Medical reference laboratory providing esoteric and genetic testing services, test selection guidance, result interpretation references, and continuing education for clients worldwide. Manual, the us biosafety in microbiological and biomedical laboratories, and the international consensus document cen workshop agreement cwa 15793. The results are used for population monitoring of hpv. Laboratoryspecific biosafety manual checklist each laboratory is required to have a labspecific biosafety manual and cannot be borrowed or copied from another lab. Dec 07, 2010 as a followup to the november 30 biosafety presentation, a rudimentary, workinprogress version of the laboratory biosafety manual has been posted on the research integrity and compliance website. In the united states, the centers for disease control and prevention cdc have specified these. Hpv testing has limited utility in patients at high risk for anal cancer, but. The maximum containment laboratory biosafety level 4 6. A biosafety level bsl, or pathogenprotection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. Chronic viral diseases branch division of highconsequence pathogens and pathology national center for emerging and zoonotic. Human papillomavirus laboratory manual, 1st ed 2009.
The authors and editor of this revised second edition continue the nowestablished who tradition of. Who consultation on technical and operational recommendations for scaleup of laboratory services and monitoring hiv antiretroviral therapy in resourcelimited settings. Human papillomavirus laboratory manual first edition, 2009 whoivb10. A laboratoryacquired infection is known or suspected, or b. Emmett barkley, howard hughes medical institute, chevy chase, md, usa dr murray l. Bsl basic biosafety level bpv bovine papillomavirus c centigrade. General precautions must be followed as outlined in the ccid safety manual cdc. The editors were dr elizabeth r unger, global who hpv reference laboratory.
International hpv reference center karolinska institutet. A laboratory acquired infection is known or suspected, or b. A laboratoryspecific biosafety manual must be prepared and adopted as policy. This document serves as the biosafety manual for the following. Who laboratory manual for the examination of human semen and spermcervical mucus interaction. Who laboratory manual for the examination and processing. Video links from the regulatory biosafety for plant research symposium held on april 2010 at uf are. For the manual pipetting of controls and specimens, use individual pipette tips to eliminate carryover of samples.
Vaccine development and global introduction 20052010. At the who 59 th ecbs meeting, 17 october 2008, the first is for hpv 16 dna was adopted with an assigned potency. The bivalent hpv vaccine is licensed for 925 year old females, and the quadrivalent hpv. English immunization, vaccines and biologicalsccines and. General emergency contact information the first page of the laboratory safety manual should include the following information so that it is quickly and easily accessible. Laboratory biosafety levels unc gillings school of global. Human papillomavirus laboratory manual first edition, 2009 34 4. Human papillomavirus laboratory manual world health organization. Good microbiological technique and appropriate use of biosafety equipment by welltrained staff remain the fundamental elements of laboratory biosafety.
Clinical laboratory biosafety risk management program. Human papillomavirus laboratory manual first edition, 2first edition, 2009 oma ry m firstf who ivb10. The digenehc2 wash buffer contains sodium azide which is toxic and the denaturation reagent contains sodium hydroxide which is corrosive. Biosafety guidance for tb lab procedures technical consultation in sept.
Biosafety level designations are based on a composite of the design features, construction, containment. The general characteristics of the biosafety levels often referred to as bsl2 to bsl4 are summarized in table 1. Laboratory biosafety levels unc gillings school of. These pathogen safety data sheets, regulated under workplace hazardous materials information system whmis legislation, are produced for personnel working in the life sciences as quick safety reference material relating to infectious microorganisms. Guidelines for laboratory facility certification part ii. Cdc and the association of public health laboratories. Virtual manual can be used to easily generate a general laboratory safety manual. Laboratory biosafety manual world health organisation. Genital mucosal infection is persistent and multifocal and can be subclinical.
