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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Starkville, Mississippi, United States, 39762
      • Mississippi State University
  • New Jersey
    • Englewood Cliffs, New Jersey, United States, 07632
      • Joy Internal Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • WellNow Urgent Care
    • Columbus, Ohio, United States, 43214
      • WellNow Urgent Care
    • Dayton, Ohio, United States, 45424
      • WellNow Urgent Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. Participants who have been previously diagnosed with SARS-CoV-2 through any FDA Emergency Use Authorization (EUA) approved assays with symptom onset within the previous 30 days or who are suspected of SARS-CoV-2 infection and are tested with FDA EUA approved RT-PCR.
2. Participants who have previously been diagnosed with SARS-CoV-2 through an FDA EUA approved RT-PCR assay with recorded symptom onset date more than 30 days, from date of PCR sample collection.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Current COVID-19 symptoms or SARS-CoV-2 in the last 30 days with a positive RT-PCR test; 75 subjects will be enrolled who were diagnosed as SARS-CoV-2 with a positive RT-PCR nasal pharangeal test or are suspected of having a COVID-19 infection with symptom onset in the last 30 days. (Symptom onset 0-30 days) This group of subjects will receive: a fingerstick blood sample for a rapid test neutralizing antibody test to be done in the office with the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test; a blood draw which will be sent to the lab for neutralizing antibody testing with the TekiTrust SARS-CoV-2 Nuetralizing Antibody Detection ELISA Kit and the standard Plaque Reduction Neutralization Test (PRNT); a nasal-pharangeal RT-PCR test
Diagnosed with SARS-CoV-2 (COVID-19) in the past 3 months with a positive RT-PCR test; 30 subjects will be enrolled who have been diagnosed with COVID-19 in the past 3 months and had a prior positive RT-PCR nasal pharangeal test. (Symptom onsent 31-90 days) This group of subjects will receive: a fingerstick blood sample for a rapid test neutralizing antibody test to be done in the office with the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test; a blood draw which will be sent to the lab for neutralizing antibody testing with the TekiTrust SARS-CoV-2 Nuetralizing Antibody Detection ELISA Kit and the standard Plaque Reduction Neutralization Test (PRNT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint: adverse events	Number of adverse events related to blood sample testing in tested participants.	Single study visit

Collaborators and Investigators

• Sponsor: MiCo BioMed Co., Ltd.
• Collaborators: Syntactx
• Investigators: Study Director: Jay Hahn, PhD, MiCo BioMed

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Antibodies, Neutralizing
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MIC-US-2021-001

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: No
• product manufactured in and exported from the U.S.: No