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 Mission Pandemic 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

28. Modular BSL 3

29. Modular BSL 3

30. Modular BSL 3

31. Modular BSL 3

32. Modular BSL 3

33. Modular BSL 3

34. Modular BSL 3