10, 2023

Study information

• Verified date: March 2023
• Source: Checkable Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1347
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pharyngitis
• Respiratory Tract Infections
• Streptococcus Pyogenes Infection

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Checkable Medical Inc	Curebase Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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