COVID Clinical Trial
Official title:
Evaluation of Commerical Antibody Tests for COVID-19
NCT number | NCT04360954 |
Other study ID # | 202004088 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 23, 2020 |
Est. completion date | July 8, 2020 |
Verified date | June 2024 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to evaluate the sensitivity and specificity of several marketed commercial or prototype test kits for antibody to SARS-CoV-2. The focus will be on rapid-format, point-of-care antibody test kits that detect both IgM and IgG antibodies to recombinant viral proteins. Note: No voluntary enrolment into this study will be conducted; all testing is to be conducted anonymously.
Status | Completed |
Enrollment | 461 |
Est. completion date | July 8, 2020 |
Est. primary completion date | July 8, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Sera/plasma from patients who have been hospitalized and tested positive for SARS-CoV-2 - Sera/plasma from people who have recovered from COVID-19 - Sera/plasma from from healthy humans and persons with parasitic diseases Exclusion Criteria: - Persons under the age of 18 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, Sun R, Wang Y, Hu B, Chen W, Zhang Y, Wang J, Huang B, Lin Y, Yang J, Cai W, Wang X, Cheng J, Chen Z, Sun K, Pan W, Zhan Z, Chen L, Ye F. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Sep;92(9):1518-1524. doi: 10.1002/jmv.25727. Epub 2020 Apr 13. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test Sensitivity | Test sensitivity relative to RT-PCR for acute samples; sensitivity relative to ELISA for convalescent samples. | 2020 | |
Primary | Test Specificity | Percent positivity with pre-COVID samples | 2020 |
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