Draft Details

Number:Draft ISO DTS 5798
Committee:ISO TC 212/JWG 6
Committee name:Joint ISO/TC 212 - ISO/TC 276 WG: Quality practice for detection of SARS-CoV-2
Review published:15 Nov 2021
Review end date:20 Dec 2021
Contact email:nepadmin(at)nsai.ie
Draft Scope:

This document provides 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.

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