Laboratory Results and Operations in WHO Phase 6 Dr. Attaporn Taweetungtragoon CYBELES Phnom Penh, Cambodia October 12-15, 2009

Background  The Protocols are based on Detection, Investigation, and Reporting  Rapid Response and Containment  The strategy is geographically based  Containment and Buffer zone operations include Surveillance and on going laboratory testing Surveillance and on going laboratory testing Containment communications Containment communications Antiviral administration Antiviral administration

Containment/Buffer Zone Checklist  Identification of Laboratories  Field Response Teams  Sample Collection  Specimen testing and reporting  Specimen shipping  Specimen storage  Logistical support

Early Detection and Rapid response  Reliable Laboratory testing can provide resource focus, disease patterns, and patient contact/education  Buffer zone testing is also indicated as part of the Surveillance program  Buffer zone lab testing will continue as long as the containment is on going  Containment and Buffer Zone key tasks --Extensive antiviral prophylaxis and treatment -- Surveillance and LABORATORY --Extensive antiviral prophylaxis and treatment -- Surveillance and LABORATORY TESTING TESTING --Assessment of the novel virus --Assessment of the novel virus

What do we need for setting up PCR/ qRT-PCR lab for Flu tests Instruments Supplies Cold reagents Room temperature supplies Well trained lab staffs

Illustrated PCR Workflow Prepare the RNA template Extraction of Nucleic Acid (RNA/DNA) Prepare the RT-PCR reactions Run the experiment Design and set up PCR experiment Amplification plot Interpretation of the result Manual RNA extraction Automatic extraction System Software

RNA /DNA Extraction Systems Small Scale Extraction System (8 samples/run) Big Scale Extraction System (96 samples/run)

Variety of PCR and Real-Time RT-PCR Instruments Small scale laboratory InstrumentPCR Big scale laboratory instrument Real-Time PCR SENSOQUEST

Real-Time RT-PCR System Software

Interpretation of Results Target Pathogen Internal control Negative control Positive control Interpretation POS NEGPOS NEGPOSNEGPOSNEG INVALID POS INVALID

Sample collection methods are poor Sample collection methods are poor Lack of refrigeration in shipping and storage process Lack of refrigeration in shipping and storage process RT-PCR testing done incorrectly RT-PCR testing done incorrectly Positive results are not identified Positive results are not identified Results are not reported in a timely manner Results are not reported in a timely manner Results are not numbered and stored correctly Results are not numbered and stored correctly Leaders do not understand the meaning of the results because they are not displayed correctly Leaders do not understand the meaning of the results because they are not displayed correctly The results are not acted in time because the leaders do not understand how important the results are. The results are not acted in time because the leaders do not understand how important the results are. What can go wrong with Laboratory results?

WHO Laboratory Confirmation Laboratory in Cambodia Laboratory in Cambodia The WHO Representative in Cambodia No corner Streets Pasteur (51) and 254 PO Box 1217 Phnom Penh Cambodia The WHO Representative in Cambodia No corner Streets Pasteur (51) and 254 PO Box 1217 Phnom Penh Cambodia Laboratory in Thailand Laboratory in Thailand The WHO Representative Soi Bamrasnaradoon, Permanent Secretary Building 3, 4th Floor Tiwanond Road Nonthaburi The WHO Representative Soi Bamrasnaradoon, Permanent Secretary Building 3, 4th Floor Tiwanond Road Nonthaburi Thailand Laboratory in Japan Laboratory in Japan WHO Technology Transfer Programme Office c/o International Medical Centre of Japan Toyama, Shinjuku-ku Tokyo JAPAN WHO Technology Transfer Programme Office c/o International Medical Centre of Japan Toyama, Shinjuku-ku Tokyo JAPAN Host Nation Laboratory that is Ministry of Health operated Host Nation Laboratory that is Ministry of Health operated

Laboratory Testing and preparedness  Testing all suspected cases is preferred but may not be possible  Potential large numbers will be tested if Containment operations are initiated requiring local, state and federal coordination  Equipment and consumable supply requirements  WHO collaborating centers and other reference Labs will perform molecular and genetic studies

National Pandemic planning for Laboratory operations Identify all Laboratories in the country and list their capabilities Identify all Laboratories in the country and list their capabilities Identify Labs that can perform Novel virus testing Identify Labs that can perform Novel virus testing Test all Laboratory proficiencies annually with WHO Test all Laboratory proficiencies annually with WHO Work with WHO as a regional partner Work with WHO as a regional partner

Laboratory Field Response Teams Establish fast response Laboratory teams (May include military component) Establish fast response Laboratory teams (May include military component) Must have vaccinations, passports Must have vaccinations, passports Team members must have training in influenza diagnostics, safe specimen handling, and dangerous goods packaging & shipping Team members must have training in influenza diagnostics, safe specimen handling, and dangerous goods packaging & shipping National authorities must stockpile adequate PPE, specimen collection and transportation materials, and swabs. National authorities must stockpile adequate PPE, specimen collection and transportation materials, and swabs.

Specimen Collection, Shipping, Reporting, & Storage Develop a consistent and systematic method to label specimens that links them to patients and epidemiological data. Develop a consistent and systematic method to label specimens that links them to patients and epidemiological data. Ensure import and export documents are in place in advance. Ensure import and export documents are in place in advance. Determine which staff can interpret and report the results. Determine which staff can interpret and report the results. Develop a plan & capacity for storing representative specimens, isolates, and nucleic extracts for research and evaluating mutations Develop a plan & capacity for storing representative specimens, isolates, and nucleic extracts for research and evaluating mutations

Summary  Laboratory testing is on going from pre pandemic to recovery  Supplies and equipment must be utilized in training activities  Field and in-house Lab testing is a critical component of Containment and Buffer zone operations  Laboratory testing will determine effectiveness of operations and drive decision-making at all levels