An observational study in Focus in on Collecting Paired Specimens for Matrix Equivalency, sponsored by Biomerica. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by Biomerica · Observational
The specimens collected will be used to evaluate matrix equivalency in an immunoassay in development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum. These reagents are for in vitro diagnostic use only.
The objective of this study is to acquire paired serum, plasma and whole blood collected on a collection card from subjects with no known history of COVID-19 infection. The specimens will be collected at Biomerica in Irvine CA for specimen collection, banking, and matrix equivalency studies for projects in development at Biomerica for detection to IgG or IgA or IgM antibodies to Sars-CoV2 antibodies. Subject will also be asked to self-collect a nasal swab for COVID-19 PCR
The study population will consist of subjects identified as meeting the inclusion/exclusion criteria from Biomerica employees and/or friends and family of Biomerica's employees. There will be no outside advertising or recruiting. All subjects must be willing to sign the informed consent and undergo the venipuncture and finger stick blood collection process and perform the nasal swab collection.
Exclusion Criteria:
Matrix Equivalency
This study is designed to collect specimens to support specimen matrix equivalency in an in vitro diagnostic assay for the detection of COVID-19 antibodies. Additionally, specimens collected via finger stick will be used to validate a whole blood collection card that could be used in the field by trained professionals and sent back to central reference laboratories for testing.
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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