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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