Test Code LAB3702 COVID-19 Qualitative PCR
Clinical System Name
COVID-19 Qualitative PCR
Synonyms
SARS-CoV-2
2019-nCoV
COVID
COVID-19
PUI nCoV
SARS
SARS-CoV-2
Wuhan Coronavirus
nCoV
Sample Requirements
Specimen: Nasopharyngeal (NP), mid-turbinate (MT), anterior nasal swabs. Tracheal aspirate.
Container(s): Upper respiratory specimens- Swab(s) in Universal Transport Media (UTM).
Tracheal aspirate- Sterile container.
It is preferred to have a dedicated swab for this test; however, sharing with other virology testing (e.g., RapidFlu, RapidViru, RapidBact, ARapidPnl) is allowed.
Nasophryngeal swabs and UTM are available on Demand Flow or through Central Supply.
Collection: Please consult Photo Swab Guide to determine which swab to collect.
Processing Instructions
Reject due to:
Spin: N
Aliquot: N
Temp: 2-8 C
Storage Location: CPA 1 Refrigerator, COVID Micro Rack
Off-site Collection: Refrigerate swabs in UTM for up to 3 days. If holding specimens more than 3 days, freeze at -70 C and transport frozen to the Main Lab. Tracheal aspirate specimens should be transported refrigerated to Main Lab as soon as possible.
Stability
Specimen Type | Temperature | Time |
Upper respiratory swabs in UTM | Room Temp |
≤ 48 hours |
Refrigerated |
≤ 3 days |
|
Frozen (-70 C) |
≤ 30 days |
|
Tracheal aspirate in sterile container | Room temp | 2 hours |
Refrigerated | 24 hours | |
Frozen | N |
Performing Laboratory
Seattle Children's Hospital
Department
Department: Microbiology Lab at SCH
Phone Number: (206) 987-2585
Methodology
Method for Nasopharyngeal (NP), mid-turbinate (midT), and anterior nasal swabs:
SCH Microbiology Laboratory employs Roche's FDA-cleared SARS-CoV-2 QL assay on the cobas 6800. This assay utilizes two targets: the ORF1 a/b gene that is unique to SARS-CoV-2 (Target 1) and a conserved region in the structural protein envelope E-gene for pan-Sarbecovirus detection, which is inclusive of SARS-CoV-2 (Target 2).
Amplification of both targets, or Target 1 alone, is interpreted as a result of “SARS-CoV-2 Detected”, while amplification of neither is interpreted as “SARS-CoV-2 Not Detected”. In cases where amplification is only observed for Target 2, the result is a presumptive “SARS-CoV-2 Detected”. While other Sarbecoviruses may serve as targets for amplification of Target 2, the only Sarbecovirus known to currently infect humans is SARS-CoV-2. Additional testing will be needed for these results if SARS-CoV or an as-yet-unknown Sarbecovirus is suspected.
Tracheal aspirate has not been cleared by the FDA, but have been validated, demonstrating performance characteristics acceptable by SCH Microbiology Lab.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Analytical Volume: 1 NP/MT/Nasal Swab in UTM