TekiTrust Tests to Determine the Level of SARS-COV-2/COVID-19 Neutralizing Antibodies in the Blood

SARS-CoV2 Infection Clinical Trial

Official title:

Clinical Agreement Study of 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit' and 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection Rapid Test'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338762
• Other study ID #: MIC-US-2021-001
• Status: Completed
• Start date: June 2, 2021
• Est. completion date: August 3, 2022

Study information

• Verified date: August 2022
• Source: MiCo BioMed Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test.

When a person has COVID-19 they develop antibodies to the virus which are contained in their blood stream. After a certain period, the number of antibodies to fight (neutralize) the virus begin to decrease. One common way to measure the amount of antibodies in the blood is to use a test called the PRNT. The focus of this study is to compare the ability of the TekiTrust ELISA Kit and the TekiTrust Rapid Test with the PRNT to determine if these tests can measure the antibodies equally well.

Description:

Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fingerstick sample will be obtained from the participant and for subjects with a positive test and symptom onset of less than 30 days a repeat RT-PCR nasal pharyngeal swab sample will be taken. The fingerstick sample will be used onsite by qualified site staff to test the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test. These results will be compared to the whole blood sample sent to the lab which will be analysed for SARS CoV-2 neutralizing antibodies using the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and the comparator Plaque Reduction Neutralization Test (PRNT) test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 3, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age

2. Able and willing to provide written informed consent

3. Previously diagnosed as SARS-CoV-2 positive by any FDA EUA approved assay with a symptom onset date within the previous 30 days and who are willing to provide a nasopharyngeal swab for RT-PCR testing

4. Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing

5. Previously diagnosed as SARS-CoV-2 positive by a FDA EUA approved RT-PCR assay with a symptom onset date greater than 30 days and a known date of PCR sample collection and symptom severity

Exclusion Criteria:

1. Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Locations

Country	Name	City	State
United States	WellNow Urgent Care	Cincinnati	Ohio
United States	WellNow Urgent Care	Columbus	Ohio
United States	WellNow Urgent Care	Dayton	Ohio
United States	Joy Internal Medicine	Englewood Cliffs	New Jersey
United States	Mississippi State University	Starkville	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
MiCo BioMed Co., Ltd.	Syntactx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.	PPA (Sensitivity) between =87% with a lower bound of the 95% confidence interval greater than 74.4%; NPA (Specificity) = 93% with a lower bound of the 95% confidence interval greater than 87.8%	Day one
Secondary	Safety endpoint: adverse events	Number of adverse events related to blood sample testing in tested participants.	Single study visit