Specimen Collection Study Protocol

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

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.

Study Overview

• Status: Completed
• Conditions: Focus in on Collecting Paired Specimens for Matrix Equivalency

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

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92614
      • Biomerica, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Biomerica
• Investigators: Principal Investigator: Elisabeth Laderman, Ph.D., Biomerica, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CV19-Col-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No