COVID-19 Tests With Saliva Specimens

Paradigm Laboratories

Status: Unknown

Conditions: Covid19

Treatments: Other: Saliva collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04567953

PLRD202001

Details and patient eligibility

About

Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and

  • Is able to give informed consent
  • Is able to understand oral or written instructions, and
  • Is able to mentally and physically perform self-collection of saliva using the provided collection device.

Exclusion criteria

• • Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Employees of Paradigm lab and the assisted living facilities involved in the study
• Members of other vulnerable populations

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Saliva and NP paired specimen collection

Experimental group

Treatment:

Other: Saliva collection