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Test Code CVDRP Rapid PCR SARS-CoV-2

Important Note

This test is not available at the Brighton, Parkview, South Portland, or Scarborough campuses.  Approved uses include ED patients and inpatients.  It is not for community screening use.  For community screening and non-emergent testing, please see CV19 .

 

MaineHealth Respiratory Ordering Guidance

Additional Codes

Software Test Code
Label text CVDRP
EPIC LAB20536

Performing Laboratory

NorDx Laboratories

Useful For

Detecting SARS-CoV-2 respiratory infection.

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

Method Name

Real-Time Polymerase Chain Reaction (RT-PCR)

Reference Values

Not Detected

Days and Times Test Performed

Monday through Sunday

Report Available

1 Day

Available STAT

Specimen Type

Mid-Turbinate Nasal Swab in Media

Preferred Container

Specimen Collection Kit Manufacturer Part Number

Nasopharyngeal Swab Collection Kits:

Flexible minitip FLOQSwab with Universal Transport Media (UTM) from Copan Diagnostics

or

BD Universal Viral Transport (UVT) 3-mL collection kit with flocked minitip swab

305 C

 

 

220531

Nasal (Mid-Turbinate) Swab Collection Kits:

Regular FLOQSwab with Universal Transport Media (UTM) from Copan Diagnostics

or

BD Universal Viral Transport (UVT) 3-mL collection kit with regular flocked swab

or

Copan Universal Transport Medium (UTM-RT) without beads

 

306C

 

 

220528

 

 

3C047N

ThermoFisher Scientific Remel M4RT

 

 

ThermoFisher Scientific Remel M4

 

 

ThermoFisher Scientific Remel M5

 

 

ThermoFisher Scientific Remel M6

 

 

ThermoFisher Scientific Remel M4RT without beads

 

R12565, R12566, R12567

 

 

 

 

 

 

R12550

 

 

R12555

 

 

R12563, R12568, R12569

 

R12622, R12591

Pre-aliquotted 3 mL 0.9% Physiological Saline

Thomas Scientific MANTACC 0.9% Saline Solution, 3 mL in 10 mL tube, 50 tubes per pack

20A00K984

Preferred Volume

3 mL fill-volume container is the only acceptable initial volume.

Minimum Volume

250 uL sample is needed per run.  Original sample volume must be 3 mL.

Specimen Collection and Handling

Use only sterile synthetic flocked 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 flocked 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. Depending on the swab, break at the score in the shaft without touching the swab tip.

3. Place specimen in viral media.

4. Maintain sterility, forward promptly and send refrigerated.

MID-TURBINATE NASAL SWAB:

1. Use a flocked 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. Depending on the swab, break at the score in the shaft without touching the swab tip.

3.  Place specimen in viral media.

4. Maintain sterility, forward promptly and send refrigerated

Specimen Stability Information

Specimen Type Temperature Time
Transport Media Refrigerated 72 hours
  Ambient 4 hours
  Frozen (-70oC) Indefinitely

 

 

Specimen Type Temperature Time
0.9% Physiological Saline Refrigerated 72 hours
  Ambient 4 hours
  Frozen Not acceptable

Add On Capable

Yes.  Molecular Pathology keeps samples for 48 hours.  Site-specific storage may vary.

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

COVID-19, Novel Coronavirus, Liat, Rapid PCR

Rejection Information

Any fill volume other than 3 mL.

Any transport medium other than those on the approved list.

 

Any collection site other than nasal mid-turbinate or nasopharyngeal.

Wooden shafted or non-flock-tipped swabs.

 

Please note:  The above samples will be rejected for rapid analysis but may be acceptable for routine analysis by Molecular Pathology.

Acceptable Alternative Collection Site

Nasopharyngeal (NP)

Additional Notes and Limitations

This  SARS-CoV-2  Nucleic acid test for use on the cobas® Liat® System is an automated real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection of SARS-CoV-2 virus RNA. 

 

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

 

Negative results must be combined with clinical observations, patient history, and/or epidemiological information. 

 

The D614G and N501Y mutations will not affect the cobas® SARS-CoV-2  Test for use on the cobas® Liat® System because they are in different regions from the target.

LOINC Code Information

95422-2

94500-6

92142-9

92141-1

31208-2

95417-2

95418-0

95419-8

11368-8

95421-4

82810-3

77974-4

95420-6

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