Specimen Collection Study Protocol

NCT04468386 | Completed

• 1 other identifier: CV19-Col-004
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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 for in vitro diagnostic use only.

Conditions

Focus in on Collecting Paired Specimens for Matrix Equivalency

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Biomerica: lead

Study Sites (1)

Biomerica, Inc.

Irvine, California, 92614, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma and Dried Blood Spots (DBS - whole blood dried on filter paper). Serum and Plasma will be retained the DBS will be depleted and not retained

Study Officials

• Elisabeth Laderman, Ph.D.

  Biomerica, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: July 7, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: November 24, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)