ISO/AWI TS 7122

Health Informatics — Guidelines for exchanging data generated by POCT (Point of Care Testing) devices between screening center and clinical laboratory

Scope

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.