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HelpTest Code SCOF3 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) and Influenza Virus Type A and Type B RNA, 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 Types: Oropharyngeal (throat) swab, nasal mid-turbinate, or nares/nasal swab
Supplies:
-Culturette (BBL Culture Swab) (T092)
-Mid Turbinate (MT) Swab (FLOQSwab/COPAN) (T864)
-Swab, Sterile Polyester (T507)
Container/Tube: Sterile container with transport media
Specimen Volume: Entire specimen with a minimum of 1.5 mL (maximum 3 mL) of transport media.
Preferred: BBL Culture Swab, COPAN Mid-turbinate Swab
Acceptable: Dacron-tipped swab with plastic handle
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 Types: Bronchial washings, endotracheal aspirate, sputum
Container/Tube: Sterile container
Specimen Volume: 0.6 mL
Additional Information: Do not aliquot into viral transport media.
Secondary ID
622027Useful For
Simultaneous detection and differentiation of SARS-CoV-2 (cause of COVID-19), influenza A virus, and influenza B virus in upper or lower respiratory tract specimens from individuals with flu-like illnesses
Testing Algorithm
For information see Coronavirus Disease 2019 (COVID-19), Influenza, and Respiratory Syncytial Virus Testing Algorithm.
Method Name
Multiplex Reverse Transcriptase, Real-Time Polymerase Chain Reaction (RT-qPCR)
Specimen Type
VariesSpecimen Minimum Volume
Upper respiratory tract swab: See Specimen Required; lower respiratory specimens: 0.3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Frozen (preferred) | 14 days | |
| Refrigerated | 72 hours |
Reject Due To
| Bloody specimens Calcium alginate-tipped swab Wooden swab Dry swab Glass transport tubes Transport swab containing gel or charcoal additive Transport media tubes containing the entire swab Sample tubes containing guanidine isothiocyanate, guanidine thiocyanate, or guanidine hydrochloride |
Reject |
Reference Values
Undetected
Interpretation
A "Detected" (positive) test result indicates that the patient is presumptively infected with the indicated virus. The test does not indicate the stage of infection. Rarely, more than one virus may be detected from the same patient specimen. Laboratory test results should always be considered in the context of clinical observations and epidemiologic data in making a final diagnosis.
An “Undetected" (negative) test result suggests that the patient is not infected with SARS-CoV-2, influenza A virus, and influenza B virus.
An "Inconclusive" result indicates that the presence or absence of SARS-CoV-2, influenza A virus, and influenza B virus in the specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to real-time, reverse transcription polymerase chain reaction inhibition. Submission of a new specimen for testing is recommended.
Method Description
The SARS-CoV-2/Flu A/B/RSV assay (Panther Fusion System, Hologic, Inc.) is a fully automated, multiplexed, real-time polymerase chain reaction (PCR) in vitro diagnostic assay cleared by the US Food and Drug Administration (FDA) for qualitative detection and differentiation of SARS-CoV-2, influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV) in nasopharyngeal specimens (ie, upper respiratory tract: URT) obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. In addition to testing URT specimens, this assay is being used to test lower respiratory tract (LRT) specimens, which are not cleared by FDA for testing with this assay. In the testing laboratory, 0.5 mL of the viral transport medium with URT swab is transferred to the Hologic Specimen Lysis Tube (SLT) to be loaded onto the Panther Fusion system. For LRT specimens, 0.25 mL of the specimen from the transport container and 0.25 mL of sterile Gibco 1x PBS, pH 7.4 are transferred into the SLT for loading onto the instrument system.
This assay involves the following steps: sample lysis, nucleic acid capture and elution transfer, and multiplex RT-PCR in which analytes are simultaneously amplified, detected, and differentiated. Nucleic acid capture and elution takes place in a single tube on the Panther Fusion system. The Internal Control-S (IC-S) is added to each test specimen and positive and negative assay controls via the working Panther Fusion Capture Reagent-S. The IC-S reagent monitors specimen processing, amplification, and detection. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents, and multiplex RT-PCR is then performed on the eluted nucleic acid.
Viral target-specific forward and reverse primers and probes simultaneously amplify, detect, and differentiate among the viral target sequences with various fluorescence channels. The assay software compares the fluorescence signals generate to predetermined cutoff values to produce a qualitative result for the presence or absence of each virus.(Instruction manual: SARS-CoV-2/Flu A/B/RSV assay [Panther Fusion System], AW-27555-001. Hologic, Inc.; Rev. 001, 05/2023)
Day(s) Performed
Monday through Sunday
Report Available
Same day/1 to 2 daysSpecimen Retention Time
4 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
87636
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| SCOF3 | SARS-CoV-2 and Influenza A/B PCR, V | 95422-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| SCOS3 | SARS-CoV-2 & Flu A/B, Source | 31208-2 |
| 622028 | Influenza A virus PCR | 92142-9 |
| 622029 | Influenza B virus PCR | 92141-1 |
| 622030 | SARS CoV-2 RNA, PCR | 94500-6 |