SalivaDirect

Message

Fact Sheet for Health Care Providers:
SalivaDirect - Healthcare Provider Fact Sheet (fda.gov)
Fact Sheet for Patients:
SalivaDirect - Patient Fact Sheet (yale.edu)

Test Code

30089

Alias/See Also

COVID-19
SARS-CoV-2
Coronavirus

CPT Codes
U0004

Preferred Specimen

Saliva

Patient Preparation
For at least 30 minutes prior to collection:
DO NOT
1. eat or drink
2. smoke
3. clean your teeth
4. chew gum
5. use nasal sprays

Minimum Volume

0.5 mL

Instructions

Allow saliva to pool in mouth, and gently allow saliva to pass into the collection tube. Do this until the minimum volume has been acheived.
*avoid coughing or sniffing
*do not 'spit' into the container so that droplets and aerosols are minimized.

Transport Temperature

Room Temperature

Specimen Stability

5 Days

Methodology
RT-qPCR
SalivaDirect™ has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

FDA Status
EUA

Performed By
CoxHealth

Performing Laboratory
Cox South

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.