Clinical trial NCT05338762: TekiTrust Tests to Determine the Level of SARS-COV-2/COVID-19 Neutralizing Antibodies in the Blood
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'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Keywords: Antibodies, Neutralizing
COVID-19
Lead sponsor: MiCo BioMed Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2022-04-21
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.
timeFrame: Day one
Secondary outcomes:
measure: Safety endpoint: adverse events
timeFrame: Single study visit
Other outcomes:
Locations:
city: Starkville
country: United States
facility: Mississippi State University
state: Mississippi
city: Englewood Cliffs
country: United States
facility: Joy Internal Medicine
state: New Jersey
city: Cincinnati
country: United States
facility: WellNow Urgent Care
state: Ohio
city: Columbus
country: United States
facility: WellNow Urgent Care
state: Ohio
city: Dayton
country: United States
facility: WellNow Urgent Care
state: Ohio
Study officials:
affiliation: MiCo BioMed
name: Jay Hahn, PhD
role: STUDY_DIRECTOR
References: