Influenza and SARS COV-2 (FLUSC2) Virus Multiplex

Brief Description

This real-time RT-PCR assay is intended for the qualitative detection and differentiation of SARS-CoV-2, Influenza A, and/or Influenza B viral nucleic acid in clinical specimens collected from patients suspected of having COVID-19 and/or influenza (criteria includes clinical and/or epidemiological criteria). GPHL performs this real-time RT-PCR assay only under the Food and Drug Administration’s Emergency Use Authorization. This test will reflex to the appropriate Influenza characterization panel if Influenza A and/or B RNA is detected. 

Laboratory Unit

Molecular Biology

Methodology

RT-PCR

Specimen Collection

  • Nasopharyngeal (NP) swab:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Oropharyngeal (OP) swab:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Anterior nasal swab:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Sputum:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Bronchoalveolar lavage:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Lower respiratory tract aspirate:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Nasopharyngeal aspirate:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • Nasal aspirate:
    • Collect using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Place in 3-4 ml of appropriate transport media, such as viral transport media (VTM).
  • CDC reference: https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html

Storage/Transport

  • Nasopharyngeal (NP) swab can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Nasopharyngeal (NP) swab should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Oropharyngeal (OP) swab can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Oropharyngeal (OP) swab should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Anterior nasal swab can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Anterior nasal swab should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Sputum can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Sputum should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Bronchoalveolar lavage can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Bronchoalveolar lavage should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Lower respiratory tract aspirate can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Lower respiratory tract aspirate should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Nasopharyngeal aspirate can be maintained at refrigerated temperature (2-8°C) during overnight transit.  
  • Nasopharyngeal aspirate should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Nasal aspirate can be maintained at refrigerated temperature (2-8°C) during overnight transit.
  • Nasal aspirate should be stored frozen (-70°C or colder) and shipped with dry ice if delay in testing or shipping is expected.
  • Download this pdf file. FRM-QA 4 Refrigeration Outfit Guide

Acceptable Specimen Type(s)

  • Nasopharyngeal (NP) swab
  • Oropharyngeal (OP) swab
  • Anterior nasal swab
  • Sputum
  • Lower respiratory tract aspirate
  • Nasopharyngeal aspirate
  • Nasal aspirate

Test Request

Possible Results

  • Positive
  • Negative
  • Unsatisfactory
  • Invalid

Reference Range

Negative

Unacceptable Conditions

  • Missing testing requisition
  • Missing minimum of 2 patient identifiers
  • Improper labeling
  • Specimen leaked, damaged, or crushed in transit
  • Improper storage/transport of specimen
  • No specimen received (empty collection tube).
  • Wrong specimen type
  • Calcium alginate swabs
  • Cotton swabs with wooden shafts

Interfering Substances

N/A

Result Reported

1-3 business days

Turnaround times may be affected by the scale of the event.

Fees

No charge

LOINC/Order Codes

54932-9 (Order code: CT031300)95422-2 (Order code:433000)