Specimen Collection Study Protocol

Focus in on Collecting Paired Specimens for Matrix Equivalency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468386
• Other study ID #: CV19-Col-004
• Status: Completed
• Start date: July 7, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: July 2020
• Source: Biomerica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Focus in on Collecting Paired Specimens for Matrix Equivalency

Locations

Country	Name	City	State
United States	Biomerica, Inc.	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Biomerica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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