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 PCRNot 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 PCR – ABBOTT ASSAY)
U0005 (Conditional Charge-COVID-19 PCR ABBOTT ADD-ON )