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Laboratory training course: Proper selection, handling and shipping of samples for diagnosis of influenza and other respiratory viruses SESSIÓN 4: SELECTION, HANDLING AND CORRECT SHIPPING OF SAMPLES Objectives • Know criteria for selection and characterization of samples • Review the guidelines for sending samples to WHO CC • Review basic concepts of packing and shipping samples • Know the requiered documentation for sending samples http://www.livescience.com/16382-viruses-raw-sewage.html What Information is Important about Influenza Viruses? • Emergence of novel subtypes • Mutations among circulating viruses • Increasing incidence/emergence of antiviral resistance among circulating viruses • Comparison of circulating viruses to viruses in current seasonal vaccine How can we resolve these questions? To answer these questions it is necessary to have different laboratory tests and tools for identification. Some are available at the NICs and others are performed the WHO CC, among which are the following: • • • • • • • Inmunofluorescence Viral Isolation (MDCK and Embryonated Eggs) Titration of HA and IHA (Antigenic Characterization) Microneutralization Typing and subtyping by qRT-PCR Pyrosequencing and Sequencing Bioinformatics analyzes National Influenza Centers http://www.who.int/influenza/gisn_laboratory/national_influenza_centres/t erms_of_reference_for_national_influenza_centres.pdf WHY, WHERE AND FOR WHAT SEND SAMPLES? Why? Because of the capacity of transmission and evolution of influenza viruses, it is necessary to complement monitoring by more detailed characterization of circulating viruses Where? Regional Labs to NICs NICs to WHO CC WHO CC shares information and viruses with the Global Influenza Surveillance Network ) For What? Selection of strains for vaccine formulation Antiviral Resistance WHO-CC Novel Virus Mutation detection CRITERIA FOR SELECTION OF SAMPLES Samples for the WHO-CC Objective How to Select Samples Detect novel subtype Any unsubtypeable influenza A virus Detect anti-viral resistance Cases receiving antiviral therapy, immunosuppressed cases Detect mutations Random Contribute to vaccine composition Random When to Send Samples Funding Source to Ship Samples Immediately Routine (2-4 times each year) Number of samples is according to epidemiological presentation Number of samples is between 15 to 20 Based upon influenza season and by August and January 15 WHO Global Shipping Project, PAHO, CDC, Country Resources Random Selection • • • • • • • All circulating virus types/subtypes Different age groups Varying geographic regions Ambulatory and hospitalized cases Deaths Outbreaks Recipients of antiviral therapy Other criteria - 5 to 10 representative samples of unusual outbreaks (e.g. outside the expected seasonal) - Any sample corresponding to unusual cases with inconclusive results Sending at any time Additional Principles in Selecting Samples to Submit • Type of sample to send isolates preferred, also send clinical material • Time period to select from recent viruses (1-3 months old) Objective 1: Detect Novel Subtype • Which samples to send: any influenza A virus which is unable to be subtyped • When to send: immediately • Public health significance – Emergence of novel subtype with pandemic potential – Introduction of H5 or H7 in the Americas Region Objective 2: Detect Anti-viral Resistance • Which samples to send – Prioritize • Cases receiving anti-viral therapy • Cases who are immunosuppressed – Part of random selection of 15-20 samples • When to send – Routinely (2-4 times each year) • Public health significance – Emergence of anti-viral resistant strain – Fewer options for treatment/chemoprophylaxis Objective 3: Detect Mutations • Which samples to send – Part of random selection of 15-20 samples • When to send – Routinely (2-4 times each year) • Public health significance – Poor vaccine match Objective 4: Contribute to Vaccine Composition Development • Which samples to send – Part of random selection of 15-20 samples • When to send – Routinely (2-4 times each year) – Before strain selection meeting (February, September) • Public health significance – Data needed to determine which three/four strains to include in the seasonal influenza vaccine Seasonal Influenza Vaccine • Trivalent or quadrivalent vaccine – Influenza A (H1) – Influenza A (H3) – Influenza B (Yamagata and/or Victoria) • Southern Hemisphere and Northern Hemisphere composition – Southern Hemisphere composition determined in September – Northern Hemisphere composition determined in February – Recommendations match ~66% of the time When to Send for Routine Submission NH STRAIN SELECTION SH STRAIN SELECTION MEETING