Research facility Testing Arrangements and Suggestions for the Up and coming Flu Season September 2, 2009

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Distinguish three research facility techniques to test quiet examples for flu. ... Suggestions given for lab squanders, sanitization and word related ...

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Research facility Testing Plans and Recommendations for the Upcoming Influenza Season September 2, 2009

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Presenters: Peter A. Shult, PhD. Chief, Communicable Disease Division & Emergency Laboratory Response , 608-262-5419 Dave Warshauer, PhD. Agent Director, Communicable Diseases , 608-265-9115 Carol Kirk Laboratory Network Coordinator , 608-262-1021

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Objectives At the end of the session, members will have the capacity to: Identify three research facility techniques to test tolerant examples for flu. Portray contemplations in the utilization and understanding of fast tests for flu. Outline gets ready for lab based observation of flu in Wisconsin amid the 2009-10 season .

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Brief Recap of Last Season Antigen Detection (Rapid) Testing Data Reported to WSLH, 2003/4 – 2008/9 Seasons Not an especially energizing year, until…

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Brief Recap of Last Season The "season" turned out to be all the more energizing in May Novel H1N1 PCR testing was performed at WSLH, Milwaukee Health Department Laboratory, Midwest Respiratory Virus Program, Marshfield Clinic Research Foundation

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Brief Recap of Last Season April 15, 2009 : CDC testing affirms 1 st human instances of novel H1N1 infection. April 17, 2009 : CDC testing affirms 2 nd human instance of novel H1N1 infection. April 23, 2009: 7 add up to cases - 5 instances of novel H1N1 affirmed in California; 2 cases in Texas. April 26, 2009: U.S. announces general wellbeing crisis . April 30, 2009: Per CDC - 91 add up to instances of novel H1N1 flu in: Arizona, California, Indiana, Kansas, Massachusetts, Michigan, Nevada, New York, Ohio, Texas. May 3, 2009: Per CDC – 226 aggregate cases in 30 states, including Wisconsin . June 11, 2009: W.H.O. raised the overall pandemic ready level to Phase 6. 

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Brief Recap: novel H1N1 Influenza Detected all through the State In Wisconsin: Confirmed Cases: 4,583 Probable Cases: 1,814 Total Cases: 6,397 Source:

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Brief Recap: Influenza Detections Continued through the Summer

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Expectations for 2009-2010 Season Probable (?) coursing infections Seasonal Influenza infections (in the immunizations) Influenza A (H1N1) - A/Brisbane/59/2007 (H1N1) Influenza A (H3N2) - A/Brisbane/10/2007 (H3N2) Influenza B - B/Brisbane/60/2008 (B/Victoria heredity) Novel H1N1 Influenza An infection Influenza A/California/07/2009 (H1N1) Concerns: Novel H1N1 Influenza An infection could transform into a frame that would bring about more serious disease. Antiviral defenselessness examples could change.

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Expectations for 2009-2010 Season Purpose of expense absolved testing amid Spring 2009 reaction was case recognizable proof Purpose of charge excluded testing amid 2009-2010 season is reconnaissance . WSLH will cease expense for-administration testing

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Laboratory-Based Influenza Surveillance in Wisconsin

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Expectations for 2009-2010 Season Objectives of flu reconnaissance Determine when flu infections are coursing * Determine where flu infections are circling * Track geographic spread of flu Track flu related disease Measure the effect of flu on genuine sickness and mortality Detect changes in flu infections * Infection by novel infections * Optimize utilization of immunizations and antivirals * = reliant on research facility commitments

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Components of Wisconsin's Laboratory-Based Influenza Surveillance Virology Laboratories (~11) PCR Laboratories (? number) Sentinel Submitters (~30) Rapid Test Sites (~145) WSLH Public Health Epidemiologists Laboratories Clinicians WSLH = Wisconsin State Laboratory of Hygiene

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Laboratory-Based Influenza Surveillance During 2009-10 Season Sentinel Submitters: ~ 30 enlisted human services suppliers give predetermined number of examples to WSLH. Virology (culture) Laboratories: ~ 11 research facilities give week by week reports and chose viral detaches. PCR Laboratories: ? Research centers give week after week reports and chose positives.

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Laboratory-Based Influenza Surveillance During 2009-10 Season Rapid Test (antigen recognition) Sites: Sites give week by week reports and chose tests to WSLH. 20 selected "Organized" accommodation destinations to send initial 5-10 every week ( paying little respect to quick test outcome ) These locales will be particularly enlisted and selected. Other quick test locales to send first positives, until told to stop. Notification will be given in Virus Surveillance Reports, WCLN Laboratory Messages and posted on the WSLH site. Demands for examples and notification to stop entries will be founded on local movement.

