Standard Document
First Edition
Microbiology

CLSI M41

Viral Culture

This CLSI guideline provides essential guidance for viral culture and identification using commercially available cell cultures and reagents in clinical virology laboratories. It outlines critical factors for reliable viral culture, including cell culture selection, maintenance, quality control, specimen preparation, isolate identification, and result interpretation.

November 30, 2006
Lorraine M. Clarke, PhD

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Abstract

This document provides guidance for viral culture and identification procedures that are typically performed in the clinical virology laboratory setting using commercially available cell cultures and reagents. The nature of the cell culture system is one that is inherently variable and thus remains susceptible to numerous adverse conditions that can lead to unreliable results. Several critical elements that must be addressed in devising a viral culture procedure are identified. These include: cell culture selection, assessment and maintenance; cell culture verification and quality control; culture medium preparation and quality control; specimen collection and preparation; isolate identification; and result reporting and interpretation. The intended audience includes laboratories performing either limited or comprehensive viral cultures as well as those that are considering introduction of viral culture. Regardless of the viral diagnostic testing algorithm utilized by a laboratory, the basic principles of viral culture are universal.

Scope

This document focuses on viral culture and identification procedures that are typically performed in the clinical virology laboratory setting using commercially available monolayered cell cultures and reagents. Guidance for specimen collection, processing, and inoculation; cell culture selection, assessment, maintenance, and quality control; isolate detection and identification; and reporting and interpretation of test results, including information regarding potential limitations of the procedure, are outlined. The intended audience includes laboratories performing either limited or comprehensive viral culture procedures, as well as those that are considering introduction of viral culture.

Product Details
M41AE
1-56238-623-9
76
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

This document is available in electronic format only.

Authors
Lorraine M. Clarke, PhD
James B. Mahony, PhD
Holly Alexander, PhD
D. Kathleen Wright
Mary Beth Baker, MS, SV (ASCP), RM (AAM)
Martin R. Evans, PhD
Matthew J. Bankowski, PhD, D (ABMM)
Patricia C. Harris, MS, SM (AAM)
Carol Kirk
Robyn L. McGuire, PhD
Michael J. Loeffelholz, PhD, D (ABMM)
Ella M. Swierkosz, PhD
Abstract

This document provides guidance for viral culture and identification procedures that are typically performed in the clinical virology laboratory setting using commercially available cell cultures and reagents. The nature of the cell culture system is one that is inherently variable and thus remains susceptible to numerous adverse conditions that can lead to unreliable results. Several critical elements that must be addressed in devising a viral culture procedure are identified. These include: cell culture selection, assessment and maintenance; cell culture verification and quality control; culture medium preparation and quality control; specimen collection and preparation; isolate identification; and result reporting and interpretation. The intended audience includes laboratories performing either limited or comprehensive viral cultures as well as those that are considering introduction of viral culture. Regardless of the viral diagnostic testing algorithm utilized by a laboratory, the basic principles of viral culture are universal.

Scope

This document focuses on viral culture and identification procedures that are typically performed in the clinical virology laboratory setting using commercially available monolayered cell cultures and reagents. Guidance for specimen collection, processing, and inoculation; cell culture selection, assessment, maintenance, and quality control; isolate detection and identification; and reporting and interpretation of test results, including information regarding potential limitations of the procedure, are outlined. The intended audience includes laboratories performing either limited or comprehensive viral culture procedures, as well as those that are considering introduction of viral culture.

Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

This document is available in electronic format only.

Authors
Lorraine M. Clarke, PhD
James B. Mahony, PhD
Holly Alexander, PhD
D. Kathleen Wright
Mary Beth Baker, MS, SV (ASCP), RM (AAM)
Martin R. Evans, PhD
Matthew J. Bankowski, PhD, D (ABMM)
Patricia C. Harris, MS, SM (AAM)
Carol Kirk
Robyn L. McGuire, PhD
Michael J. Loeffelholz, PhD, D (ABMM)
Ella M. Swierkosz, PhD