COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability

COVID-19 Clinical Trial

Official title:

Over the Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Human Usability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584189
• Other study ID #: EDP-SOP-TNC-013
• Status: Completed
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: October 2022
• Source: MP Biomedicals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SARS-CoV-2 rapid antigen over the counter usability study.

Description:

Coronavirus disease (COVID-19) is a disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 is a β-coronavirus, which is enveloped non-segmented positive-sense RNA virus 2. It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough. On 11 March 2020, the COVID-19 outbreak was characterized as a pandemic by the WHO. Since then, over 70 million people worldwide have been infected with the virus with over 1.5 million deaths attributed to the virus5. Laboratory testing for SARS-CoV-2 is currently being performed to determine if an individual has active infection via detection of viral RNA or if an individual has an immune response to the virus from a previous infection via detection of antibodies.

Specimen collection is a crucial first step in the evaluation of an individual's SARS-CoV-2 infection status. The goal of this project is to evaluate human usability of a rapid SARS-CoV-2 antigen test for over the counter (OTC) use. Study subjects under EDP supervision, either in-person or via video conference, will collect and test anterior nasal swab samples. The Rapid SARS-CoV-2 Antigen Test collection and testing methodology is viewed as a convenient and inexpensive method to test clinical specimens for SARS-CoV-2 and OTC access will improve the availability of COVD-19 testing.

The COVID-19 Antigen Rapid Test Device detects SARS-CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen. During testing, the extracted antigens bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess colored particles are captured at the internal control zone. The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working. (See Appendix 1).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• The study population will include subjects from 2 years old to greater than 65 years old.

• Lay subjects who perform the test on themselves must be able to read, write, speak, and understand English or Spanish.

Exclusion Criteria:

• Participants who regularly use home diagnostic tests, such as glucose meters, will be excluded.

• Persons under 2 years of age will be excluded from participation.

• Persons under 14 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on themselves.

• Persons under 18 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on another qualified participant.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

Device:
• Rapid SARS-CoV-2 Antigen Test
Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.

Locations

Country	Name	City	State
United States	EDP Biotech Corporation	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
MP Biomedicals, LLC	EDP Biotech

Country where clinical trial is conducted

United States, 

References & Publications (3)

Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0. — View Citation

Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17. — View Citation

Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 Candidate Ag Test Self-collections	Lay subjects aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person.	One Hour
Primary	30 Candidate Ag Test Collections of Another	Lay subjects aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person	One Hour
Secondary	At Least One Enrollment of a Spanish Speaking Lay User	At least one lay subject aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person and/or at least one lay subject aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person.	One Hour

External Links

•   Johns Hopkins University Center for Health Security Website. 2020.
•   WHO. 2022