Ordering Recommendations

A combination of nasopharyngeal and throat specimens is optimal for testing. Submit both swabs in the same tube of Viral Transport Medium. Sputum or BAL specimens are also acceptable.
If only 1 swab is available, nasopharyngeal only testing is acceptable. Throat specimens are not acceptable.

Test Includes

2019 Novel Coronavirus (SARS-CoV-2 (COVID-19)) RNA testing by PCR

Collect

M6 or M4 Viral Transport Medium,M4RT, M5, VTM (Viral transport medium), UTM (Universal testing medium),  Sterile Screw Cap Container

During the Pandemic additional sample collection containers: Phosphate buffered saline, Eswab (Liquid Amies) transport media


Nasopharyngeal Collection Video

Specimen Preparation

NASOPHARYNGEAL: Insert a flexible mini-tip swab through the nostril into the nasopharynx. Rotate gently and withdraw. Place swab into M6 or M4 Viral Transport Medium.
NASOPHARYNGEAL/OROPHARYNGEAL (THROAT): Insert a flexible mini-tip swab through the nostril into the nasopharynx. Rotate gently and withdraw. Place swab into Viral Transport Medium. With the second swab, swab both tonsillar areas, posterior pharynx and any areas of inflammation, ulceration, or exudation. Place swab into Viral Transport Media with the NP swab.
SPUTUM: Have patient cough deeply and collect entire specimen of expectorated sputum in a sterile screw-cap container without additives.  (0.5 mL minimum). Samples collected at clients should be mixed 1:1 with Viral transport media.
BAL: Collect specimen using aseptic technique and accepted methods. Submit 5.0 mL in a sterile screw-cap container without additives.  (0.5 mL minimum).
Samples collected at clients should be mixed 1:1 with Viral transport media.

Storage/Transport Temperature

Refrigerate

Unacceptable Conditions

Inappropriate specimen type (throat or nasal), inadequate volume, inappropriate transport device, leaking specimen.

Stability (from collection to initiation)

Ambient or Refrigerated Specimens in Viral Transport Medium (VTM): 72 hours
Specimens not in VTM:  24 hours
Frozen: 1 month

Remarks

SARS-CoV-2 (2019-nCoV) is the virus which causes the disease named "coronavirus disease 2019" (abbreviated "COVID-19").  This test utilizes CDC-developed target sequences for the detection of SARS-CoV-2 RNA in combined nasopharyngeal/throat swab specimens collected in Viral Transport Medium.

Performed

Monday-Sunday

Reported

Froedtert Inpatient and Emergency room: 6 hours
Outpatient: 24 hours

Methodology

Real Time Polymerase Chain Reaction (PCR) Amplification

Reference Interval

Not Detected

Interpretive Data

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.

This test is a CDC-developed real-time PCR assay intended for the qualitative detection of SARS-CoV-2 (COVID-19) nucleic acid.  This assay has Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for specimens collected from individuals who meet CDC criteria for SARS-CoV-2 testing.  Test performance characteristics were determined by the Wisconsin Diagnostic Laboratories Microbiology/Molecular Department.  This test is used for clinical purposes and should not be regarded as investigational or for research use.  This laboratory is certified under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Laboratory

Wisconsin Diagnostic Laboratories
 

Synonyms

  • 2019-nCOV
  • Wuhan
  • SARS-COV

Alt Container

M4RT, M5, VTM (Viral transport medium), UTM (Universal testing medium), Phosphate buffered saline, Eswab (Liquid Amies) transport media
 

Last Updated

03/06/2020, 03/16/2020, 03/25/2020, 04/08/2020, 04/10/2020, 4/16/2020, 4/17/2020, 8/31/2020

CPT Codes

87635/U0003, U0004 (previously U0002)
 

LOINC

  • 41458-1

PDM

3556190
Specimen Collection

Ordering Recommendations

A combination of nasopharyngeal and throat specimens is optimal for testing. Submit both swabs in the same tube of Viral Transport Medium. Sputum or BAL specimens are also acceptable.
If only 1 swab is available, nasopharyngeal only testing is acceptable. Throat specimens are not acceptable.

Test Includes

2019 Novel Coronavirus (SARS-CoV-2 (COVID-19)) RNA testing by PCR

Collect

M6 or M4 Viral Transport Medium,M4RT, M5, VTM (Viral transport medium), UTM (Universal testing medium),  Sterile Screw Cap Container

During the Pandemic additional sample collection containers: Phosphate buffered saline, Eswab (Liquid Amies) transport media


Nasopharyngeal Collection Video

Specimen Preparation

NASOPHARYNGEAL: Insert a flexible mini-tip swab through the nostril into the nasopharynx. Rotate gently and withdraw. Place swab into M6 or M4 Viral Transport Medium.
NASOPHARYNGEAL/OROPHARYNGEAL (THROAT): Insert a flexible mini-tip swab through the nostril into the nasopharynx. Rotate gently and withdraw. Place swab into Viral Transport Medium. With the second swab, swab both tonsillar areas, posterior pharynx and any areas of inflammation, ulceration, or exudation. Place swab into Viral Transport Media with the NP swab.
SPUTUM: Have patient cough deeply and collect entire specimen of expectorated sputum in a sterile screw-cap container without additives.  (0.5 mL minimum). Samples collected at clients should be mixed 1:1 with Viral transport media.
BAL: Collect specimen using aseptic technique and accepted methods. Submit 5.0 mL in a sterile screw-cap container without additives.  (0.5 mL minimum).
Samples collected at clients should be mixed 1:1 with Viral transport media.

Storage/Transport Temperature

Refrigerate

Unacceptable Conditions

Inappropriate specimen type (throat or nasal), inadequate volume, inappropriate transport device, leaking specimen.

Stability (from collection to initiation)

Ambient or Refrigerated Specimens in Viral Transport Medium (VTM): 72 hours
Specimens not in VTM:  24 hours
Frozen: 1 month

Remarks

SARS-CoV-2 (2019-nCoV) is the virus which causes the disease named "coronavirus disease 2019" (abbreviated "COVID-19").  This test utilizes CDC-developed target sequences for the detection of SARS-CoV-2 RNA in combined nasopharyngeal/throat swab specimens collected in Viral Transport Medium.
Result Information

Performed

Monday-Sunday

Reported

Froedtert Inpatient and Emergency room: 6 hours
Outpatient: 24 hours

Methodology

Real Time Polymerase Chain Reaction (PCR) Amplification

Reference Interval

Not Detected

Interpretive Data

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.

This test is a CDC-developed real-time PCR assay intended for the qualitative detection of SARS-CoV-2 (COVID-19) nucleic acid.  This assay has Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for specimens collected from individuals who meet CDC criteria for SARS-CoV-2 testing.  Test performance characteristics were determined by the Wisconsin Diagnostic Laboratories Microbiology/Molecular Department.  This test is used for clinical purposes and should not be regarded as investigational or for research use.  This laboratory is certified under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Laboratory

Wisconsin Diagnostic Laboratories
 
Additional Information

Synonyms

  • 2019-nCOV
  • Wuhan
  • SARS-COV

Alt Container

M4RT, M5, VTM (Viral transport medium), UTM (Universal testing medium), Phosphate buffered saline, Eswab (Liquid Amies) transport media
 

Last Updated

03/06/2020, 03/16/2020, 03/25/2020, 04/08/2020, 04/10/2020, 4/16/2020, 4/17/2020, 8/31/2020
Coding

CPT Codes

87635/U0003, U0004 (previously U0002)
 

LOINC

  • 41458-1
Interface Mapping

PDM

3556190