scope:

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 settings

• Public health investigations, particularly of emerging infections

• Food and pharmaceutical industries

• Environmental analyses in the clinical setting

• Regulatory agencies

This 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 laboratories

• Is not intended to provide manufacturing guidelines

• Does not discuss the development of standard reference materials for QC use

It is recommended that this guideline be used in conjunction with CLSI documents MM03,¹ MM06,² MM09,³ MM12,⁴ MM13,⁵ MM14,⁶ MM17,⁷ MM18,⁸ and MM22.⁹