Covid19
Conditions
Brief summary
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.
Interventions
OTHERSaliva collection
Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva
Sponsors
Paradigm Laboratories LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical evaluation of saliva as specimen for COVID-19 molecular test | 1 hour | We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test. |
Countries
United States
Outcome results
None listed