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

NCT05338762 | Completed

• 1 other identifier: MIC-US-2021-001
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

SARS-CoV2 Infection

Keywords

Antibodies, Neutralizing; COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.

  1. PPA (Sensitivity) between ≥87% with a lower bound of the 95% confidence interval greater than 74.4% 2. NPA (Specificity) ≥ 93% with a lower bound of the 95% confidence interval greater than 87.8%

  Day one

Secondary Outcomes (1)

• Safety endpoint: adverse events

  Single study visit

Study Arms (2)

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: 1. 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 2. 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) 3. 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: 1. 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 2. 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 18 years of age
• Able and willing to provide written informed consent
• 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
• Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing
• 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

You may not qualify if:

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

Sponsors & Collaborators

• MiCo BioMed Co., Ltd.: lead
• Syntactx: collaborator

Study Sites (5)

Mississippi State University

Starkville, Mississippi, 39762, United States

Location

Joy Internal Medicine

Englewood Cliffs, New Jersey, 07632, United States

Location

WellNow Urgent Care

Cincinnati, Ohio, 45215, United States

Location

WellNow Urgent Care

Columbus, Ohio, 43214, United States

Location

WellNow Urgent Care

Dayton, Ohio, 45424, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jay Hahn, PhD

  MiCo BioMed

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: April 21, 2022
• Study Start: June 2, 2021
• Primary Completion: November 15, 2021
• Study Completion: August 3, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)