The management of and control of infections and spread of SARS-CoV-2 requires effective in-vitro diagnostics.
The use of accurate testing methods is a key tool to ascertain the level of infection in populations. Acceptable design, validation and verification of quality SARS-CoV-2 diagnostics based on nucleic acid is required to ensure effective results are achieved.
As the number of test methods and kits grow, setting out comprehensive quality evaluation methods for development and routine testing will ensure the quality and accuracy of the results.
A new draft Technical Specification or DTS is being developed setting out quality practice for SARS-CoV-2 detection:
ISO DTS 5798 – Quality Practice for detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods.
ISO DTS 5798 provides recommendations for the design development, verification, validation and implementation of analytical tests for detection of SARS-CoV-2 using nucleic acid amplification. This standard applies to medical laboratories carrying out such tests and to in-vitro diagnostic developers and manufacturers as well as organizations supporting SARS-CoV-2 research.
This draft standard is currently available on the NSAI draft standard portal – Your Standard Your Say – below
The deadline for reviewing and submitting comments on this draft is December 20th 2021.