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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.

Abstracts & Publications

Aoki FY, Macleod MD, Paggiaro P, et al. Early administration of oral oseltamivir increases the benefits of influenza treatment. J Antimicrob Chemother. 2003;51(1):123-129.

Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000;38(8):2824-2828.

Bredius RG, Templeton KE, Scheltinga SA, et al. Prospective study of respiratory viral infections in pediatric hemopoietic stem cell transplantation patients. Pediatr Infect Dis J. 2004;23(6):518-522.

Byington CL, Castillo H, Gerber K, et al. The effect of rapid respiratory viral diagnostic testing on antibiotic use in a children’s hospital. Arch Pediatr Adolesc Med. 2002;156(12):1230-1234.

Carman WF, Mahony JB. The pathogens. J Clin Virol. 2007;40(Suppl 1):S5-S10.

Chakrabarti S, Collingham KE, Marshall T, et al. Respiratory virus infections in adult T cell-depleted transplant recipients: the role of cellular immunity. Transplantation. 2001;72(8):1460-1463.

Dare R, Sanghavi S, Bullotta A, et al. Diagnosis of human metapneumovirus infection in immunosuppressed lung transplant recipients and children evaluated for pertussis. J Clin Microbiol. 2007;45(2):548-552.

Edell D, Khoshoo V, Ross G, Salter K. Early ribavarin treatment of bronchiolitis: effect on long-term respiratory morbidity. Chest. 2002;122(3):935-939.

Elizaga J, Olavarria E, Apperley JF, et al. Parainfluenza virus 3 infection after stem cell transplant: relevance to outcome of rapid diagnosis and ribavirin treatment. Clin Infect Dis. 2001;(32):413-418.

Englund JA, Boeckh M, Kuypers J, et al. Brief communication: fatal human metapneumovirus infection in stem-cell transplant recipients. Ann Intern Med. 2006;(144):344-349.

Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003;163(4):487-494.

Fox JD. Respiratory virus surveillance and outbreak investigation. J Clin Virol. 2007;40(suppl 1):S24-S30.
Ginocchio CC. Detection of respiratory viruses using non-molecular based methods. J Clin Virol. 2007;40(Supp 1):S11-S14. 

Glanville AR, Scott AI, Morton JM, et al. Intravenous ribavirin is a safe and cost-effective treatment for respiratory syncytial virus infection after lung transplantation. J Heart Lung Transplant. 2005;24(12):2114-2119.

Gonzales R, Malone DC, Maselli JH, Sande MA. Excessive antibiotic use for acute respiratory infections in the United States. Clin Infect Dis. 2001;33(9):757-762.

Halasa NB, Williams JV, Wilson GJ, et al. Medical and economic impact of a respiratory syncytial virus outbreak in a neonatal intensive care unit. Pediatr Infect Dis J. 2005;24(12):1040-1044.

Hayden FG, Sable CA, Connor JD, Lane J. Intravenous ribavirin by constant infusion for serious influenza and parainfluenza virus infection. Antivir Ther. 1996;1(1):51-56.

Henrickson KJ. Cost-effective use of rapid diagnostic techniques in the treatment and prevention of viral respiratory infections. Pediatr Ann. 2005;34(1):24-31.

Influenza: the disease. Centers for Disease Control Web site. http://www.cdc.gov/flu/about/disease.htm. Published November 2004. Accessed November 2007.

Ison MG. Respiratory viral infections in transplant recipients. Antiviral Therapy. 2007;(12):627-638.

Ison MG, Hayden F, Kaiser L, Corey L, Boeckh M. Rhinovirus infections in hematopoietic stem cell transplant recipients with pneumonia. Clin Infect Dis. 2003;(36)1139-1143.

Kahn JS. Epidemiology of human metapneumovirus. Clin Microbiol Rev. 2006;19(3):546-557.

Kaiser L, Aubert J-D, Pache J-C, et al. Chronic rhinoviral infection in lung transplant recipients. Am J Respir Crit Care Med. 2006;(174):1392-1399.

