| Name | Support | Language | Availability | Edition date | Price | ||
|---|---|---|---|---|---|---|---|
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PDF |
English |
Active |
9/1/2021 |
€193.00 |
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Details
This guideline provides a framework for facilitating consistency in reporting genotypes and bacterial, viral, and fungal strain typing and will assist laboratories that perform these studies and the professionals applying the results. Its purpose is to present not only the technologies used but also the criteria to be considered for design, verification, validation, and determination of clinical utility of such testing. These technologies are now used in many different contexts, including:Clinical care settingsPublic health investigations, particularly of emerging infectionsFood and pharmaceutical industriesEnvironmental analyses in the clinical settingRegulatory agenciesThis guideline is intended for manufacturers or laboratories that develop assays, laboratories that perform assays, clinicians who use the results to diagnose or manage patients, and agencies that regulate their use. This guideline:Is not intended for use by research laboratoriesIs not intended to provide manufacturing guidelinesDoes not discuss the development of standard reference materials for QC useIt is recommended that this guideline be used in conjunction with CLSI documents MM03, MM06, MM09, MM12, MM13, MM14, MM17, MM18, and MM22.
Additional Info
| Author | Clinical and Laboratory Standards Institute (CLSI) |
|---|---|
| Published by | CLSI |
| Document type | Standard |
| Theme | /subgroups/17908 |
| EAN ISBN | 9781684401277 |
| Number of pages | 178 |
| Keyword | CLSI MM24 |
