Specimen Collection Study Protocol

Completed

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

• Registration Number: NCT04468386
• Lead Sponsor: Biomerica

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.

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 Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-07
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Matrix Equivalency	1 day	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.

Trial Locations

Locations (1)

Biomerica, Inc.; 🇺🇸 Irvine, California, United States