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 RHINOVIRUS
Rhinoviruses are non enveloped, single-stranded RNA viruses from the Picornaviridae family, along with enteroviruses. In contrast to enteroviruses, rhinoviruses do not replicate in the intestinal tract. Approximately 100 serotypes of human rhinovirus have been identified. Rhinoviruses are the most frequent cause of the common cold. Infections occur throughout the year, but are more prevalent in early fall and late spring.
RHINOVIRUS CLINICAL MANIFESTATIONS
Rhinovirus infections cause self-limited upper respiratory illness, characterized by sneezing, nasal obstruction, nasal discharge, and sore throat. Headache, cough, and malaise are common symptoms, though fever is rare in rhinovirus infections. Approximately one-third of rhinovirus infections are asymptomatic. The median duration of uncomplicated illness is 7 days, with symptoms peaking 1 to 3 days after onset before progressively improving. Rhinovirus infection is a major cause of asthma exacerbations in school-aged children. The virus has also been associated with otitis media and exacerbations of cystic fibrosis in children and chronic bronchitis and COPD in adults. Rhinovirus infections in the elderly have been associated with severe and fatal illness, as evidenced by nursing home outbreaks.
Though previously a topic of debate, it has been established that rhinovirus has the ability to replicate in the lower respiratory tract. Recent studies have reported rhinovirus as a cause of lower respiratory tract infections in patients with predisposing conditions, such as a compromised immune status. In a study of hematopoietic stem cell transplant (HSCT) patients, 5 of 6 rhinovirus-positive patients died from severe lower respiratory tract disease. However, since all of the patients infected with rhinovirus had a coinfection, it is unclear which agent, rhinovirus or the copathogen, was the primary cause of mortality. Additional studies are needed to determine if rhinovirus causes lytic infection or acts primarily through an indirect immunosuppressive effect to predispose patients to superinfections. Another study describes 3 lung transplant recipients chronically infected with rhinovirus; 2 of the 3 patients had chronic upper respiratory tract symptoms and all 3 patients had recurring lower respiratory tract symptoms. All 3 patients had graft dysfunction and 2 patients died. Rhinovirus was the only pathogen identified. The patients failed to produce neutralizing antibodies against the virus due to significant immunosuppression; therefore, chronic rhinoviral infection could be considered an opportunistic event. Chronic infection lasting months or years with other members of the Picornaviridae family, such as enterovirus, is recognized in immunocompromised hosts. This scenario may be applicable to rhinovirus, which is structurally and functionally similar to other picornaviruses. While additional studies are needed to determine the impact of rhinovirus in the immunocompromised patient population, the virus is emerging as an important pathogen that needs to be considered, especially in lung transplant recipients.
RHINOVIRUS LABORATORY DIAGNOSIS
Virus isolation in cell culture, followed by an acid lability test, has been the conventional method to diagnose rhinovirus infections. However, fastidious growth requirements of rhinovirus make the technique time-consuming and laborious. Poor negative predictive values add to the method’s limitations. Serological tests are not useful because of the large number of rhinovirus serotypes. The need for a rapid and highly sensitive diagnostic method is significant. Polymerase chain reaction (PCR) is gaining acceptance it has been shown to be a rapid, sensitive and specific method for detecting rhinovirus.
RHINOVIRUS TREATMENT
Rhinovirus is mainly a community acquired infection, though nosocomial spread does occur. Strict infection control practices, including isolation measures and careful hand hygiene practices, can help prevent the spread of infection.
Treatment options for rhinovirus infection are limited. Pleconaril, which inhibits viral uncoating and/or attachment, has been used in transplant patients with rhinoviral pneumonia, though its efficacy is still unknown.
Selected References
Ison M, Hayden F, Kaiser L, et al. Rhinovirus infections in hematopoietic stem cell transplant recipients with pneumonia. Clin Infect Dis. 2003;(36):1139-1143.
Kaiser L, Aubert J, Pache J, et al. Chronic rhinoviral infection in lung transplant recipients. Am J Respir Crit Care Med. 2006;(174):1392-1399.
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.
PAO-21-09
Abstracts & Publications
Ison M, Hayden F, Kaiser L, et al. Rhinovirus infections in hematopoietic stem cell transplant recipients with pneumonia. Clin Infect Dis.2003;(36):1139-1143.
Kaiser L, Aubert J, Pache J, et al. Chronic rhinoviral infection in lung transplant recipients. Am J Respir Crit Care Med. 2006;(174):1392-1399.
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.
