CLSI ISO/TS 5798:2022
In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
This document is available in electronic format only.
Details
Date of Publication: April 1, 2022
Order Code PDF: CLSI ISOTS5798E
Order Code Print: print not available
Edition: First
Pages: 44
CLSI ISO/TS 5798:2022 Additional Details
Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.