Proposed Post Global Tuberculosis Strategy and Targets
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1 Proposed Post Global Tuberculosis Strategy and Targets Photo: Riccardo Venturi WHO recommenda-ons for biosafety in tuberculosis laboratories Dr Christopher Gilpin Global TB Programme World Health OrganizaDon, Geneva, Switzerland
2 Content overview Risk assessment and the classifica-on of TB laboratories Essen-al biosafety measures for TB laboratories Low- risk TB laboratories Moderate- risk TB laboratories High- risk TB laboratories (TB- containment laboratories) 2
3 What is Biosafety? The applica*on of a combina*on of administra*ve controls, containment principles, laboratory prac*ces and procedures, safety equipment, and laboratory facili*es to enable laboratorians to work safely with poten*ally infec*ous microorganisms
4 Risk Group Classifica-ons and which Biosafety Level (BSL) RISK GROUP CLASSIFICATION WORLD HEALTH ORGANIZATION LABORATORY BIOSAFETY MANUAL 3RD EDITION 2004* Risk Group 1 (No or low individual and community risk) A microorganism that is unlikely to cause human or animal disease. Risk Group 2 (Moderate individual risk; low community risk) A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. Where does TB fit? Risk Group 3 BSL 1?BSL 2 (High individual risk; low community risk) A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.? BSL 3 Risk Group 4 (High individual and community risk) A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.? BSL 4
5 Determining minimum biosafety measures AFB Microscopy remains the primary diagnos-c tool for the diagnosis of TB More than 37,000 microscopy laboratories in the 22 high- burden limited- resource serngs Rapid molecular tests (e.g. Xpert MTB/RIF) are being scaled- up in laboratories with minimal biosafety precau-on Other more sophis-cated tests are performed at regional or central laboratories Need for prac*cal guidance to countries to ensure at least the minimal precau*ons can be implemented in TB laboratories depending on which procedure is being performed using a risk assessment based approach
6 Current approaches are based on Bio- Risk Assessment Pathogenicity of the infec-ous agent Route of transmission Agent stability and infec-ous dose Concentra-on of agent Type of laboratory procedures to be done Availability of effec-ve prophylaxis or therapy Skill level and vulnerability of at- risk personnel (e.g. HIV infec-on) Epidemiology of TB
7 How to conduct risk assessment for TB laboratory Iden-fy the inherent hazards Decide who might be harmed and how Evaluate the risks and decide on precau-ons Record your findings and implement them Review your assessment and update it if necessary 7
8 WHO recommended diagnosdcs for use at different levels of laboratory sophisdcadon *Available at: h^p://
9 Biosafety (risk) Levels for TB Laboratories High- risk TB laboratory (TB- containment laboratory) Culture, DST, LPA (cultures) Moderate- risk TB laboratory liquifying (processing) samples Low- risk TB laboratory Microscopy, Xpert
10 Biosafety Guidance AFB Microscopy Limited risk of genera*ng infec*ous aerosols Work can be done on an open bench restricted access to the laboratory separate bench for smear- prepara-on Adequately ven-lated laboratory 6-12 ACH, direc-onal airflow Natural or mechanical ven-la-on Proper disposal of infec-ous material
11 Biosafety Guidance: Processing sputum specimens for culture inocula-on and/or direct molecular tests (1) Moderate risk of genera*ng infec*ous aerosols during centrifuga*on and specimen manipula*on Laboratories must have restricted access and be separated from public areas Impermeable surfaces for easy cleaning Air flows into lab without re- circula-on to non- lab areas (direc-onal airflow) 6-12 ACH, passive or mechanical ven-la-on closed windows All work MUST be performed within a cer-fied BSC Proper disposal of infec-ous material
12 Biosafety Guidance: Processing sputum specimens for culture inocula-on and/or direct molecular tests (2) Moderate risk of genera*ng infec*ous aerosols during centrifuga*on and specimen manipula*on Class I or II Biosafety Cabinet used for all open manipula-on of agents BSCs must be properly installed and cerdfied at least annually BSC exhaust may be ducted to outside using a hard duct or thimble firng recirculated into the room if assured that the BSC is func-oning properly Use aerosol- containment centrifuge rotors
13 Biosafety Guidance: Manipula-ng cultures for smear prepara-on, iden-fica-on tests, DST, or molecular tests High risk of genera*ng infec*ous aerosols during manipula*on of liquid suspensions Work done in a TB- containment lab which has restricted access and a double door entry Impermeable surfaces for easy cleaning sealing room for fumiga-on is not required Air flows into lab without re- circula-on to non- lab areas (direc-onal airflow) 6-12 ACH, mechanical ven-la-on, sealed windows Autoclave available on site
14 High- risk TB Laboratory TB containment laboratory Double door airlock Separate air inlet Ven-ng of BSC via thimble Aerosol containment Nega-ve pressure monitoring Uni- direc-onal airflow PPE Autoclave for waste disposal Necessary for performing culture and DST
15 Determining which precau-ons to use When non- standard procedures need to be performed it is the responsibility of laboratory director assesses poten-al risks for the work by performing a risk assessment and to determine what addi-onal precau-ons may be needed. Lab directors may specify more or less stringent prac-ces when informa-on is available to suggest altered risk e.g., increased precau-ons can be implemented for XDR TB cultures or staff at greater risk
16 Ques-ons? The TB containment laboratory
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