RNA Controls in Gene Expression Assays (MM16-A); Point-of-Care In Vitro Diagnostic Testing (POCT4-A2)

New CLSI Guideline Provides Protocols for the Use of RNA Controls in Gene Expression Assays
Wayne, Pennsylvania, USA—September 2006— Microarray and QRT-PCR technologies are emerging as vital components of genomic, evidence-based medicine. Standard controls are required to ensure reliability and quality from these assay platforms before microarray and QRT-PCR results are accepted for clinical applications. The ability to report reliable gene expression results of known quality is key to the successful employment of microarrays and QRT-PCR as tools in toxicogenomics, pharmacogenetics, pharmacogenomics, and as diagnostic devices in clinical medicine.

In response to this need, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published Use of External RNA Controls in Gene Expression Assays; Approved Guideline (MM16-A), which provides a set of agreed-upon protocols supporting the use of external RNA controls in microarray- and QRT-PCR-based gene expression experiments.
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New CLSI Point-of-Care In Vitro Testing Guideline Provides Information on How to Effectively Assess, Evaluate, and Implement POCT
Wayne, Pennsylvania, USA—September 2006— Advances in technology and the implementation of microtechniques and portable instruments have made it possible to expedite treatment decisions and move laboratory testing closer to the patient/client. Point-of-care testing (POCT), also known as bedside testing or near-patient testing, is intended to provide more rapid test results than can be achieved in central or satellite laboratory settings. This is important particularly in critical care areas, such as the intensive care unit, emergency rooms, burn units, emergency transport vehicles, and operating rooms, as well as in skilled nursing facilities and hospices.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new edition of the document, Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition (POCT4-A2), which provides users of in vitro diagnostic (IVD) devices outside the clinical laboratory with easy-to-follow information and suggestions for good laboratory practice and for producing reliable test results regardless of where the test is performed.
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