Evaluation of Self-Collected Saliva Samples Without Viral Transport Media for SARS-CoV-2 Testing Via RT-PCR

This is a descriptive study that will attempt to validate the procedure for detecting SARS-CoV-2 on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen. Investigators will calculate the percent agreement and the 95% confidence intervals (ie, overall agreement, percent positive agreement, and percent negative agreement) between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard). Participants without usable results for both the saliva and nasopharyngeal methods will not be included in the analyses. Currently, DGMC uses both FDA Emergency Use Authorization systems interchangeably to test for SARS-CoV-2.

Using human volunteers to obtain positive and negative nasopharyngeal and saliva specimens of SARS-COV-2, this is a test validation study. It uses the Eppendorf Thermal Cycler PCR system to compare the test performance of saliva as a specimen to the standard nasopharyngeal specimen.

This protocol utilizes two different convenience samples of DGMC patients. Patients (i.e. inpatient, outpatients) with a positive COVID-19 test in the past 72 hours, and those who present for COVID-19 testing at DGMC and have negative results. Both groups of patients are willing to provide a saliva sample for COVID-19 testing within 72 hours. The populations will be comprised of active duty, DoD dependents, and retirees who are DGMC patients. This study will enroll at least 60 individuals. Only saliva samples from 30 participants with negative and 30 with positive NP results will be processed. The study will stop recruiting positive patients after obtaining the paired saliva and NP results from 30 participants who are COVID-19 positive by NP test. The study will stop actively recruiting negative patients after obtaining the paired saliva and NP results from 30 participants who are COVID-19 negative by NP test. More than 30 negative patients may be recruited in an attempt to capture 30 positive patients.

Recruitment efforts for positive patients will be conducted utilizing a HIPAA waiver to identify potential study participants, as well as, targeting patients exposed to and/or with symptoms related to COVID-19 who present for COVID-19 testing. The HIPAA Waiver will be used to identify patients (inpatient, outpatient) who have had a positive COVID-19 NP test within the past 72 hours. These patients, as well as others who will have COVID-19 testing at DGMC, will be informed of the study.

Patients interested in participation will make contact with study staff. Those eligible to participate will be given study documents (consent and HIPAA Authorization Form), that will later be reviewed and signed by the patient and study staff. Thereafter, additional information (contact, demographic), and a self-collected saliva specimen will be obtained.