A spill of any quantity involving an agent infectious to humans, plants, or animals occurs in a public area. Are biosafetyrelated policies and procedures managed in a document control system to ensure that the most current documents are in use and available. Specimen collection is accomplished with a 30 second oral rinse and gargle with scopetm mouthwash. Each laboratory should have available the who laboratory biosafety manual. Are biosafety related policies and procedures managed in a document control system to ensure that the most current documents are in use and available. Biosafety, in medicine and health care settings, specifically refers to proper handling of organs or tissues from biological origin, or genetic therapy products, viruses with respect to the environment, to ensure the safety of health care workers, researchers, lab staff, patients, and the general public. Biosafety manual research and creative scholarship. Laboratory facilities are designated as basic biosafety level 1, basic biosafety level 2, containment biosafety level 3, and maximum containment biosafety level 4. Biosafety in microbiological and biomedical laboratories cdc.
Cohen, centers for disease control and prevention, atlanta, ga, usa. Follow procedure as outlined in the oid safety manual and chemical hygiene manual. Receive training in standard microbiological techniques. The levels of containment range from the lowest biosafety level 1 bsl1 to the highest at level 4 bsl4. The office of biosafety is requiring that human and other primate cells be handled using bsl2 practices. Biosafety records records that are retained as required by. The lab supervisor must ensure that lab personnel demonstrate proficiency in standard and special microbiological practices before working with bsl3 agents. An adequate biosafety manual will contain general biosafety information, as well as information specific to the biological agents and procedures used in the lab. Hpv, cervical cancer, cervical and uterine carcinoma, cervical dysplasia, genital warts condyloma acuminatum, venereal warts, anal and anogenital warts, the common wart verruca vulgaris, papilloma venereum, the common types are 6, 11, 16, 18, 31, 45, and 58. Biosafety level 3 bsl3 applies to the laboratory activities involving emerging viruses requiring containment level 3, typically those with a potential for respiratory transmission, often having a low infectious dose to cause serious or fatal illness.
Biosafety records records that are retained as required by regulatory and institutional policies for. Hpv laboratory network hpv labnet see annex in this document. Discuss the cdc recommended treatment regimens for genital warts. A human papillomavirus hpv, a member of the papillomavirus, is a doublestranded dna virus and produces cytopathic effect in epithelium.
Human papillomavirus laboratory manual first edition references 1. Laboratory manual for the examirriltion of human semcn and sperm cervical mucus interaction. The primary purpose of the biosafety manual is to provide an appropriate training and reference tool relative to biosafety for laboratory staff, as discussed in the ehs sop, biosafety training. Introduction this manual is intended to be a resource for information, guidelines, policies, and procedures that will enable and encourage those working in the laboratory environment to work safely and reduce or eliminate the potential for exposure to biological hazards. Appropriate ppe must be worn throughout all lab procedures. Who laboratory biosafety manual having served for global biosafety community hereinafter, who manual for more than 20 30 years, since it was first published in 1983, the laboratory biosafety manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. Clinical laboratory biosafety risk management program assessment checklist page 3of 21 question y n na comments risks and integrate safety practices into performing the tasks where appropriate. As needed, an adhoc committee may be formed to consider policy implications for the university of emerging technologies and processes that have a biosafety component. Risk groups are the result of a classification of microbiological agents based on their association with, and resulting severity of, disease in humans. Human papillomavirus laboratory manual first edition. Laboratory biosafety for handling emerging viruses.
Cdcaphl laboratory biosafety competencies for the bsl2, bsl. The virtual manual vm can be used to create the core of your biosafety manual. Biosafety level 2 bsl 2 is appropriate for handling moderate risk agents that cause human disease of. Biological laboratory safety training risk group classification nih guidelines for research involving recombinant dna molecules, 2011 who laboratory biosafety manual, 3rd edition risk group 1 agents that are not associated with disease in healthy adult humans.
Guidelines for laboratoryfacility certification part ii. The survey tool was released in april 2010 and was available for comment for 6 weeks. Who hpv laboratory network hpv labnet see annex in this document. National biosafety guidelines evolved from the efforts of the microbiological and. The new publication will combine the laboratory biosafety manual, 2nd ed. All laboratory work with samples is conducted in a certified biosafety cabinet. More than 30 to 40 types of hpv are typically transmitted through sexual contact and infect the anogenital region. The development of this third edition of the laboratory biosafety manual has been made possible through the contributions of the following, whose expertise is gratefully acknowledged. The bsls described in this manual should be differentiated from risk groups, as described in the nih guidelines and the world health organization laboratory biosafety manual. As a followup to the november 30 biosafety presentation, a rudimentary, workinprogress version of the laboratory biosafety manual has been posted on the research integrity and compliance website.
