CLSI Awarded Contract to Improve Laboratory Practices in Mali
Evaluation of Qualitative Test Performance (EP12-A2)
Blood Specimens for Coagulation Assays (H21-A5)
Protocol for the Evaluation, Validation, and Implementation of Coagulometers (H57-A)
Quality Control for Commercial Microbial Identification Systems (M50-P)

CLSI Awarded Contract to Improve Laboratory Practices in Mali
Wayne, Pennsylvania, USA—February 2008—Global standards-development organization Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has been awarded a contract from the National Institutes of Health (NIH)/National Institute for Allergies and Infectious Diseases (NIAID) for organizing, managing, and implementing quality management system training and technical support activities for the Malarial Research Training Center (MRTC) Clinical Laboratory in Bamako, Mali.
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CLSI Publishes Guideline for Evaluation of Qualitative Test Performance
Wayne, Pennsylvania, USA—February 2008—Qualitative diagnostic tests have been used since the early days of laboratory medicine for the screening, diagnosis, and management of a variety of diseases. Method evaluation procedures for such tests are diverse, with each laboratory specialty often emphasizing different issues in both the experimental design and in the data analysis and interpretation of such studies.

Clinical and Laboratory Standards Institute (CLSI) recently published an updated document, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition (EP12-A2), to provide guidance for performing uniform, well-defined studies that can be used to adequately evaluate and describe performance characteristics of qualitative tests.
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CLSI Publishes Guideline for the Collection, Transport, and Processing of Blood Specimens for Coagulation Assays
Wayne, Pennsylvania, USA—February 2008—The reliability and accuracy of coagulation test results depend upon a variety of variables, including anticoagulant volume and concentration, type of tube additive, duration and temperature of specimen storage, and surface of containers used for specimen collection and storage.

Because of the many variables that can affect coagulation test results, Clinical and Laboratory Standards Institute (CLSI) recently published an updated guideline, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition (H21-A5), which provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests.
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CLSI Publishes Protocol for the Evaluation, Validation, and Implementation of Coagulometers
Wayne, Pennsylvania, USA—February 2008—Coagulometers are used in clinical laboratories for the common screening tests including prothrombin time, activated partial thromboplastin time, thrombin clotting time, and Clauss fibrinogen assay. In addition, most coagulometers also perform chromogenic and immunoturbidometric assays. Some analyzers may also have the capability to perform chemiluminescent assays. With newer trends in hemostasis testing and tailored reagent/instrument manufacturing, there is a need for a more holistic outlook to instrument evaluation prior to use for testing patient samples.

In response to this need, Clinical and Laboratory Standards Institute (CLSI) recently published a new document, Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline (H57-A), which specifies recommendations on how to plan and execute the selection, evaluation, validation, and implementation of a laboratory coagulometer. It includes assessment of safety, carryover, precision, bias, linearity, and comparability for coagulometers that perform clotting, chromogenic, and/or immunoturbidometric and/or chemiluminescent testing. Finally, guidance is given on implementation, including training, education, and interfacing.
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New CLSI Guideline Addresses Quality Control for Commercial Microbial Identification Systems
Wayne, Pennsylvania, USA—February 2008—Microbial identification systems (MISs) are test systems that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeast-like algae grown from culture. MISs have become increasingly complex, which has resulted in the need for a greater number of quality control (QC) organisms to check positive and negative reactivity for all components. In 2005, the American Society for Microbiology (ASM), at the suggestion of the Clinical Laboratory Improvement Advisory Committee (CLIAC), conducted a microbiology laboratory survey to determine the QC failure rates of commercial MISs in a random selection of laboratories that perform bacterial and fungal identification from culture. The data showed a failure rate of less than 0.1% for all commercial MISs surveyed.

As a result, Clinical and Laboratory Standards Institute (CLSI) used its consensus process to develop the recently published document, Quality Control for Commercial Microbial Identification Systems; Proposed Guideline (M50-P). This includes guidelines that may be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included in the Clinical Laboratory Improvement Amendments of 1988 regulations. It is anticipated that these guidelines will receive widespread use in the United States, and could reduce unnecessary costs and other resources spent on excessive QC testing.
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