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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Laderman, Ph.D. | Biomerica, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomerica, Inc. | Irvine | California | 92614 | United States |
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Serum, Plasma and Dried Blood Spots (DBS - whole blood dried on filter paper). Serum and Plasma will be retained the DBS will be depleted and not retained