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Public Health Challenges in Influenza Diagnostics.pdf

Public Health Challenges in Influenza Diagnostics.pdf

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Influenza Diagnostics
Influenza Diagnostics

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Public Health Challenges in Influenza Diagnostics

Julie Villanueva, PhD Acting Chief, Virus Surveillance and Diagnosis Branch, Influenza Division, NCIRD Centers for Disease Control and Prevention June 13, 2013

Outline
 Influenza: Impact in the U.S.  Characteristics and challenges of rapid influenza diagnostic test (RIDT) use  2010 public health initiative to improve RIDT use  New challenges for RIDTs

000 influenza-related hospitalizations/year  Estimated by modeling studies using retrospective data and influenza surveillance data  Children  High rates in young children <2 years  Children 2-5 years next highest  High rates for children with chronic high-risk conditions  Adults  Highest rates in persons >65 years  High rates in persons with chronic illness http://www.)  Average of >200.gov/flu/weekly/ .S.Hospitalizations Attributable to Influenza (U.cdc.

other chronic conditions  Mortality data limited for children  Estimated average of 92 influenza-related deaths among children aged <5 years annually  34 deaths during 2011-2012 season. 150 during 2012-2013 to date http://www.349 to 48.)  Estimated average of severity is variable  3.Seasonal Influenza-associated Mortality (U.S.cdc.614 influenza-attributable deaths/year (1976-2007)  Highest mortality rates  Persons >65 years  Persons with chronic pulmonary and cardiac disease.gov/flu/weekly/ .

http://www.cdc.gov/flu/weekly/ .

cdc.http://www.gov/flu/weekly/ .

Medicare reimbursement claims from 2000-2011 for influenza diagnostic tests *Unpublished data compiled according to the Centers for Medicare and Medicaid Service (CMS) Current Procedural Terminology (CPT) codes .

Viral Culture (in public health laboratory or reference lab) .Influenza Diagnostic Dilemma Lab-confirmed diagnosis at public health lab or CDC Clinical assessment & preliminary clinical diagnosis of ILI specimens results RIDTs RIDTs & DFA (CLIA-waived) (in central clinical lab) PCR. Viral Culture (in central clinical lab) PCR.

156: 500-511 ..2% More sensitive for influenza A than influenza B Lower sensitivity in adults than in children Chartrand et al.3% .highly heterogeneous Specificity 98.Rapid Influenza Diagnostic Test Characteristics  Detection of influenza nucleoprotein (NP) using specific antibodies/antibody combinations  Can obtain results within 15 min. Annals of Internal Medicine 2012. and are available to clinicians during the time of a patient’s office visit  Extremely variable performance reported  Sub-optimal sensitivity reports in previous years  2012 Meta-analysis of 159 studies that compared RIDTs to a reference standard (RT-PCR or culture)     Sensitivity 62.

Hospitalized patients – Decisions to initiate antiviral treatment – Decisions to pursue other diagnostic testing – Decisions on infection control needed  Public Health  Control of suspected outbreaks in semi-closed settings – Decisions to initiate prevention and control measures for acute respiratory disease outbreaks of suspected influenza .Use of RIDTs  Clinical decisions  Testing decisions are linked directly to clinical decisions related to antiviral treatment and clinical management of individual patients  Outpatient. Emergency Room settings.

Challenges with RIDT Use  Clinicians may not access or utilize influenza surveillance data on the prevalence of influenza activity in their patient populations  Clinicians may lack understanding of key test parameters that influence RIDT results  Sensitivity and specificity  Prevalence  Major determinant of predictive values of influenza tests  Positive Predictive Value is highest and Negative Predictive Value is lowest during peak influenza activity  Negative Predictive Value is highest and Positive Predictive Value is lowest during low influenza activity .

and the impact of RIDT results on subsequent treatment decisions.  A positive RIDT result was a major reason among greater than two thirds of participants for prescribing antiviral medications  This was >3 times higher than the % OFP that ordered antiviral medications based upon other lab-based influenza tests.RIDT Use and Antiviral Prescriptions in Outpatient Settings  Survey of healthcare providers in outpatient facility providers (OFP) in 2008 and 2010 to assess their RIDT testing practices. the use of confirmatory testing.  OFP relied on RIDT for antiviral and antibiotic treatment decisions Unpublished results 2011 – CDC and Joint Commission .

Confirmatory Test Ordering from Outpatient Facility Providers 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% CHCs 2008 CHCs 2010 EDs 2008 EDs 2010 POs 2008 POs 2010 Positive Specimens Negative specimens Outbreak Settings (2010 only) Do not use Confirmatory Testing Emergency Departments (ED) Community Health Centers (CHC) Physicians Offices (PO) Unpublished results 2011 – CDC and Joint Commission .

NY (adjacent to Queens NYC)  “Emergency Department inundated with swine flu requests”  “Many patients admitted from the ED with an ILI/pneumonia were not put on influenza precautions because the rapid influenza A test was negative” – HCWs. pts & visitors exposed  “The most critical problem was the inability to get RT-PCR performed by the Health Department”  “Overdiagnosing and misdiagnosing. quickly became apparent”  “Health Department overwhelmed.31:102-4 SUNY Stony Brook . Cohan.View from the Clinician – 2009 Pandemic Cunha. results took more than a week”  Began using clinical criteria for infection control and clinical management .Mineola. Infect Control Hosp Epidemiol 2010. Thekkel.