MEETING SH INFLUENZA SEASON JAN FEB MAR APR MAY JUN JUL AUG NH INFLUENZA SEASON SEPT OCT NOV DEC NH INFLUENZA SEASON TROPICAL COUNTRIES INFLUENZA SEASON When to Send for Routine Submission- Southern Hemisphere NH STRAIN SELECTION SH STRAIN SELECTION MEETING MEETING SH INFLUENZA SEASON JAN FEB MAR APR MAY JUN JUL AUG Offseason Earlyseason SEPT OCT NOV DEC Midseason Lateseason When to Send for Routine Submission- Tropical Countries NH STRAIN SELECTION MEETING SH STRAIN SELECTION MEETING JAN FEB MAR APR MAY JUN JUL AUG Offseason Earlyseason SEPT OCT NOV DEC Midseason Lateseason Santa Cruz, Bolivia Chile When to Send for Routine Submission Meeting for the formulation of the vaccine SH NH Selection and sending Samples Muestras sentenviadas to WHO CC a los forCC additional OMS para characterization caracterización byadicional date received por fecha and by recibida country, y por 2014 país, 2014 NH Source: WHO CC data. Note: Each color represents one country. SH Samples sent to WHO CC for additional characterization by Region and month received, 2014 Source: WHO CC data. SENDING SAMPLES Transport of Dangerous Goods International Regulations UN Committee of Experts on the Transport of Dangerous Goods (UNCETDG) Transport of dangerous goods International Regulations Air Rail • The International Air Transport Association (IATA) • Regulations concerning the International Carriage of Dangerous Goods by Rail (RID) Road • The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) Sea • The International Maritime Dangerous Goods Code published by the International Maritime Organization (IMO) Consequences of improper packaging Exposure to infectious substances Errors and delays in delivery Difficulting finding transport Panic incident Consequences Civil or criminal lawsuits Shipment detained by customs Sender responsibilities Coordinate with carrier and receiver Responsibility of the sender Complete documentation Ensure Clasification of the substance Label Packaging Good to know… -Categorization -appropriate packaging -appropriate labeling -Documentation Required -Format Air Shipping -Statement of dangerous goods (A) -Certificate Training Categorization Classes of Dangerous Goods • Class 2: Gases • Class 3: Flammable liquids • Class 6: Toxic and infectious substances Division 6.1: Toxic substances Division 6.2: Infectious substances • Class 9: various dangerous goods and articles, including environmental substances Substances class 6 Class 6: Toxic and Infectious substances Division 6.2: Infectious substances 1. 2. 3. 4. 5. 6. 7. 8. Infectious substances (Category A) Biological substances (Category B) Biological products Genetically modified organisms Clinical or Medical wastes Live and infected animals Human samples/animal samples exemptions Other exemptions Categorization (Division 6.2) CATEGORY A • Any infectious substance that could generated disability, life threatening or fatal disease in healthy humans or animals Proper shipping name: UN 2814 "INFECTIOUS SUBSTANCE, AFFECTING HUMANS" UN 2900 "INFECTIOUS SUBSTANCE, AFFECTING ANIMALS ONLY" CATEGORY B • Any biological substance that does not meet the criteria for Category A. Proper shipping name : UN 3373: "BIOLOGICAL SUBSTANCE, CATEGORY B" A 3291: "CLINICAL WASTE, UNSPECIFIED" Flow for the classification of infectious substances http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Categorization (division 6.2) • Category A (Infectious Substances) • Category B (Biological Substances) • Exemptions: 1. Samples without infectious components or with low probability of causing disease in humans or animals 2. Substances with non-pathogen agents for humans or animals 3. Neutralized or inactivated substances Categorization (division 6.2) • Category A (Infectious Substances) Highly pathogenic avian influenza virus (viral culture) • Category B (Biological Substances) Highly pathogenic avian influenza virus (patient sample) • Exemptions: 1. Samples without infectious components or with low probability of causing disease in humans or animals 2. Substances with non-pathogen agents for humans or animals 3. Neutralized or inactivated substances Some infectious goods included in category A Packaging Packaging • Use three layers of packaging • The first container must be resistant to seepage • Use absorbent material in each container Primary container Secondary container http://upload.wikimedia.org/wikipedia/commons/2/28/Tripe_embalaje.png Outer container Packaging Category A http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Packaging Category A http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.1 2_eng.pdf?ua=1 • All Category A infectious substances must comply with the instructions for packaging the United