Kim YJ, Boeckh M, Englund JA. Community respiratory virus infections in immunocompromised patients: hematopoietic stem cell and solid organ transplant recipients, and individuals with human immunodeficiency virus infection. Sem Resp Crit Care Med. 2007;(28):222-242.

Langley JM, Wang EEL, Law BJ, et al. Economic evaluation of respiratory syncytial virus infection in Canadian children: a Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) study. J Pediatr. 1997;131(1 Pt 1):113-117.

Larcher C, Geltner C, Fischer H, et al. Human metapneumovirus infection in lung transplant recipients: clinical presentation and epidemiology. J Heart Lung Transplant. 2005;24(11):1891-1901.

Lee I, Barton TD. Viral respiratory tract infections in transplant patients. Drugs. 2007;67(10):1411-1427.
Leland DS, Ginocchio CC.  Role of cell culture for virus detection in the age of technology. Clin Microbiol Rev. 2007;20(1):49-78.

Ljungman P, Ward KN, Crooks BNA, et al. Respiratory virus infections after stem cell transplantation: a prospective study from the Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. BMT. 2001;(28):479-484.

Mahony JB. The clinical need for the RVP test. J Clin Virol. 2007;40(Suppl 1):S36-S38.

Mahony J, Chong S, Merante F, et al. Development of a respiratory virus panel (RVP) test for detection of twenty human respiratory viruses using multiplex PCR and a fluid microbead-based assay. J Clin Microbiol. 2007;45(9):2965-2970.

Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med. 2005;353(13):1363-1373.

Ordas J, Boga J, Alvarez-Arguelles M, et al. Role of metapneumovirus in viral respiratory infections in young children. J Clin Microbiol. 2006;44(8):2739-2742.

Peck AJ, Corey L, Boeckh M. Pretransplantation respiratory syncytial virus infection: impact of a strategy to delay transplantation. Clin Infect Dis. 2004;(39):673-680.

Poehling KA, Edwards KM, Weinberg GA, et al. The underrecognized burden of influenza in young children. N Engl J Med. 2006;355(1):31-40. 

Raad I, Abbas J, Whimbey E. Infection control of nosocomial respiratory viral disease in the immunocompromised host. Am J Med. 1997;102(3A):48-52.

Robinson CC. The value of RVP in children’s hospitals. J Clin Virol. 2007;40(Suppl 1):S51-S52.

St. George K, Patel NM, Hartwig RA, et al. Rapid and sensitive detection of respiratory virus infections for directed antiviral treatment using R-Mix cultures. J Clin Virol. 2002;24(1-2):107-115.

Templeton KE. Why diagnose respiratory viral infection? J Clin Virol. 2007;40(Suppl 1):S2-S4.

Vilchez RA, McCurry K, Dauber J, et al. The epidemiology of parainfluenza virus infection in lung transplant recipients. Clin Infect Dis. 2001;33(12):2004-2008.

Vu D, Peck AJ, Nichols WG, et al. Safety and tolerability of oseltamivir prophylaxis in hematopoietic stem cell transplant recipients: a retrospective case-control study. Clin Infect Dis. 2007;(45):187-193.

Weinstock DM, Gubareva LV, Zuccotti G. Prolonged shedding of multidrug-resistant influenza A virus in an immunocompromised patient. N Engl J Med. 2003;348(9):867-868.

Wendt CH, Fox JM, Hertz MI. Paramyxovirus infection in lung transplant recipients. J Heart Lung Transplant. 1995;14(3):479-485.

WHO recommendations on the use of rapid testing for influenza diagnosis. World Health Organization Web site. http://www.who.int/csr/disease/avian_influenza/guidelines/RapidTestInfluenza_web.pdf. Published July 2005.  Accessed November 2007.

Woo PCY, Chiu SS, Seto W-H, Peiris M. Cost-effectiveness of rapid diagnosis of viral respiratory tract infections in pediatric patients. J Clin Microbiol. 1997;35(6):1579-1581.

xTAG™ RVP (Respiratory Viral Panel) Package Insert.