Specimen Collection Study Protocol

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04468386

Enrollment

Registered

2020-07-13

Start date

2020-07-07

Completion date

2021-05-30

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus in on Collecting Paired Specimens for Matrix Equivalency

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results