Nations (UN), P620 . • This guarantees the packaging has passed stringent stress tests (pressure, stacking, punching, etc.) • The outer container must indicate the sign of the United Nations, ensuring quality packaging to officials Labeling Category A Labeling Category A Information on the outer container : • Name and address of the sender • Telephone number responsible for shipping • Name and address of consignee • Proper shipping number (UN 2814 or UN 2900) • Temperature requirements (optional) • If dry ice or liquid nitrogen is used: technical name, UN number and total amount. http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.1 2_eng.pdf?ua=1 Labeling Category A http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Labeled Category A http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Labeled Category A http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Packaging Category B http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Labeled Category B Each shipment must have the following information : http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 • Airway: name, phone number and address of the sender • Phone of person responsible for emergency contact • Name, telephone number and address of the recipient . • Proper name, visible: (“BIOLOGICAL SUBSTANCE, CATEGORY B") • Optional: Special requirements for temperature Documentation of Category B Air waybill: • A packing list format or the address of the consignee, the number of packages to send, weight and detail of the content. • Declaration or import/export permit (if required). • Sending Format (air waybill) where the content is detailed http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.12_eng.pdf?ua=1 Documentation of Category B These documents must be prepared and signed by the sender: Declaration of Dangerous Goods • Declaration of Dangerous Goods • A packing list format or the address of the consignee, the number of packets to send, weight and detail of the content. • Declaration or permit import/export (if required). • Appropriate documents (waybill) for shipments by rail, road or sea. http://apps.who.int/iris/bitstream/10665/78075/1/WHO_HSE_GCR_2012.1 2_eng.pdf?ua=1 Documentation of Category B Declaration of Dangerous Goods Final recomendations… • Ensure cold chain. • Include details of sending samples, identification number and epidemiological data References Blanton,L., Brammer,L., et al.(2011) Influenza. Manual for the surveillance of vaccinepreventable diseases. 5th Edition. Available online at: http://www.cdc.gov/vaccines/pubs/surv-manual/chpt06-influenza.pdf World Health Organization (WHO). (2006) Collecting, preserving and shipping specimens for the diagnosis of avian influenza A(H5N1) virus infection. Guide for field operations. Available online at: http://www.who.int/csr/resources/publications/surveillance/CDS_EPR_ARO_2006_1.pdf?ua= 1 World Health Organization (WHO). (2004) Guidelines for the collection of clinical specimens during field investigation of outbreaks. Available online at: http://www.who.int/csr/resources/publications/surveillance/whocdscsredc2004.pdf World Health Organization (WHO).(2009) Instructions for storage and transport of suspected or confirmed human and animal specimens and virus isolates of pandemic (H1N1). Available online at: http://www.who.int/influenza/gisrs_laboratory/logistic_activities/transport_storage_specimens _isolates/en/ References (2) World Health Organization (WHO). Laboratory biosafety manual, Biosafety guidelines. Third Edition (2004). Available online at: http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1 World Health Organization (WHO). Manual for the laboratory diagnosis and virological surveillance of influenza. Available online at: http://whqlibdoc.who.int/publications/2011/9789241548090_eng.pdf?ua=1 World Health Organization (WHO). Nasopharyngeal and Oropharyngeal Swabs. Available online at: http://www.youtube.com/watch?v=mfZYAMDpGNk World Health Organization (WHO). Selection of clinical specimens for RT-PCR and virus isolation and of viruses for shipment from National Influenza Centres to WHO Collaborating Centres. Available online at: http://www.flu.mn/mgl/images/stories/Sudalgaa_shinjilgee/GISN2010/suppl.03.%20Selection%20on% 20clinical%20specimens%20for%20PCR,%20virus%20isolation%20and%20shipment%20for%20NIC s.pdf World Health Organization (WHO). WHO information for molecular diagnosis of influenza virus in humans – update (2012). Available online at: http://www.who.int/influenza/gisrs_laboratory/molecular_diagnosis_influenza_virus_humans_update_2 01211.pdf World Health Organization (WHO). Personel Protective Equipment (PPE). Available at: World Health Organization (WHO). Thank you!
