ASTM E1286-00(2006)
(Guide)Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)
Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)
SIGNIFICANCE AND USE
This guide is intended for use in a biotechnology laboratory whenever the necessity arises for identifying a biological preparation believed to contain primarily HSV or its DNA. The characterization criteria used for the identification shall be performed by an individual trained in molecular virology.
This guide is not meant to be used in a clinical laboratory for the identification of HSV isolated from patient specimens.
SCOPE
1.1 This guide covers laboratory characterization procedures sufficient to identify purified specimens of HSV types 1 and 2 (HSV-1 and HSV-2) or HSV-1 DNA and HSV-2 DNA used in biotechnology. For cases in which identification of HSV DNA specimens is required, the characterization criteria of and of this guide are sufficient.
1.2 This guide does not cover the identification of HSV in HSV-infected host cells. To apply this guide to such a case, it would first be necessary to isolate the virus from such samples using standard techniques of HSV purification. This guide does not cover characterization of segments of HSV DNA or of vectors containing HSV DNA segments.
1.3 This guide does not cover the specific methodology used in the identification characterization. It does not address the question of degree of purity required for herpes virus preparations: this would vary depending on the particular biotechnology use of the virus.
1.4 Warning-Laboratory work involving herpes simplex viruses can be hazardous to personnel. Biosafety 2 level facilities are recommended (). Safety guidelines shall be adhered to according to NCCLS M29-T2 and other recommendations ().
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide covers laboratory characterization procedures sufficient to identify purified specimens of HSV types 1 and 2 (HSV-1 and HSV-2) or HSV-1 DNA and HSV-2 DNA used in biotechnology.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this guide was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:E1286 −00(Reapproved 2006)
Standard Guide for
Identification of Herpes Simplex Virus or Its DNA
This standard is issued under the fixed designation E1286; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This guide covers the identification of herpes simplex virus (HSV) or its DNAand was developed
by Subcommittee E48.02 on Characterization and Identification of Biological Systems.The objective
istodescribelaboratorycharacterizationproceduresthatwouldbesufficienttoverifythatabiological
preparation believed to contain primarily HSV(or HSVDNA) for use in any step of a biotechnology
process actually does contain this virus (or its DNA).
This guide assumes a basic knowledge of virology and molecular biology.
1. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This guide covers laboratory characterization proce-
bility of regulatory limitations prior to use.
dures sufficient to identify purified specimens of HSV types 1
and 2 (HSV-1 and HSV-2) or HSV-1 DNA and HSV-2 DNA
2. Referenced Documents
used in biotechnology. For cases in which identification of
2.1 ASTM Standards:
HSV DNA specimens is required, the characterization criteria
E1873Guide for Detection of Nucleic Acid Sequences by
of 6.2 and 6.3 of this guide are sufficient.
the Polymerase Chain Reaction Technique
1.2 This guide does not cover the identification of HSV in
2.2 NCCLS Standards:
HSV-infected host cells. To apply this guide to such a case, it
M29–T2Protection of Laboratory Workers from Infectious
would first be necessary to isolate the virus from such samples
DiseaseTransmittedbyBlood,BodyFluids,andTissue—
usingstandardtechniquesofHSVpurification.Thisguidedoes
Second Edition; Tentative Guideline
not cover characterization of segments of HSV DNA or of
3. Terminology
vectors containing HSV DNA segments.
3.1 Basic polymerase chain reaction (PCR) definitions ap-
1.3 Thisguidedoesnotcoverthespecificmethodologyused
ply according to the general PCR Guide E1873 (Section 3).
in the identification characterization. It does not address the
question of degree of purity required for herpesvirus prepara-
3.2 Definitions of Terms Specific to This Standard:
tions: this would vary depending on the particular biotechnol-
3.2.1 capsomere—a structural subunit of the outer protein
ogy use of the virus.
shell (capsid) of a virus consisting of protein monomers.
