Specimen Collection Study Protocol

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.

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Key information

Conditions

Focus in on Collecting Paired Specimens for Matrix Equivalency

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Biomerica, Inc.

Irvine, California, 92614, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Matrix Equivalency

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biomerica

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jul 13, 2020
Registry last updated: Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.