Status:
COMPLETED
Specimen Collection Study Protocol
Lead Sponsor:
Biomerica
Conditions:
Focus in on Collecting Paired Specimens for Matrix Equivalency
Eligibility:
All Genders
21+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- Aged 21 and older
- Able to read, speak, and understand English
- Must weigh a minimum of 110 pounds
- Willing and able to donate 20 mLs of whole blood via venipuncture. \[approximately ˂ 2 tablespoons\]
- Willing and able to donate 0.040 mLs of whole blood via fingerstick
- Willing and able to sign the informed consent (self or authorized representative)
- Willing and able to self-collect a nasal swab per the provided instruction shee
Exclusion
- Aged less than 21 years old
- Unable to provide consent.
- Unable to donate blood via venipuncture and fingerstick.
- Unable to self-collect a nasal swab
Key Trial Info
Start Date :
July 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04468386
Start Date
July 7 2020
End Date
May 30 2021
Last Update
November 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Biomerica, Inc.
Irvine, California, United States, 92614