Coronavirus(COVID-19)PCR LSA

Message

Performed at BUMCT

Test Code

COVID19 LSA

CPT Codes
87635

Preferred Specimen

Nasopharyngeal (NP) Flexible Minitip Flocked swab collected in Universal Transport Media (UTM), Viral Transport Media (VTM), sterile saline, or liquid Amie’s media.

Minimum Volume

0.5mL

Other Acceptable Specimens

Oropharyngeal (OP) swab collected in Universal Transport Media (UTM), Viral Transport Media (VTM), sterile saline, or liquid Amie’s media. Lower respiratory specimens, including sputum, endotracheal aspirate, bronchoalveolar lavage.

Transport Temperature

Refrigerated

Methodology
RT-PCR

Setup Schedule

Run Daily

Report Available

24 hours (may be longer if demand increases)

Clinical Significance

This test is a qualitative nucleic acid in vitro diagnostic test for detection of SARS-CoV-2 (COVID-19). This test was developed, and its performance characteristics determined by Banner Health/Laboratory Sciences of Arizona in the Banner – University Medical Center Tucson Molecular Microbiology Laboratory. This test has not been FDA cleared or approved. This test is currently undergoing authorization by the FDA under an EUA for use by authorized laboratories approved under CLIA for high complexity testing. Once authorized by the FDA, this test will only be 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.

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.