COVID & Influenza A/B & RSV NAAT, Routine
Test Mnemonic
CVFLRS
CPT Codes
- 87637 - QTY (1)
Aliases
- corona
- coronavirus
- COV
- COV2
- COVID
- Flu
- Influenza
- resp virus
- Respiratory syncytial virus
- Respiratory virus
- RSV
- SARS
- SARS-COV-2
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| Swab | Nasopharyngeal swab | Universal Transport Media (UTM) | Refrigerated | 1 .Tilt patient’s head back 70 degrees. 2. Gently and slowly insert a swab with a flexible shaft 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. | |
| Swab | Nasal | Universal Transport Media (UTM) | Refrigerated | 1. Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 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 | Aspirate, tracheal | Sterile container | Refrigerated | Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. | |
| 1 mL | Bronch (BAL) | Sterile container | Refrigerated | Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. | |
| 1 mL | Sputum | Sterile container | Refrigerated | Have the patient rinse the mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap collection cup or sterile dry container. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| Swab | Saline | Refrigerated | Sterile saline may be used if UTM cannot be sourced. | ||
| Swab | E Swab | Refrigerated | E-swab may be used if UTM cannot be sourced. | ||
| Swab | Viral Transport Media | Refrigerated | Viral transport media (including VTM, M4RT, M5, or M6) may be used if UTM cannot be sourced. |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 96 hours |
| Frozen | 30 days |
Days Performed
Sun - Sat
Turnaround Time
1 day
Methodology
| Name | Description |
|---|---|
| Nucleic Acid Amplification (NAA) |
Reference Range
| COVID 19 Result NP | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Negative for COVID19 (SARS CoV2) by RT-PCR or equivalent method. |
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-approved 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) swabs during the acute phase of infection. The assay has been modified and validated to additionally accept nasal swabs, 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. 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 Limitation
1. The performance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay has not been specifically evaluated in a population known to be vaccinated against illnesses caused by any of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay analytes (e.g. SARS-CoV-2 (COVID-19) or, influenza, etc.). 2. The performance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay has not been established for monitoring treatment of infection with any of the panel organisms. 3. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be able to distinguish between existing viral strains and new variants as they emerge. 4. Positive and negative predictive values are highly dependent on prevalence. The likelihood of a negative result being false is higher during peak activity when prevalence of disease is high. The likelihood of a positive result being false is higher during periods when prevalence is moderate to low. 5. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 6. This test does not differentiate influenza A subtypes (i.e., H1N1, H3N2) or RSV subgroups (i.e., A or B); additional testing is required to differentiate any specific influenza A subtypes or strains or specific RSV subgroups, in consultation with local public health departments. 7. A positive result indicates the detection of nucleic acid from the relevant virus. Nucleic acid may persist in vivo even after the virus is no longer viable. Detection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents or clinical symptoms. 8. Interference was observed for SARS-CoV-2 when evaluated with high concentrations of RSV B, for Flu A when evaluated with high concentrations of SARS-CoV-2 or RSV B, and for Flu B when evaluated with high concentrations of RSV B. 9. Recent administration of nasal vaccines (e.g., FluMist®) prior to collection were not evaluated; Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may detect the agents in those vaccines but may not represent infection by those viruses. 10. Zinc was not evaluated in the Interfering Substance Study. 11. Performance characteristics for influenza A were established when influenza A/H1 and A/H3 were predominant. When other influenza A viruses are emerging, performance characteristics may differ. 12. The clinical performance has not been established for all circulating variants of SARS-CoV-2 but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
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.