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Test Code CV19 Coronavirus COVID-19

Important Note

Click here for collection instructions.

 

MaineHealth Respiratory Ordering Guidance

Additional Codes

Software Test Code
Label Text CV19
EPIC LAB20442

Performing Laboratory

NorDx Laboratories

Useful For

Detection of SARS-CoV-2 to assist in the diagnosis of COVID-2019 infections.

Test performance is not impacted by mutations in the SARS-CoV-2 Delta or Omicron Variants.

Clinical Significance

There is an outbreak of respiratory disease caused by a novel (new) coronavirus that was first detected in China and which has now been detected in locations all over the world, including in the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”).

Method Name

Real Time-Polymerase Chain Reaction (rt-PCR)

 

This assay is a lab developed test established by the NorDx Molecular Pathology Laboratory. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

Reference Values

NOT DETECTED

 

Days and Times Test Performed

Daily

Report Available

Generally within 24 hours

Specimen Type

Submit one of the following:

  • Nasopharyngeal swab 
  • Mid-turbinate swab
  • Nasal swab

 

Provider must consult with Infectious Disease dept. before ordering:

~ Tracheal Aspirate (Inpatients only)

~ Bronchoalveolar Lavage – (Inpatients only)

~ Endotracheal sputum (Lukens) - (Inpatients only)

Preferred Container

Any of the following media approved for viral transport:

  • UTM,VTM,STM, M4, M5 media

 

 

 

 

Preferred Volume

Preferred Volume: Nasopharyngeal and mid-turbinate swab: 1.0 mL in  acceptable viral transport media.

Acceptable volume: Nasopharyngeal and mid-turbinate swab: up to 3.0 mL in  acceptable viral transport media.

 

Bronchoalveolar Lavage: 2 mL

Tracheal Aspirate: 3 mL

Minimum Volume

Nasopharyngeal and mid-turbinate swab: 1.0 mL in  acceptable viral transport media.

 

Bronchoalveolar Lavage: 1 mL

Tracheal Aspirate: 1 mL

Specimen Collection and Handling

Use only synthetic fiber swabs with plastic or wire shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and may inhibit molecular tests.

NASOPHARYNGEAL 

1Insert minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

2. Place specimen in viral media.

3. Maintain sterility, forward promptly and send refrigerated.

MID-TURBINATE SWAB:

1. Use a flocked tapered swab. Tilt patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met at turbinates). Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. Unless there is a contraindication, both sides should be sampled with a single swab.

2. Place specimen in viral media.

3. Maintain sterility, forward promptly and send refrigerated

Specimen Stability Information

Ambient:  48 Hours

Refrigerated: 7 Days

Frozen: 30 Days

Add On Capable

Yes.  Specimens stored frozen in testing area for 48 hours.

Advance Beneficiary Notice Requirements

No ABN Required

CPT Code Information

CPT Code

CPT Description

CPT Disclaimer

87635  Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique  

Keywords

COV19

COVID-19

SARS-CoV-2

Rejection Information

Expectorated sputum has not been validated for this test

Oropharyngeal swab in transport media has not been validated for this test

Acceptable Alternative Container(s)

Screw-Capped Sterile Plastic Container/Vial for BAL,

Tracheal Aspirate and Endotracheal sputum specimens