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Test Code HPCOV Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2), Molecular Detection, Varies


Ordering Guidance


Due to the nonspecific clinical presentation of COVID-19 during the early stages of the illness, testing for other respiratory infections (eg, influenza) may be warranted. If this test is ordered with HPFLU / Influenza Virus Type A and Type B and Respiratory Syncytial Virus (RSV) RNA, Molecular Detection, PCR, Varies, then both tests will be canceled and automatically reordered by the laboratory as SCOF4 / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2), Influenza Virus Type A and Type B RNA, and Respiratory Syncytial Virus (RSV) Molecular Detection, PCR, Varies.



Specimen Required


Preferred:

Specimen Type: Nasopharyngeal swab

Container/Tube: Sterile container with viral transport media

Specimen Volume: Entire specimen with a minimum of 1.5 mL (maximum 3 mL) of transport media.

Collection Instructions:

1. Collect specimen by swabbing back and forth over mucosa surface to maximize recovery of cells.

2. Swab must be placed into viral transport media (eg, M4-RT, M4 or M5), saline, or phosphate buffered saline (PBS). Media should not contain guanidine thiocyanate (GTC).

 

Specimen Type: Bronchoalveolar lavage fluid

Container/Tube: Sterile container

Specimen Volume: 0.6 mL

Additional Information: Do not aliquot into viral transport media.

 

Acceptable:

Specimen Type: Oropharyngeal (throat) swab, nasal mid-turbinate, or nares/nasal swab

Supplies:

-Culturette (BBL Culture Swab) (T092)

-Swab, Sterile Polyester (T507)

Collection Container/Tube:

Preferred: BBL Culture Swab or COPAN Mid-turbinate Swab

Acceptable: Dacron-tipped swab with plastic handle

Submission Container/Tube: Swab in sterile container with transport media

Specimen Volume: Entire specimen with a minimum of 1.5 mL (maximum 3 mL) of transport media.

Collection Instructions: Swab must be placed into viral transport media (eg, M4-RT, M4, or M5), saline, or PBS. Media should not contain guanidine thiocyanate (GTC).

 

Specimen Type: Bronchial washings, endotracheal aspirate, sputum

Container/Tube: Sterile container

Specimen Volume: 0.6 mL

Additional Information: Do not aliquot into viral transport media.


Useful For

Diagnosis of COVID-19 illness due to SARS-CoV-2

Reporting Name

SARS CoV-2 RNA, PCR, Varies

Specimen Type

Varies

Specimen Minimum Volume

Upper respiratory tract swab: See Specimen Required; lower respiratory specimens: 0.3 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Frozen (preferred) 14 days
  Refrigerated  72 hours

Reject Due To

Bloody specimen Reject
Calcium alginate-tipped swab Reject
Wooden shaft swab Reject
Dry swab Reject
Glass transport media tubes Reject
Transport swab containing gel or charcoal additive Reject
Sample tubes containing guanidine isothiocyanate, guanidine thiocyanate, or guanidine hydrochloride Reject

Reference Values

Undetected

Method Description

Specimens are transferred first to a specimen lysis tube, which lyses the cells, releases target nucleic acid, and protects them from degradation during storage. The internal control-S (IC-S) is added to each test specimen and control via the working Panther Fusion capture reagent-S. The IC-S in the reagent monitors all aspects of the testing process, including nucleic acid capture, elution, amplification, and detection. Capture oligonucleotides hybridize to nucleic acid in the test specimen. Hybridized nucleic acid is then separated from the specimen in a magnetic field. Wash steps purify the hybridized nucleic acid by removing extraneous components from the reaction tube. The resulting purified nucleic acid is then isolated during the elution step.

 

During the elution transfer step, purified nucleic acid is transferred to a Panther Fusion reaction tube already containing reconstituted master mix overlaid with oil reagent. Amplification of the target sequences occurs via real-time reverse transcription polymerase chain reaction. A reverse transcriptase generates a DNA copy of the target sequences. Target-specific forward and reverse primers and probes amplify and detect 2 regions of the orf1ab gene of SARS-CoV-2 in conjunction with the internal control. The amplified orf1ab target products are detected on the ROX channel, while the internal control is detected on RED677. The assay software compares the viral target and internal control fluorescence signals to predetermined cut-off values to produce a qualitative result for the presence or absence of the virus.(Instruction manual: SARS-CoV-2 Assay [Panther Fusion System]. AW-21159-001. Hologic, Inc; Rev. 006. 05/2022)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Specimen Retention Time

4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87635

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPCOV SARS CoV-2 RNA, PCR, Varies 94559-2

 

Result ID Test Result Name Result LOINC Value
614021 SARS CoV-2 RNA, PCR 94559-2
HPCVS SARS CoV-2 RNA, PCR, Source 31208-2