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Specimen Collection Study Protocol

NCT ID: NCT04468386

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-05-30

Brief Summary

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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

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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

Conditions

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Focus in on Collecting Paired Specimens for Matrix Equivalency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biomerica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Laderman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Biomerica, Inc.

Locations

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Biomerica, Inc.

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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CV19-Col-004

Identifier Type: -

Identifier Source: org_study_id