ISO/DTS 24883

In vitro diagnostic medical devices — General Guidance for manufacturers of lateral flow immunoassay (LFIA) for rapid diagnostic testing (RDT)

Апстракт

This document provides the general principles and guideline for the rapid diagnostic testing (RDT) of LFIA used for the In vitro diagnostics as follows:
— Design and development of LFIA
— General guideline for test performance of LFIA
— Recommendations for the use of LFIA

This document is specific to the RDT of LFIA, which employ the gold nanoparticle as the conjugate and read the signal either with naked eye or through reader devices. This document does not apply to other types of LFIA such as automatic devices and microfluidic chips.

This document should be expected to be helpful to increase efficiency and reduce trials and errors when manufacturing LFIA RDT products to the industries and/or manufacturers.