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Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this guide was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

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.

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.