SARS-CoV-2 (COVID-19) Qualitative Rapid PCR (special approval only)

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General Information

Lab Name
SARS-CoV-2 (COVID-19) Qualitative Rapid PCR
Lab Code
NCVRPD
Epic Ordering
SARS-CoV-2 (COVID-19) Qualitative Rapid PCR
Description

This test provides rapid detection of SARS-CoV-2 (COVID-19) in clinically urgent settings by approval only.

Testing is performed by one of two methods:

The DiaSorin Molecular Simplexa™ COVID-19 Direct real-time RT-PCR assay targets two different regions of the SARS-CoV-2 (the causative agent for COVID-19) genome, ORF1ab and S gene. Amplification of either or both regions is a positive (detectable) result.

The Cepheid Emergency Use Authorization (EUA) SARS-CoV-2 Real-time RT-PCR assay targets 2 regions of SARS-CoV-2 RNA (the causative agent of COVID-19). Amplification of both the N2 and E targets or just the N2 nucleic acid target is considered positive. Detection of just the E nucleic acid target is considered a presumptive positive result and additional confirmatory testing may be needed.

See SARS-CoV-2 (COVID-19) Qualitative PCR [NCVQLT] for interpretive details.

Testing supplies are very limited. Use is limited to the following areas:

  • Inpatients requiring urgent (<8hrs) pre-operative/pre-procedural screening prior to aerosol generating procedures (AGP).
  • Patients who have arrived for a same day procedure (AGP) who did not have testing within the 3 days previous to the day of procedure, or developed new symptoms since the last COVID-19 test.
  • OB cases
  • Symptomatic patients being admitted.
  • Can also be considered for
    • HMC psych admits
    • Solid organ transplant admits
    • patients with no history who cannot give history/overdoses.


For all locations

  • Hand-deliver (do not tube) specimens to performing lab locations specified below.
  • Refer to the specimen collection guidelines
  • Instrument run time = 75 minutes + setup and resulting. Time to result will vary depending on testing volume.
  • POSITIVE results will be called to the ordering provider, negative results will not be called.

UWMC-Montlake

  • TO ORDER: Ordering provider or RN must contact Clinical Microbiology (206-598-6147) to arrange the order. Please provide the following information:
    • Patient's name and MRN
    • Tube number for the patient's nursing station
    • Ordering physician's first and last name
  • Lab will tube a special requisition slip to the ordering location.
  • Fill out the requisition completely and hand deliver the collected NP specimen to Clinical Microbiology, NW177.

Testing performed every 2hrs on the even hour, 24/7.

UWMC-Northwest

  • Orders for rapid COVID-19 testing can be placed in Soarian and PulseCheck.
  • The clinical indication field is required when ordering the test.
  • Testing can only be performed for the following indications:
    • Pre-op for urgent cases (i.e. sample available < 8-10 hours prior to case)
    • Patient discharging from ED to congregated facilities (students in dorms, homeless, rehab, etc)
    • All PUI admits in whom a negative rapid test would lead to prompt de-escalation of PPE.
    • Obstetric patients following OB/GYN guidelines (rapid testing for family members is not allowed).

Testing is performed every 2hrs on the even hour, 24/7.

The laboratory has the capacity for a maximum of 8 rapid tests every 2 hours. If required, testing will be prioritized based on clinical indication: 1. Preprocedural surveillance, 2. Symptomatic, 3. Admission surveillance, 4. Other asymptomatic, 5. Disease resolution. It is the responsibility of all providers who order rapid COVID-19 testing to order the test judiciously to ensure it is a resource for patients and the Infection Control indications that need it the most.


HMC

Goal: To use a rapid test as a PPE mitigation strategy, to decrease the movement of patients around the hospital during a rule out, and to facilitate AGPs without airborne precautions.

Symptomatic

  • Inpatients (including Psychiatry and Rehabilitation) with new symptoms consistent with COVID-19
  • Patients in the Psychiatric Emergency Department (PES)
  • Patients living homeless who will be discharged from the ER

Asymptomatic

  • Inpatients requiring urgent (≤ 12 hrs) pre-operative/pre-procedural screening prior to aerosol-generating procedures (AGP)
  • Inpatients to be discharged within 12 hrs to a SNF that requires COVID-19 testing
  • Patients to be enrolled in a research protocol that requires time-sensitive documentation of COVID-19

TO ORDER AT HMC:

  • The ordering provider will contact the COVID Operations Nurse to request COVID testing (COVID Ops RN to triage need for in-house rapid test vs. sent to UW Virology).
  • The COVID Ops RN will:
    • Write patient name, MRN, ordering physician, patient location, and indication on a requisition form.
    • Deliver requisition to the ordering floor either by hand or tube.
  • The specimen will be hand delivered to the lab with the requisition filled out.

Testing performed every 2hrs on the even hour, 24/7.

Synonyms
2019-nCoV, COVID, COVID-19, COVID19, PUI nCoV, SARS, SARS-CoV-2, Wuhan Coronavirus, nCoV
Components

Interpretation

Method

Real-time RT-PCR (DiaSorin Molecular Simplexa™ COVID-19 Direct kit or Cepheid Xpert SARS-CoV-2)

Reference Range
See individual components
Guidelines

Ordering & Collection

Specimen Type
nasopharyngeal (NP) swab, nasal (anterior nares) swab
Collection

Instructions for Nasopharyngeal Swab: Gently insert mini-tipped flocked nasopharyngeal swab (swab on flexible plastic shaft) through the nostril and into the nasopharynx, reaching the posterior nasopharynx. Leave swab in place for 2-3 seconds then rotate completely around for 10-15 seconds. Remove swab and repeat the same process in the other nostril with the same swab.

After the second swab is completed, immediately place into the sterile vial containing media (UTM/VTM is preferred; saline is acceptible). Make sure that the swab is fully immersed in media, and that the shaft is short enough to completely tighten the cap. Obtaining columnar epithelial cells will enhance reliability of viral detection.

Tubes containing phosphate buffered saline (PBS) will be rejected. These include red-top Greiner "VACUETTE® Virus Stabilization Tubes." Specimens in PBS may be acceptable for the routine COVID-19 PCR test in the Virology laboratory.

Approval Required
Approval required - see instructions
Handling Instructions

See description above

Processing

Processing

All processing is done at the performing location.

Performance

LIS Dept Code
Virology, Eastlake (EVIR)
Performing Location(s)
HMC Microbiology
UW-NW Main Lab
UW-MT Microbiology
Frequency
See test information for schedule at each hospital
Available STAT?
Yes, with approval

Billing & Coding

CPT codes
87635
LOINC
94531-1
Regulatory Category
FDA-Cleared/Approved