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Test Code LAB3702 COVID-19 Qualitative PCR

Important Note

  • NP, MT, or Anterior nasal swabs and tracheal aspirate samples received at SCH Main Campus by 11am, Sunday - Friday will have same day results in EPIC.
  • Endotracheal tube (ETT), sputum, BAL, and NP wash samples will have results in EPIC within 48 - 72 hrs.  Testing will be performed at University of Washington, Department of Laboratory Medicine.
  • If there is an add-on procedure, or next day procedure - please order the RAPID COVID PCR test.
  • Urgent care clinics are supporting pre-procedure and community testing.  Patients will have results in EPIC same day if samples received at SCH Main Campus by 11am, Monday - Sunday.

NOTE: COVID swabs in UTM can be sent through the pneumatic tube system. Please double bag all COVID swabs in UTM to prevent specimen leakage leading to tube system shutdown.

Infectious

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