Assay Sheet
For in vitro diagnostic use
Test ID
RV00 Respiratory Viral Panel (RVP)
CPT Code
87798 (x12)
Clinical Utility
The Respiratory Viral Panel is a comprehensive assay for the detection of a broad range of viruses and subtypes representing the majority of circulating respiratory disease-causing pathogens of particular importance to children, elderly, and immunocompromised patients. Detection of these pathogens will lead to more efficient management of patients with respiratory infections, play a key role in surveillance, and aid in limiting the spread of respiratory viruses through infection control practices.
Procedure
Viral nucleic acid is extracted from the specimen, which undergoes reverse transcription to generate complementary DNA (cDNA). The target cDNA is amplified using polymerase chain reaction (PCR), then analyzed with Luminex® xTag™ technology to detect the presence or absence of each virus in the panel. The Respiratory Viral Panel (RVP) has been cleared by the FDA for in vitro diagnostic use.
Specimen type & specimen handling
**Bronchial Lavage/Bronchial Wash: 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Sputum: 2 mls collected in a sterile container, then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
**Throat Gargle: 2 mls collected in a sterile container then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
**Upper respiratory aspirate (NP aspirate, nasal aspirate/wash, tracheal aspirate, etc.): 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Upper respiratory swab (*NP swab, **throat swab): Sterile swab placed in 2 ml sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
CSF: 2 mls collected in a sterile, screw top tube. Freeze and ship on dry ice Monday thru Friday. Specimen must be received within 96 hrs of collection.
All suction-type collection devices are inappropriate for specimen transport. Transfer specimen into sterile, leakproof tube for transport.
Call ViraCor for authorization prior to sending any specimen type other than those listed above.
If another specimen type has received authorization for testing the following comment will appear in the final report: "The clinical utility of this result has not yet been demonstrated in the peer reviewed literature and is therefore unknown."
Causes for rejection
Specimens other than those listed above that were sent without prior authorization.
Wood shafted swab, calcium alginate swab.
Call ViraCor at 800-305-5198 if specimen is greater than 96 hrs old.
Specificity
Detects 12 Respiratory viral targets: respiratory syncytial virus (RSV) A, respiratory syncytial virus (RSV) B, influenza A, influenza A subtype H1, influenza A subtype H3, influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, human metapneumovirus (hMPV), rhinovirus, and adenovirus.
Assay Range
Qualitative results (Positive/Not Detected) for: RSV A, RSV B, influenza A, influenza A subtype H1, influenza A subtype H3, influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, hMPV, rhinovirus, and adenovirus.
Turnaround Time
Same day (within 12 to 18 hours of receiving specimen), Monday through Saturday
Shipping
Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. Multiple tests can be run on one specimen.
Ship specimens FedEx Priority Overnight® to:
ViraCor Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086
* NP swab has been cleared by the FDA for use in the RVP assay.
**In-house verification performed to establish as suitable specimen types.
CPT codes provided are based on ViraCor’s interpretation of the American Medical Association’s Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. ViraCor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material. Information derived from Respiratory Viral Panel Package Insert (Luminex Corporation).
Respiratory Viral Panel is a product of Luminex Corporation. xTAG is a trademark of Luminex Corporation. Luminex is a registered trademark of Luminex Corporation.
0109 V3
Pathogen Overview
ABOUT RESPIRATORY SYNCYTIAL VIRUS
Respiratory syncytial virus (RSV) is a negative-sense, single-stranded, enveloped RNA virus of the Paramyxoviridae family. RSV is a single serotype with 2 antigenic subgroups, A and B, which differ in surface glycoproteins. Both subgroups cocirculate, though type A is more common. Human RSV was first isolated in 1965 from a laboratory chimpanzee displaying symptoms similar to the common cold; soon afterwards it was isolated from infants with respiratory illness. RSV has since been recognized as the leading cause of serious respiratory tract disease in children worldwide and is one of the most infectious human viruses known. Nearly 100% of children in the United States have been infected with RSV by the age of 2 to 3 years; however, incomplete immunity to the virus enables reinfection at any point later in life. RSV causes seasonal epidemics, which usually peak in January or February in the United States. Those at highest risk for severe disease include children with bronchopulmonary dysplasia, extremely low birth weight infants, patients with congenital heart disease, the elderly, and immunocompromised patients. RSV is the most commonly identified viral cause of respiratory tract infection in hematopoietic stem cell transplant (HSCT) and solid organ transplant patients.
