ASTM_E_1286_-_00.pdf

Designation:E 1286 00Standard Guide forIdentification of Herpes Simplex Virus or Its DNA1This standard is issued under the fixed designation E 1286;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis guide covers the identification of herpes simplex virus(HSV)or its DNA and was developedby Subcommittee E48.02 on Characterization and Identification of Biological Systems.The objectiveis to describe laboratory characterization procedures that would be sufficient to verify that a biologicalpreparation believed to contain primarily HSV(or HSV DNA)for use in any step of a biotechnologyprocess actually does contain this virus(or its DNA).This guide assumes a basic knowledge of virology and molecular biology.1.Scope1.1 This guide covers laboratory characterization proce-dures sufficient to identify purified specimens of HSV types 1and 2(HSV-1 and HSV-2)or HSV-1 DNA and HSV-2 DNAused in biotechnology.For cases in which identification ofHSV DNA specimens is required,the characterization criteriaof 6.2 and 6.3 of this guide are sufficient.1.2 This guide does not cover the identification of HSV inHSV-infected host cells.To apply this guide to such a case,itwould first be necessary to isolate the virus from such samplesusing standard techniques of HSV purification.This guide doesnot cover characterization of segments of HSV DNA or ofvectors containing HSV DNA segments.1.3 This guide does not cover the specific methodology usedin the identification characterization.It does not address thequestion of degree of purity required for herpesvirus prepara-tions:this would vary depending on the particular biotechnol-ogy use of the virus.1.4 WarningLaboratory work involving herpes simplexviruses can be hazardous to personnel.Precaution:Biosafety2 level facilities are recommended(1).2Safety guidelines shallbe adhered to according to NCCLS M29T2 and other recom-mendations(1).1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:E 1873 Guide for Detection of Nucleic Sequences by thePolymerase Chain Reaction Technique32.2NCCLS Standards:M29T2 Protection of Laboratory Workers from InfectiousDisease Transmitted by Blood,Body Fluids,and TissueSecond Edition;Tentative Guideline43.Terminology3.1 Basic polymerase chain reaction(PCR)definitions ap-ply according to the general PCR Guide E 1873(Section 3).3.2 Definitions of Terms Specific to This Standard:3.2.1 capsomerea structural subunit of the outer proteinshell(capsid)of a virus consisting of protein monomers.3.2.2 envelopea layer of cell membrane-derived lipopro-tein that surrounds the protein coat(capsid)of some viruses.3.2.3 genome(of a virus)the genetic material consistingof nucleic acid(RNA or DNA).3.2.4 nucleocapsidthe outer protein coat or shell(capsid)of a virus plus its inner core of nucleic acid and proteins.3.2.5 plaquea round,clear area in a layer of host cellscaused by virus growth and resultant killing or lysis of thecells.3.2.6 restriction endonucleasea bacterial enzyme thatcuts double-stranded DNA at positions consisting of specificshort sequences of nucleotides.4.Significance and Use4.1 This guide is intended for use in a biotechnologylaboratory whenever the necessity arises for identifying abiological preparation believed to contain primarily HSV or its1This guide is under the jurisdiction ofASTM Committee E48 on Biotechnologyand is the direct responsibility of Subcommittee E48.02 on Characterization andIdentification of Biological Systems.Current edition approved September 10,2000.Published December 2000.Originally published as E 1286 89.Last previous edition E 1286 89(1994).2The boldface numbers in parentheses refer to a list of references at the end ofthis guide.3Annual Book of ASTM Standards,Vol 11.05.4Available from the National Committee for Clinical Laboratory Standards,940West Valley Road,Suite 1400,Wayne PA 19087.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.DNA.The characterization criteria used for the identificationshall be performed by an individual trained in molecularvirology.4.2 This guide is not meant to be used in a clinicallaboratory for the identification of HSV isolated from patientspecimens.5.Background Information About Herpes Simplex Virus5.1 Herpes simplex virus is a common human virus that cancause primary and recurrent infections of the skin and mucousmembranes(2-4).It has been classified by the InternationalCommittee on Taxonomy of Viruses as(a)Family:Herpesvirusgroup(Herpesviridae)and(b