Bsl basic biosafety level bpv bovine papillomavirus c centigrade cin cervical intraepithelial neoplasia. The biosafety in microbiological and biomedical laboratories guidelines specify four levels of safety and security required for laboratory facilities in which such research will take place. For information regarding minors working in laboratory areas, please contact ehs. Laboratory biosafety and biosecurity risk assessment. Laboratory diagnosis of human papillomavirus virus infection. Key laboratory reagents are not standardized, and no gold standard exists for setting a. Appropriate personal protection equipment ppe is worn at all times during sample handling. All cervical cancers and 4% of all cancers are the result of hpv infections6,7. The biosafety manual is not a replacement or substitute for a general laboratory safety manual, which covers other occupational hazards in the laboratory. The mission of the who global hpv laboratory network labnet is to contribute to improving quality of laboratory services for effective surveillance and monitoring of hpv vaccination impact, through enhanced, stateoftheart laboratory support. The dose, or number of organisms required to cause disease can vary widely depending of the specific organism and the route of entry. The most important factor in the likelihood of a laboratoryacquired infection is the pathogenicity of the organism being handled. Sexually transmitted diseases treatment guidelines, 2010.
Invasive cancer is a rare outcome, many years generally decades after infection. Who diseasespecific laboratory management documents. Department of health and human services centers for disease control and prevention morbidity and mortality weekly report guidelines for biosafety. Cells immortalized with viral agents such as sv40, ebv adenovirus or hpv, as well as cells carrying viral genomic material also present potential hazards to laboratory personnel. The biosafety manual must be available and accessible. Laboratory biosafety manual world health organisation staff. From 2006 to 2010, on average, 33,160 hpvassociated cancers were. Guidelines for laboratory facility commissioning 8. For more than 20 years, since it was first published in 1983 the laboratory biosafety manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. Nov 24, 2009 a human papillomavirus hpv, a member of the papillomavirus, is a doublestranded dna virus and produces cytopathic effect in epithelium. The campus laboratory safety program is based on the premise that every member of the research community shares the responsibility for safety. Please note, the biosafety in microbiological and biomedical laboratories, fifth edition.
The evidencebased guidelines provided by the american dental. Geneva, world health organization, 2004 biosafety7. Specimen collection is performed by the nhanes staff in the mobile units and samples are shipped weekly to the oral hpv detection laboratory ohd, polaris innovation center, polaris, ohio. The most important factor in the likelihood of a laboratory acquired infection is the pathogenicity of the organism being handled. In 2012, the international hpv reference center was transferred to the karolinska institutet, under.
Cdcaphl laboratory biosafety competencies for the bsl2. Nih guidelines for research involving recombinant or synthetic nucleic acid molecules nih. Laboratory biosafety research center for pharmaceutical nanotechnology, university avenue, tabriz, iran url. The ifba has developed comprehensive biosafety programs across the full spectrum of biological threats including.
All specimen handling prelysis is to be performed in a biosafety cabinet. No or low individual and community risk a microorganism that is unlikely to cause. Afbsa supports the africa centre for integrated laboratory training course acilt held twice a year in johannesburg, south africa. Establishment of the first who international standards for hpv types 16 and 18 dna. Biosafety manual laboratory manual that gives practical guidance on overall laboratory operation to provide a safe environment for the use of biological materialsrecombinant dna.
Laboratory diagnosis of human papillomavirus virus. Two prophylactic human papillomavirus hpv vaccines are licensed and recommended for use in the united states u. Laboratory specific biosafety manual checklist each laboratory is required to have a labspecific biosafety manual and cannot be borrowed or copied from another lab. Laboratories are assigned a biosafety level numbered 1 through 4 based on. The bivalent hpv vaccine is licensed for 925 year old females, and the.
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