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Test Code COV19B SARS-CoV-2 Amplified

Important Note

Primary use of this test is reserved for Outpatient.

This test has received Emergency Use Authorization (EUA) by the FDA. See the Patient Fact Sheet for more information.

Infectious

Additional Codes

Epic: LAB3779

Indended Use

The Hologic SARS-CoV-2 amplified molecular test is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in nasopharyngeal swab submitted in Viral Transport Media (VTM) collected from individuals suspected of COVID-19 by their healhcare provider.

This test has received Emergency Use Authorization (EUA) by the FDA. See the Patient Fact Sheet for more information.

Specimen Requirements & Patient Preparation

Nasopharyngeal swab (NP) submitted in Viral Transport Media (VTM).

Nasopharyngeal swab (NP) submitted in Hologic Direct Load Collection Transport (Purple Top)

 

 

Methodology

Molecular

Hologic Aptima SARS-CoV-2 amplified assay on the Panther

Transcription Mediated Amplification (TMA)

 

 

Specimen Stability

VTM = Refrigerated up to 3 days

Hologic DL transport = Ambient 6 days.  Refrigerated 3 months.

 

Day(s) Test Set Up

Monday through Sunday.  All shifts

Turnaround Time

Results obtained usually within 24 hours after receipt of specimen in the laboratory under normal circumstances.  If repeat testing is needed, delays may result.

Rejection Criteria

Cotton Swabs

Wooden Shaft Swabs

Reference Values

Positive/Negative

CPT Coding

87635