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Laboratory-Based Influenza Surveillance During 2009-10 Season Fee-absolved testing criteria for novel flu A (H1N1): Pregnancy Child 2 years old or less Healthcare Worker Resident or Staff of Residential or Correctional Facility Hospitalization Death Public Health Department Approval

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Laboratory-Based Influenza Surveillance During 2009-10 Season Note: " Positive fast flu A test outcome " is no longer included as a programmed foundation for fee–exempt testing, however … Fee-excluded corroborative testing of quick flu A test outcomes will be accessible (pretty much as in earlier years), yet will be suspended in every district in view of action.

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Laboratory-Based Influenza Surveillance During 2009-10 Season Packet of data , including shapes & directions, will be given to viral culture, PCR, & fast test destinations (as in earlier years). Will likewise present parts on the WSLH site Web-based reporting is accessible for fast testing locales; directions will be in the parcel.

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Laboratory-Based Influenza Surveillance During 2009-10 Season New structures will be given in bundles and presented on WSLH site. "Fillable" order shape for novel H1N1 reconnaissance will be posted on the WSLH site. It would be ideal if you finish submitter data before printing.

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Laboratory-Based Influenza Surveillance During 2009-10 Season Updates and reports will be given by means of WCLN research facility message, WSLH Virus Surveillance Report, and site. State and territorial diagrams for Culture, PCR, & antigen identification will be presented on the WSLH site – tap on "Reconnaissance Reports" at

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Laboratory-Based Influenza Surveillance During 2009-10 Season Teleconferences and online classes will be held as required. Yearly flu redesign video chat will be given in October.

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Influenza Testing

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Molecular Testing at WSLH and MHD CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel [rRT-PCR Flu Panel (IVD)] FDA-cleared Available to Public Health Labs Universal flu A location Subtypes Seasonal A/H1 Seasonal A/H3 A/H5 (Asian ancestry) Universal flu B discovery

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Molecular Testing at WSLH and MHD rRT-PCR novel A/H1 Flu Panel FDA-EUA Universal flu An identification Subtypes novel A/H1 Detects novel H1 lattice quality Novel H1 hemagglutinin quality

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Acceptable Specimen Types Upper respiratory tract Nasal or naso-pharyngeal (NP) swabs Throat swabs NP suctions or washes Lower respiratory tract Tracheal suctions Bronchoalveolar lavages Store at 2-8°C < 72 hours or stop at < - 70°C. Transport with cool-pack

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Reporting Possible results for the rRT-PCR novel A/H1 Flu Panel No flu A Virus RNA recognized Influenza A H1 (Swine-like) Virus RNA identified Influenza A Virus RNA distinguished; NOT H1 (Swine-like) Influenza A Virus RNA recognized; ambiguous for H1 (Swine-like) Influenza A Virus RNA identified; not able to subtype as H1 (Swine-like)

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Surveillance Testing Algorithms at WSLH Early season (low commonness) Screen for flu An and B If influenza A + → Subtype novel A/H1, regular A/H1, A/H3 Surge calculation if novel A/H1 prevails Run novel A/H1 influenza board Flu A +, novel H1 + = novel A/H1 Flu A +, novel H1 - → Subtype sA/H1, sA/H3 Test for influenza B in view of epidemiologic need if B coursing

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Surveillance Testing Algorithms at WSLH Super Surge with novel A/H1 prevailing Test for influenza An exclusive Report with remark that novel A/H1 is prevail flu An infection circling Continue reconnaissance for non-novel A/H1 on a subset of examples Store examples for testing post-flare-up

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Surveillance Testing Algorithms at WSLH- - Other Respiratory Viruses Throughout the season test a subset of influenza A negative examples for other respiratory infections Use a RVP that identifies 17 viral targets Approximately 40% of flu A negative examples are sure for other respiratory infections

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Surveillance for hostile to viral Resistance Screen for adamantane and oseltamivir (Tamiflu®) resistance Pyrosequencing Test for nearness of changes that present resistance M2 quality for adamantanes NA quality for oseltamivir

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Commercial Molecular Influenza Assay Options* Focus Laboratories - Influenza A H1N1 (2009) FDA-EUA ongoing PCR Differentiates novel H1N1 from occasional ABI 7500 MagNA Pure LC extraction Prodesse - ProFlu-ST FDA-EUA pending constant PCR Differentiates novel H1N1 from occasional SmartCycler MagNA Pure LC or NucliSENS easyMAG * WSLH does not underwrite the utilization of any business items. This rundown is accommodated instructive purposes just .

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Commercial Influenza Options Luminex xTAG RVP Detects novel H1N1, yet can't recognize the subtype Influenza A +, occasional H1 - , H3 – Influenza An unsubtypeable Possible novel A H1 Other items in different phases of advancement

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Laboratory Developed Molecular Tests ASR reagents are accessible Validation WSLH will give a board of examples at an ostensible cost to help with approval of