CLSI eNews - 1 December 2006 (Plain Text Version)

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News
Executive Vice President's Message
CDC Cooperative Agreement: CLSI Advances Vision of Global Growth and Mission to Improve Health Care Worldwide
Essential New CLSI Antimicrobial Susceptibility Testing Updates Scheduled for Release in January 2007
Following the Rules: CLSI Auto10-A document provides a pathway to increased quality and efficiency
CLSI Announces New Corresponding and Associate Active Membership Categories Effective 1 January 2007
Press Releases
Standards Status
ALERT: Proposed-level Document Voting Period Reduced to 60 days
Vote and Deadlines
Recently Approved Documents
Events and Exhibits
Upcoming Events
CLSI Meetings Calendar
Participate in CLSI
Volunteer
New and Sustaining Members
Update Your Subscription

Press Releases

Evaluation of Quantitative Clinical Laboratory Measurement Procedures (EP10-A3); Optimizing Viral Culture Results (M41-A)

CLSI Publishes Guideline for Evaluation of Quantitative Clinical Laboratory Measurement Procedures
Wayne, Pennsylvania, USA—December 2006—Before starting a complete evaluation of a new measurement procedure, kit, or instrument for in vitro diagnostic use, it is often necessary to make a preliminary decision about its acceptability. This initial performance check is neither a rigorous characterization of long-term performance nor an evaluation of the many factors that can affect results produced by the device. Instead, it is a quick check to rule out major problems, and can serve as a starting point for accumulating data and experience that will enable the user to make a final decision.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published a document, Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition, which is intended to facilitate a limited, preliminary evaluation of the performance of a measurement procedure or device. Using the experimental design and data analysis procedure described, determination of whether a device has problems that require further evaluation or referral to the manufacturer can be done with a minimum expenditure of time and material.
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CLSI Publishes New Approved Guideline for Optimizing Viral Culture Results
Wayne, Pennsylvania, USA—December 2006—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. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published Viral Culture; Approved Guideline (M41-A), which provides recommendations for optimizing culture results. This document provides guidance for viral culture and identification procedures that are typically performed in the clinical virology laboratory setting using commercially available reagents and monolayered cell cultures.
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