Laboratory Influenza Response

1. Laboratory Influenza Response Kerri Gerage Laboratory Emergency Response Coordinator Louisiana Office of Public Health Laboratory

2. Disclosure • I have no financial interests or other relationship with manufacturers of commercial products, suppliers of commercial services, or commercial supporters. My presentation will not include any discussion of the unlabeled use of a product or a product under investigational use.

3. Objectives • Describe the Office of Public Health Laboratory’s mission for Influenza Testing • Recognize the OPH Lab capabilities and capacity • Discuss acceptable sample types and proper shipping methods

4. Public Health MissionPandemic Influenza Testing • NOT Diagnostic Testing • Determine when and where influenza viruses are circulating • Determine how much influenza activity is occurring • Identify types and strains of circulating influenza viruses in addition to the pandemic strain • Monitor for mutations in the influenza virus strains • Detect unusual events: • Infection by unusual viruses • Unusual syndromes caused by influenza viruses • Unusual large/severe outbreaks of influenza • Increased mortality

5. Challenges NOT encountered THIS TIME • Limitations or absence of lab reagents, supplies, PPE, etc • Worker absenteeism (ie. personal illness, family issues, quarantine) • Disruptions of medical and community services • Need to suspend other critical lab services

6. Current Role in Influenza Testing • Tests human specimens for influenza virus year-round according to OPH guidelines: • Seasonal influenza surveillance (Sentinel providers) • Investigation of respiratory illness outbreaks (ID Epi) • Surveillance for novel influenza virus in humans • If case meets OPH and CDC clinical and epidemiologic criteria for possible novel influenza infection

7. OPH Laboratory Capabilities • Infrastructure available from ongoing preparedness efforts and planning • Dedicated molecular laboratories • Multiple real time PCR instruments and platforms • Experienced molecular and virology staff • 24 hours a day, 7 days a week emergency response capability • Influenza collection kits on hand

8. Overview of OPH Laboratory Testing FDA cleared – Emergency Use Authorization, CDC developed test for Influenza A, B, and for sub-typing H1, swH1, H3 (and if needed H5) All tests will be performed by real-time rt-PCR First five confirmed positive Influenza A swH1 specimens are referred to CDC for drug resistance testing each week

9. What has OPH Done to be Ready for Future Influenza Pandemics? We have cross-trained additional staff Added some additional equipment Will have additional clerical staff trained for data entry Rearranged the Laboratory to allow for more efficient work-flow

10. Additional Biological Safety Cabinets for Specimen Processing

11. Additional Automated Nucleic Acid Extraction Equipment

12. Additional Real Time PCR Equipment

13. How Was Testing Handled Differently in the OPH Laboratory in the Spring ‘09 and now? In the Spring - wide spread testing to characterize a new virus and its spread A large number of isolates were tested A large number of isolates were sent to CDC Currently - limited targeted testing as needed Representative isolates will be sent to CDC

14. How is Testing be Handled Differently in Clinical Laboratories FDA (Emergency Use Authorization) has cleared the first commercially available Influenza A swH1 assay for clinical use; others will follow Some Commercial Laboratories currently have non-FDA approved, CLIA compliant Influenza A swH1 kits Diagnostic test manufacturers are ramping up production of rapid test kits

15. Specimen Submissions Specimens will only be accepted from: Influenza Sentinel Submitters selected by the Infectious Diseases Epidemiology Program From hospitalized patients that meet the criteria set by ID Epidemiology No general population or clinical testing

16. Current Acceptable sample types • Nasopharyngeal swab:Tip of a polyester or Dacron swab placed in a transport vial containing 2.0ml of viral transport medium • Throat washing: 3-5 ml of sterile PBS gargled and placed in a transport vial containing 2.0 ml of viral transport medium • Throat swab: Tip of a polyester or Dacron swab placed in a transport vial containing 2.0 ml of viral transport medium • Nasal washing:3-7 ml of sterile PBS used to wash the patient’s nasal passage put into a sterile transport vial with viral transport medium • Nasal swab:Tip of a polyester or Dacron swab placed in a vial containing 2.0 ml of viral transport medium

17. Sample Collection • Samples must be collected using a Dacron, polyester, or rayon swab with a plastic or aluminum shaft • Specimens must arrive in sealable bag placed inside of an insulated cooler • Patient sample collection swabs must be placed in collection tubes with Viral Transport Media. Transport media must be specifically for viral transport. Media used to transport specimens for bacterial, fungal or parasite examinations are not acceptable • When collecting samples from a patient suspected of having H1N1, a new swab should be collected to send to the OPH Lab. Do not send the same swab that was used for the Rapid Test

18. How to submit a Specimen Place the swab in Viral Transport Media Make sure Viral Transport Media Has Not Expired Put the date and time of collection on the tube along with the patient’s name

19. Fill out the Submission Form Completely Incomplete forms delay testing Common Errors No Fax Number No time or date of collection Illegible

20. Packaging Flu Samples • Obtain a Category B mailer • Place frozen ice packs on the bottom of the Styrofoam ice chest • Place wet ice in a sealable bag on top of the froze ice packs • Place the sample in viral transport media in another sealable bag with absorbent material on top of the wet ice • Fill another sealable bag with wet ice to put on top of the samples • Place 2 more frozen ice packs on top of the wet ice

21. Ship to the OPH Laboratory Overnight in a Category B Mailer

22. Why all these details? Proper specimen collection, packaging and shipping ensure a quality specimen is analyzed Federal Regulators require that these procedures be followed. Non-compliance can result in fines and closure of the laboratories responsible

23. Who will get the Laboratory Results The following people all get the patient test results at the same time-as soon as they are verified Infectious Disease Epidemiology Person or Agency that Submitted the Specimen by Fax if the number is provided by mail if fax number is not provided

24. What Restrictions are there on Releasing Laboratory Results? HIPPA regulations require that patients health data be protected from disclosure Patients have to authorize the release of their lab results to third parties The OPH Laboratory will only release lab results to the submitter of record on the submission form without the patients permission The only exception is for public health use

25. Upcoming Changes to Influenza Testing FDA Emergency Use Authorization will expire soon Acceptable sample sources for testing may change Temperature requirements will expand from 2- 4° C to 2- 8° C The acceptable time frame for getting refrigerated samples to the lab will decrease from 96 hrs to 72 hrs

26. Upcoming Changes to Influenza Testing Letter will be faxed to all submitters explaining the changes Report terminology may change slightly

27. Additional Lab Space Installed a Modular BSL 3 Adds additional lab space Adds additional testing capablilities

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