1.4 Warning—Laboratory work involving herpes simplex
3.2.2 envelope—a layer of cell membrane-derived lipopro-
viruses can be hazardous to personnel. Biosafety 2 level
tein that surrounds the protein coat (capsid) of some viruses.
facilities are recommended (1). Safety guidelines shall be
3.2.3 genome (of a virus)—the genetic material consisting
adhered to according to NCCLS M29–T2 and other recom-
of nucleic acid (RNA or DNA).
mendations (1).
3.2.4 nucleocapsid—the outer protein coat or shell (capsid)
1.5 This standard does not purport to address all of the
of a virus plus its inner core of nucleic acid and proteins.
safety concerns, if any, associated with its use. It is the
3.2.5 plaque—a round, clear area in a layer of host cells
caused by virus growth and resultant killing or lysis of the
cells.
This guide is under the jurisdiction ofASTM Committee E55 on Manufacture
ofPharmaceuticalProductsandisthedirectresponsibilityofSubcommitteeE55.04
on General Biopharmaceutical Standards. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 1, 2006. Published December 2006. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1989. Last previous edition approved in 2000 as E1286–00. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E1286-00R06. the ASTM website.
The boldface numbers in parentheses refer to a list of references at the end of Available from the National Committee for Clinical Laboratory Standards, 940
this guide. West Valley Road, Suite 1400, Wayne PA 19087.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1286−00 (2006)
3.2.6 restriction endonuclease—abacterialenzymethatcuts exists in four isomeric forms. HSV-1 DNAshares about 50%
double-stranded DNA at positions consisting of specific short of its sequences with HSV-2. Isolated HSVDNAis infectious.
sequences of nucleotides.
5.5 There are many uses of HSV or its DNA in basic and
applied biotechnology. Examples of applied uses include the
4. Significance and Use
preparation of DNA probes and monoclonal antibodies for in
vitro diagnostic testing and utilization of the virus in in vitro
4.1 This guide is intended for use in a biotechnology
testing of antiviral substances.
laboratory whenever the necessity arises for identifying a
biologicalpreparationbelievedtocontainprimarilyHSVorits
6. Characterization Criteria for Identification
DNA. The characterization criteria used for the identification
6.1 Immunological Evidence—Immunological evidence
shall be performed by an individual trained in molecular
shall be provided such as demonstrating HSV envelope glyco-
virology.
protein antigen in viral-infected host cells by immunofluores-
4.2 This guide is not meant to be used in a clinical
cent(IF)orimmunoperoxidasestaining,orWesternblottingof
laboratory for the identification of HSV isolated from patient
sodium dodecyl sulfate polyacrylamide gel electrophoresis
specimens.
(SDSPAGE)gels(forexample,seeRefs (3, 5 and 6)).Enzyme
immunoassay(EIAorELISA)orradioimmunoassay(RIA)can
5. Background Information About Herpes Simplex Virus
also be used to demonstrate the presence of HSV envelope
glycoprotein (3, 5 and 6). HSV-1 can be differentiated from
5.1 Herpessimplexvirusisacommonhumanvirusthatcan
HSV-2, and different strains of the viruses can be distin-
cause primary and recurrent infections of the skin and mucous
guished, by the use of appropriate monoclonal antibodies for
membranes (2-4). It has been classified by the International
immunofluorescence or EIA. Any one of a number of pub-
CommitteeonTaxonomyofVirusesas(a)Family:Herpesvirus
lished protocols can be used. It should be pointed out that,
group (Herpesviridae) and (b) Subfamily: Herpes simplex
although different species of herpes viruses have distinct
virus group (Alphaherpesvirinae ) (2). There are two main
envelope glycoproteins, there are some shared antigenic deter-
immunologic variants of HSV, types 1 and 2 (HSV-1 and
minants (3).
HSV-2). They are officially known as human (alpha) herpes-
virus 1 and human (alpha) herpesvirus 2 (2). HSV-1 has been
6.2 DNA Gel Electrophoresis—Gel electrophoresis patterns
isolated primarily from the oral cavity, eye, and skin vesicles
of restriction endonuclease fragments of isolated HSV
...
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