NCT04468386

Specimen Collection Study Protocol

Specimen Collection Study Protocol; Internal Biomerica Normal Specimen Collection and Banking for Use in COVID-19 Serological Product Development

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Biomerica · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Focus in on Collecting Paired Specimens for Matrix Equivalency

Timeline

• Start date: 2020-07-07
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2020-07-13
• Last updated: 2021-11-24

Locations

1 site across 1 country: United States