Specimen Collection Study Protocol
Completed
Conditions studied: Focus in on Collecting Paired Specimens for Matrix Equivalency
In brief
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.
Key facts
- Study ID
- NCT04468386
- Run by
- Biomerica
- People needed
- 47
- Starts
- 2020-07-07
- Expected to finish
- 2021-05-30
- Last updated by the study team
- 2021-11-24
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Biomerica, Inc. — Irvine, California, United States
Full record on ClinicalTrials.gov
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