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 HUMAN PARAINFLUENZA VIRUS
The human parainfluenza viruses (HPIVs) consist of 4 serotypes, 1-4. They are negative-sense, single-stranded RNA viruses of the Paramyxoviridae family. The HPIVs were first discovered between 1956 and 1960. HPIV1, HPIV2, and HPIV3 were isolated from infants and children with lower respiratory tract disease; HPIV4 was isolated from children and young adults with mild upper respiratory disease. HPIV infection is one of the leading causes of lower respiratory tract disease among children, second only to respiratory syncytial virus (RSV). The 4 serotypes of HPIV differ in seasonality, prevalence, and clinical disease. HPIV1 and 2 are the leading causes of childhood laryngotracheobronchitis (LTB) and are most prevalent in the fall and winter months. HPIV3 is found year-round, but it is most prevalent in the spring and early summer months. HPIV3 is more often associated with adult disease and bronchiolitis or pneumonia, especially in elderly and immunocompromised patients. HPIV4 is not frequently detected and has not been well characterized.
HUMAN PARAINFLUENZA VIRUS CLINICAL MANIFESTATIONS
HPIV is a common community-acquired infection in children and presents as rhinitis, pharyngitis, cough, and hoarseness with a fever that lasts approximately 2 to 3 days. Otitis media occurs frequently, and the virus can be detected in the middle ear fluid of these patients. The initial symptoms progress when acute LTB develops, which varies in intensity, but typically lasts 48 to 72 hours. After a few days, the cough worsens, becoming barky and seal-like. The infection progresses to the lower respiratory tract approximately 15% of the time; fever and productive cough are accompanied by wheeze, retractions, tachypnea, and, in severe cases, cyanosis. Chest radiographs show interstitial or perihilar infiltrates and air trapping. Children may develop bronchopneumonia-croup syndrome or severe pulmonary disease following HPIV infection that resembles adult respiratory distress syndrome.
Infections in immunocompetent adults, who have developed incomplete immunity, tend to be mild and restricted to the upper respiratory tract. However, HPIV infections can cause prolonged and significant disease in immunocompromised patients. HPIV3 is the most common serotype isolated in the transplant population and initially presents as an upper respiratory tract infection with cough as the main symptom; rhinorrhea, wheeze, coryza, and fever are less common. The infection may progress to the lower respiratory tract and lead to pneumonia and respiratory failure; this occurs in approximately one-third of hematopoietic stem cell transplant (HSCT) patients. Lung transplant patients are at higher risk for lower respiratory tract infection. Corticosteroid treatment for graft-versus-host disease (GVHD) is a significant risk factor for progression to the lower respiratory tract. Pulmonary copathogens, particularly A. fumigates, are commonly isolated from patients with HPIV pneumonia, which significantly contributes to the mortality rate. Bronchiolitis obliterans and allograft rejection in lung transplant recipients are commonly associated with HPIV infections. Rates of infection between autologous and allogeneic HSCT recipients seem to be similar, though there are limited studies on HPIV infection in the transplant community.
HUMAN PARAINFLUENZA VIRUS LABORATORY DIAGNOSIS
Viral culture is a common method of HPIV 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. In addition, the tendency of adults to shed low titres of the virus adds to the method’s limitations. 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 HPIV.
HUMAN PARAINFLUENZA VIRUS TREATMENT
HPIV is mainly a community-acquired infection, though nosocomial spread does occur. 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 respiratory droplet transmission; however, asymptomatic viral shedding and an incubation period of
1 to 7 days can make this challenging.
Treatment options for HPIV infection are limited. Clinical studies of ribavirin, with or without IVIG, have yielded mixed results. Bacterial and fungal coinfections should be carefully monitored.
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.
Nichols WG, Corey L, Gooley T, et al. Parainfluenza virus infections after hematopoietic stem cell transplantation: risk factors, response to antiviral therapy, and effect on transplant outcome. Blood. 2001;(98):573-578.
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.
Nichols WG, Corey L, Gooley T, et al. Parainfluenza virus infections after hematopoietic stem cell transplantation: risk factors, response to antiviral therapy, and effect on transplant outcome. Blood. 2001;(98):573-578.
