COVID & Influenza A/B & RSV PCR, Routine
Test Mnemonic
CVFLRS
CPT Codes
- 87637 - QTY (1)
LOINC ®
95941-1
Aliases
- COV2
- COVID
- Flu
- Influenza
- Respiratory syncytial virus
- RSV
- SARS
- CVFLRS
- Respiratory
- SQCVFLRS
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
In Vitro Diagnostic
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 3 mL | Nasopharyngeal swab | Universal Transport Media (UTM) | Refrigerated | 1. Tilt patient's head back 70 degrees. 2. Gently and slowly insert a mini-tipped flocked swab with a flexible shaft (ie. Oracle 1172111) 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. 3. Gently rub and roll the swab. 4. Leave swab in place for several seconds to absorb secretions. 5. 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 swab 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. 6. Place swab, tip first, into the transport tube provided. Break the swab shaft at the score line, discard the top portion of the stem, and close the cap. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 3 mL | Swab(s) | Saline | Refrigerated | Sterile saline may be used to collect swabs if UTM cannot be sourced. | |
| 1 mL | Swab(s) | E Swab | Refrigerated | E-swabs in liquid amies may be used to collect swabs if UTM cannot be sourced. | |
| 3 mL | Swab(s) | Viral Transport Media | Refrigerated | Viral transport media (including VTM, M4RT, M5, or M6) may be used to collect swabs if UTM cannot be sourced. | |
| 3 mL | Nasal | Universal Transport Media (UTM) | Refrigerated | 1. Insert the entire collection tip of the regular-tip flocked swab with a rigid shaft (ie. Orcale 1063581) 1/2-3/4 of an inch or 1-1.5 cm inside the nostril. 2. Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 4 times. 3. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present on the swab. 4. Repeat in the other nostril using the same swab. 5. Place swab, tip first, into the transport tube provided. Break the swab shaft at the score line, discard the top portion of the stem, and close the cap. | |
| 1 mL | Bronch (BAL) | Sterile container | Refrigerated | Collect 2-3 mL into a sterile, leak-proof, screw-cap collection cup or sterile dry container (ie. Oracle 1619591). If aliquotting is necessary, sterile aliquot tubes must be used. Do not dilute with transport media. | |
| 1 mL | Sputum | Sterile container | Refrigerated | Before collecting a sputum, have the patient rinse their mouth with water and discard the rinse fluid. Ask the patient to breathe deeply for three or four breaths, then hold their breath and expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap collection cup or sterile dry container (ie. Oracle 1619591). Induced sputum is also acceptable. If aliquotting is necessary, sterile aliquot tubes must be used. Do not dilute with transport media. | |
| 1 mL | Aspirate, tracheal | Sterile container | Refrigerated | Collect 2-3 mL into a sterile, leak-proof, screw-cap collection cup or sterile dry container (ie. Oracle 1619591). If aliquotting is necessary, sterile aliquot tubes must be used. Do not dilute with transport media. |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 96 hours |
| Frozen | 30 days |
| Ambient | 24 hours |
Days Performed
Sun - Sat
Turnaround Time
1 day
Methodology
| Name | Description |
|---|---|
| Reverse Transcription/Polymerase Chain Reaction (RT/PCR) |
Reference Range
Special Info
For Cleveland Clinic providers, note that this test can only be ordered from an ambulatory setting, unless it is for a lower respiratory specimen. Inpatient/ED providers should order the expedited version of this test (SQEXCFR) on upper respiratory specimens.
Clinical Info
Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 (agent of COVID-19), influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV) can be similar. These viruses are responsible for significant morbidity and mortality, especially in young, immunocompromised, and elderly patients. Accurate and timely diagnosis and differentiation between these viruses can help guide appropriate antiviral therapy, decrease inappropriate use of antibiotics, and assist in infection prevention/control efforts. The FDA-cleared Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed reverse-transcription real-time polymerase chain reaction (RT-PCR) test intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans. It is not intended to detect influenza C virus infections. SARS-CoV-2, Flu A, Flu B, and RSV are generally detectable in nasopharyngeal (NP) and nasal swabs during the acute phase of infection. The assay has been modified and validated to additionally accept lower respiratory specimens (bronchoalveolar lavage, tracheal aspirate, sputum), and swabs in alternative transport media such as liquid Amies (eSwab) and saline. Nasal swabs demonstrate modestly decreased analytical sensitivity compared to NP swabs in some studies, but can be useful in cases where a patient is unable or unwilling to have an NP swab collected. Some individuals can have disease isolated to the lower respiratory tract; consider submitting these specimen types in patients with evidence of lower respiratory disease.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. In co-infections, there may be competitive interference causing loss of analytical sensitivity for one or more targets. Recent administration of intranasal vaccines (ie. FluMist) may lead to false positive results. As with any nucleic acid amplification test, positive results do not rule out coinfection with other organisms, detected organisms may not be the definite cause of disease, and negative results do not rule out infection.
Clinical Reference
1. U.S. Centers for Disease Control (CDC). Testing Guidance for Clinicians When SARS-CoV-2 and Influenza Viruses are Co-circulating. Accessed September 1, 2023. https://www.cdc.gov/flu/professionals/diagnosis/testing-guidance-for-clinicians.htm. 2. U.S. Centers for Disease Control (CDC). Respiratory Syncytial Virus Infection (RSV): For Healthcare Providers. Accessed September 1, 2023. https://www.cdc.gov/rsv/clinical/index.html. 3. U.S. Food and Drug Administration (FDA). 510(k) Substantial Equivalence Determination Decision Summary K222736. Accessed September 1, 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222736.pdf.