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

Completed

Conditions studied: SARS-CoV2 Infection

In brief

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.

Key facts

Study ID

NCT05338762

Run by

MiCo BioMed Co., Ltd.

People needed

218

Starts

2021-06-02

Expected to finish

2022-08-03

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Mississippi State University — Starkville, Mississippi, United States
• Joy Internal Medicine — Englewood Cliffs, New Jersey, United States
• WellNow Urgent Care — Cincinnati, Ohio, United States
• WellNow Urgent Care — Columbus, Ohio, United States
• WellNow Urgent Care — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.