COVID 19 BY NAA

Test Code

LAB7323

CPT Codes
87635

Includes

Detection of COVID-19 viral RNA

Preferred Specimen

Request swab from lab.

Patient Preparation
To collect a nasal swab sample, cafefully insert the swab into the nostril exhibiting the most visible drainage or the nostril that is most congested if drainage is not visible. Usine gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one ince into the nostril). Rotate the swab several times against the nasal wall then slowly remove from the nostril. Using the same swab, repeat sample collection in the other nostril.

Other Acceptable Specimens

Sterile Foam Tipped Swab

Transport Temperature

Room Temperature

Specimen Stability

15-30°C up to 1 hour

If greater than 1 hour delay occurs, dispose of sample. A new specimen must be collected for testing.

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Samples greater than 1 hour from collection will not be accepted for testing.

Methodology
Isothermal Nucleic Acid Amplification (NAAT)

Setup Schedule

DAILY, as received

Report Available

STAT: <60 minutes

Reference Range

Negative

Clinical Significance

Negative results do not preclude SARS-Co-V-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

This test has not been FDA cleared or approved. This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This test has been authorized only for 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 the emergency use of in vitro diagnostic tests for the detection of SARS-Co-V2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Performing Laboratory
Mount Sinai Hospital
Holy Cross Hospital

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.