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Test Code LAB9100 SARS COV-2

Performing Section

Microbiology

Purpose/Principle

The Cepheid® Xpert® SARS-CoV-2 Assay is an automated, multiplex, real-time RT (reverse transcriptase) PCR assay intended for the targeted in vitro qualitative detection of the SARS-CoV-2 viral RNA genome. The Xpert® SARS-CoV-2 assay is intended as an aid in the diagnosis of COVID-19 in patients with signs and symptoms of respiratory infection or specific clinical or epidemiological risk factors.

Special Collection Notes

Collect specimen according to standard operating procedure.

Specimen Type

-Swab:

Respiratory PCR Swab with UTM Media Nasopharyngeal Swab (Dacron or locked in Viral Transport, no dry swabs)

Mid-turbinate Swab: Mid-Turbinate Swab Collection Kit (in Viral Transport, no dry swabs)

 

-Nasopharyngeal aspirate, Tracheal aspirate and Bronchoalveolar Lavage:

Sterile screw capped container

Specimen Volume

Nasopharyngeal aspirate, Tracheal aspirate, Sputum, and Bronchoalveolar Lavage:
Preferred: 1.0mL
Minimum: 0.5mL

Processing Instructions

Store refrigerated and send sample on wet ice via courier. If transport is greater than 24 hours, freeze specimen at -20 to -70° Celsius, and then transport on dry ice.

Temperature

Refrigerated

Test Components

SARS COV-2 PCR
SARS COV-2 CN Value

Reference Range

SARS COV-2 PCR

Not Detected

 

SARS COV-2 CN Value

This component has no reference ranges

TAT

6 Hours

Sample Stability

Nasopharyngeal aspirate, Tracheal aspirate, Sputum, and Bronchoalveolar Lavage
Refrigerated: 72 hours

Additional Notes

Specimen will be rejected if on the incorrect swab or media.

Aliases

Coronavirus
Novel Coronavirus
COVID-19

CPT

87635
U0001
U0003 (Conditional Charge-COVID-19 PCRABBOTT ASSAY)
U0005 (Conditional Charge-COVID-19 PCR ABBOTT ADD-ON )