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,
Bogus J, Gankpala L, Fischer K, Krentel A, Weil GJ, Fischer PU, Kollie K, Bolay FK. Community Attitudes Toward Mass Drug Administration for Control and Elimination of Neglected Tropical Diseases After the 2014 Outbreak of Ebola Virus Disease in Lofa County, Liberia. Am J Trop Med Hyg. 2016 Mar;94(3):497-503. doi: 10.4269/ajtmh.15-0591. Epub 2015 Dec 14. — View Citation
Chesnais CB, Awaca-Uvon NP, Bolay FK, Boussinesq M, Fischer PU, Gankpala L, Meite A, Missamou F, Pion SD, Weil GJ. A multi-center field study of two point-of-care tests for circulating Wuchereria bancrofti antigenemia in Africa. PLoS Negl Trop Dis. 2017 Sep 11;11(9):e0005703. doi: 10.1371/journal.pntd.0005703. eCollection 2017 Sep. — View Citation
Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. Erratum In: Euro Surveill. 2020 Apr;25(14): Euro Surveill. 2020 Jul;25(30): Euro Surveill. 2021 Feb;26(5): — View Citation
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
Okba NMA, Muller MA, Li W, Wang C, GeurtsvanKessel CH, Corman VM, Lamers MM, Sikkema RS, de Bruin E, Chandler FD, Yazdanpanah Y, Le Hingrat Q, Descamps D, Houhou-Fidouh N, Reusken CBEM, Bosch BJ, Drosten C, Koopmans MPG, Haagmans BL. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease Patients. Emerg Infect Dis. 2020 Jul;26(7):1478-1488. doi: 10.3201/eid2607.200841. Epub 2020 Jun 21. — View Citation
Tang YW, Schmitz JE, Persing DH, Stratton CW. Laboratory Diagnosis of COVID-19: Current Issues and Challenges. J Clin Microbiol. 2020 May 26;58(6):e00512-20. doi: 10.1128/JCM.00512-20. Print 2020 May 26. — View Citation
Weil GJ, Curtis KC, Fakoli L, Fischer K, Gankpala L, Lammie PJ, Majewski AC, Pelletreau S, Won KY, Bolay FK, Fischer PU. Laboratory and field evaluation of a new rapid test for detecting Wuchereria bancrofti antigen in human blood. Am J Trop Med Hyg. 2013 Jul;89(1):11-15. doi: 10.4269/ajtmh.13-0089. Epub 2013 May 20. — View Citation
Weil GJ, Lammie PJ, Weiss N. The ICT Filariasis Test: A rapid-format antigen test for diagnosis of bancroftian filariasis. Parasitol Today. 1997 Oct;13(10):401-4. doi: 10.1016/s0169-4758(97)01130-7. — View Citation
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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