2010 Public Health Initiatives Stakeholder meeting was held in September 2010 to help identify tools and resources for achieving:  Better practices for optimal use of RIDTs  Better guidance with relevant information for clinicians and laboratories  Better tests available to clinicians and laboratories Goal: To improve the use of RIDTS for clinical management and public health practice .

 Better Tests  Identify factors which can lead to improved RIDTs.  What are the incentives and support needed from CDC. Professional organizations.  Discuss ways to improve and disseminate guidance to clinicians.  Discuss how all can facilitate optimal use of currently available RIDTs for clinical management of patients. . manufacturers.2010 Public Health Initiatives  Better Practice  Presentation of data collected by JCAHCO and CDC. and others. FDA. Manufacturers  Better Guidance  Presentation of draft updates to CDC test guidance.  HHS. professional societies. BARDA. CDC. FDA.

aspx  1519 participants to date  YouTube channel for Strategies for Improving Rapid Influenza Testing in Ambulatory Settings featuring instructional videos: http://www.org/siras.jointcommission.com/playlist?list=PLNQfL_CJ36fK08KEPjxu1Z KJn7GuFtn-N&feature=plcp  7950 views of specimen collection videos to date .Outcomes of 2010 Stakeholder Meeting: Better Practice  Created specimen collection training resources  Continuing education course: Strategies for Improving Rapid Influenza Testing in Ambulatory Settings: http://www.youtube.

Outcomes of 2010 Stakeholder Meeting: Better Guidance  Added new algorithms and narratives to CDC Influenza website  Flowcharts with testing algorithms:  When influenza is circulating  When influenza is NOT circulating  In outbreak investigation in institutions  Guidance on molecular diagnostics  Updated lists of FDA-cleared RIDTs and molecular assays .

Outcomes of 2010 Stakeholder Meeting: Better Tests  Evaluate clinical performance of current FDA-cleared tests in defined practice settings and communicate results effectively to the practice community on an annual basis  Support development and implementation of new or significantly improved RIDTs:  Research and development by manufacturers  Regulatory process innovations .

MMWR 2012. the Biological Advanced Research and Development Authority (BARDA) and the Medical College of Wisconsin (MCW) performed an analytical evaluation using RIDTs  All 11 commercially available FDA-cleared RIDTs (2010–11 influenza season)  23 recent influenza viruses to allow for a more finely detailed characterization of test performance  The analytical sensitivity of the evaluation varied across tests and with different influenza viruses  Each influenza virus had variable levels of positivity with RIDTs. 873-876 . suggesting that several viruses of each type and subtype should be evaluated with each RIDT on a regular basis  These findings do not reflect performance in clinical settings  Performance of any one test kit may appear more or less sensitive depending on the predominance of virus subtype during a clinical evaluation Beck et al.BARDA/CDC/MCW study  With CDC. Nov 2: 61(43)..

Benefits of Annual Analytical Assessment  Determine that recent circulating influenza viruses are detected  Determine an estimated level of analytical sensitivity  Utilize a standard set of fully characterized influenza virus preparations  Provide mechanisms for evaluating analytical reactivity with emerging influenza viruses .

New Challenges for RIDTs Influenza H7 Influenza H5 Influenza H3N2v Seasonal influenza Phylogenetic analysis of nucleoprotein genes of influenza viruses from various hosts .

Influenza H3N2v in Humans 2005-2011 16 14 Number of human cases 12 10 8 6 4 2 2 1 2 4 3 2 1 1 1 6 12 H3N2v M H3N2v H1N2v H1N1v 0 2005 2006 2007 2008 2009 2010 2011 .

Influenza A(H3N2)v: 2005 .September 2012 350 306 300 Number of human cases 250 200 150 100 50 0 2005 2006 2007 2008 2009 2010 2011 2012 H3N2v M H3N2v H1N2v H1N1v .

1111/irv. Influenza and Other Respiratory Viruses 2012. DOI:10..Analytical Assessment of RIDTs with H3N2v  Seven FDA-cleared RIDTs were tested with various concentrations of 2 seasonal and 10 variant influenza viruses  Large variation in performance with some tests detecting only one or two variant influenza viruses  One RIDT did not detect H1N1pdm09 influenza virus at high virus infectious titer  The findings do not represent clinical performance Balish et al.12017 .

New Challenges for RIDTs Influenza H7 Influenza H5 Influenza H3N2v Seasonal influenza Phylogenetic analysis of nucleoprotein genes of influenza viruses from various hosts .

Benefits of Reclassification to Public Health  Standardization of reference methods  Performance measurement equality  Monitoring of performance as seasonal influenza evolves  Early indication of potential performance issues  Mechanism to assess tests as novel influenza viruses emerge  Expeditious method to inform public health and clinical community in an emergency .

Benefits of Reclassification to Public Health  Heightened performance  Minimum performance criteria to reduce sensitivity issues  Introduction of advanced technologies  Encourage manufacturers to develop new methods and techniques to assist the clinician in making an informed decision regarding patient management .

Thank you .

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