Clinical trial NCT05213897: Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings
Official title: Clinical Performance Evaluation of SARS-CoV-2 Antigen Assay in Point of Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Lead sponsor: Freedom For All Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: CSSi Life Sciences
First posted: 2022-01-28
Enrollment: 232
Sex: ALL
Minimum age (years): 2
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing symptoms and presenting for testing of Covid-19.

Brief summary: The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.

Detailed description: The objective of this study is to demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. This study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the SARS-CoV-2 Antigen Assay when non-laboratory personnel conduct testing on Subjects presenting with symptoms of COVID-19.

A minimum of 30 positive and 30 negative samples are required in order to meet EUA submission guidelines. Enrollment will continue until both minimum requirements have been achieved.

Eligibility criteria: Inclusion Criteria:

* Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following:

  * Fever or chills
  * Cough
  * Shortness of breath or difficulty breathing
  * Fatigue
  * Muscle or body aches
  * Headache
  * New loss of taste or smell
  * Sore throat
  * Congestion or runny nose
* In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study.
* Subject is willing to provide consent/assent.
* Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs

Exclusion Criteria:

To be enrolled in the study, each Subject must not meet:

* Subject unable or unwilling to provide informed consent/assent.
* Subject tested positive for SARS-CoV-2 within the past 3 months.
* Subject has already participated in this study.
* Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.

Primary outcomes:
measure: Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Elkridge
country: United States
facility: Centennial Medical
state: Maryland
Study officials:
affiliation: Centennial Medical Group
name: Steven Geller, MD
role: PRINCIPAL_INVESTIGATOR
References: