Assay Sheet

Test ID

RV00 Respiratory Viral Panel (RVP)

CPT Code

87798   

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.

Specimens

* Nasopharyngeal swab (NP swab): sterile swab placed in 1-2 ml sterile saline or viral transport media; ship ambient.
**Nasopharyngeal aspirate (NP aspirate), tracheal aspirate, BAL: 2 ml; submitted in a sterile, screw-top tube; ship ambient.

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

Within 24 hours of receiving specimen

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* NP swab has been cleared by the FDA for use in the RVP assay.
**In-house verification performed to establish as suitable specimen types.

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.
AS10-0108

Pathogen Overview

ABOUT THE 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 two 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 2-3 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, rhinorrhoea, fever, decreased appetite, wheeze, lethargy and respiratory distress, with cough and rhinorrhoea 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 7-12 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 that 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 to 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 3-14 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 coming to the forefront as 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 4-5 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:S119-126.

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

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Collection & Shipping

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems Inc.
ImmuKnow is a registered trademark of Cylex Incorporated.
Respiratory Viral Panel is a product of Luminex Corporation.

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.