RESPIRATORY SYNCYTIAL VIRUS CLINICAL MANIFESTATIONS
RSV infection usually begins as an upper respiratory tract infection with cough, rhinorrhea, fever, decreased appetite, wheeze, lethargy, and respiratory distress, with cough and rhinorrhea as the main symptoms. Reinfection in older children and adults tends to be more mild and limited to the upper respiratory tract; recovery typically occurs in 7 to 12 days. Primary infection at 6 weeks to 2 years of age usually involves the lower respiratory tract; symptoms include apnea, otitis media, fever, bronchiolitis, and pneumonia. Neonates may only present with apnea. Pneumonia is the most common symptom in the elderly. Croup, central nervous system involvement, heart conditions, and skin exanthems of the trunk and face, are uncommon manifestations of RSV. Chest radiograph findings include hyperaeration, prominent lung markings due to bronchial wall thickening, and focal areas of atelectasis. Interestingly, patients who exhibit bronchiolitis during primary RSV infection often continue wheezing years later and are diagnosed with asthma; however, this association is still unclear.
RSV infection in immunocompromised patients is similar to that in immunocompetent hosts; however, immunocompromised patients are at a greater risk for complications. A high risk for pneumonia and increased mortality rates are associated with RSV infection pre-transplantation or less than one month post-transplantation. Approximately half of HSCT patients with RSV develop lower respiratory tract infections, which significantly increases mortality rates. Allogeneic HSCT recipients are more susceptible to RSV infection compared with autologous HSCT recipients. Pediatric liver and adult lung transplant patients are also at a higher risk.
RESPIRATORY SYNCYTIAL VIRUS LABORATORY DIAGNOSIS
Viral culture is a common method of RSV detection, though it is time consuming, taking 3 to 14 days. Fluorescent antibody techniques are more timely, though poor negative predictive values are a significant limitation of this method. Adults, especially immunocompromised patients, shed low titres of the virus; therefore, fluorescent antibody tests are commonly combined with viral culture to confirm diagnosis. The need for a rapid and highly sensitive diagnostic method is significant. Polymerase chain reaction (PCR) is gaining clinical acceptance since it has been shown to be a rapid, sensitive and specific method for detecting RSV.
RESPIRATORY SYNCYTIAL VIRUS TREATMENT
RSV is mostly regarded as a community-acquired infection; however, nosocomial infection occurs frequently. Spread of infection can be prevented with careful hand hygiene practices, as inoculation occurs through direct contact with fomites or other infected objects. Isolation measures can help prevent spread of infection by close contact and large respiratory droplet transmission; however, prolonged viral shedding in immunocompromised patients and an incubation period of 4 to 5 days can make this challenging.
Antiviral therapy for RSV infections is limited and controversial. Aerosolised ribavirin in combination with RSV immune globulin or palivizumab, a monoclonal antibody formulation, is recommended by the American Society of Transplantation (AST). Postponement of transplantation should be considered for patients suspected of an RSV infection.
Selected References
Knipe D, Howley P. Fields Virology. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2006.
Lee I, Barton TD. Viral respiratory tract infections in transplant patients: epidemiology, recognition and management. Drugs. 2007;67(10):1411-1427.
Mahoney J, Chong S, Merante F, et al. Development of a respiratory virus panel (RVP) test for the detection of twenty human respiratory viruses using multiplex PCR and a fluid microbead-based assay. J Clin Microbiol. 2007;45(9):2965-2970.
Ogra PL. Respiratory syncytial virus: the virus, the disease and the immune response. Paediatr Respir Rev. 2004;5 Suppl A:S119-S126.
Small TN, Casson A, Malak SF, et al. Respiratory syncytial virus infection following hematopoietic stem cell transplantation. Bone Marrow Transplant. 2002;29(4):321-327.
PAO-17-0907
Abstracts & Publications
Knipe D, Howley P. Fields Virology. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2006.
Lee I, Barton TD. Viral respiratory tract infections in transplant patients: epidemiology, recognition and management. Drugs. 2007;67(10):1411-1427.
Mahoney J, Chong S, Merante F, et al. Development of a respiratory virus panel (RVP) test for the detection of twenty human respiratory viruses using multiplex PCR and a fluid microbead-based assay. J Clin Microbiol. 2007;45(9):2965-2970.
Ogra PL. Respiratory syncytial virus: the virus, the disease and the immune response. Paediatr Respir Rev. 2004;5 Suppl A:S119-S126.
Small TN, Casson A, Malak SF, et al. Respiratory syncytial virus infection following hematopoietic stem cell transplantation. Bone Marrow Transplant. 2002;29(4):321-327.
