The DSHS Austin Laboratory Expands COVID-19 Testing Capabilities With The Aptima® SARS-CoV-2 Assay

DSHS Laboratory – Microbiological Sciences Branch Notice

Starting October 1, 2020, the DSHS Austin Laboratory will expand its COVID-19 testing capabilities by introducing the Aptima® SARS-CoV-2 Assay (Hologic Panther® system). This test is designed to detect the nucleic acid from SARS-CoV-2, the virus that causes COVID-19, in respiratory specimens. All current COVID-19 testing activities will continue and will not be affected by the addition of the new assay.

Specimens will not be tested without prior Epidemiologist (Epi) approval.  Contact your Regional and/or Local Health Department (https://www.dshs.texas.gov/regions/2019-nCoV-Local-Health-Entities/) and obtain Epi approval to test.

• Find specimen collection and submission instructions here

• Required Forms: G-2V Specimen Submission Form

• Acceptable specimen criteria:
  • NP, nasal and OP swab specimens in Viral Transport Medium (VTM), Universal Transport Medium (UTM), Liquid Amies, or 0.85% Saline.
  • Shipping Requirements
    • if DSHS receives within 3 days of collection ─ ship cold at +2-8°C
    • if DSHS receives > 3 days of collection ─ frozen/dry ice at -20°C or colder

• For further details regarding the Hologic, Inc. Aptima® SARS-CoV-2 assay, visit the FDA In Vitro Diagnostics EUAs for SARS-CoV-2 page: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

• Fact Sheet for Patients: https://www.fda.gov/media/138098/download

• Fact Sheet for Healthcare Providers: https://www.fda.gov/media/138095/download

For additional information and ongoing updates regarding the COVID-19 situation, please go to: https://www.dshs.texas.gov/coronavirus/ 

Email: coronavirus@dshs.texas.gov

DSHS COVID‑19 Call Center:  2-1-1 Option 6  Hours: 7:00 a.m. – 8:00 p.m., Monday – Friday