ISO/CD TS 7122

Abstract

This document identifies use cases related to the exchange of information between new small-sized point of care testing devices that enable real time PCR testing for diagnosis of infectious diseases, and clinical laboratories. This document is applicable to use cases of small-sized real time PCR devices, including those that: a) general test; b) lack of patient information; c) cancel and rerun test; d) on-site Quality Control (QC) process. This document also provides guidelines on how to represent and exchange the result of real time PCR testing devices in a POCT environment applicable to the use cases described above. This document is not intended to provide guidelines relating to traditional diagnostic testing results within a clinical laboratory.