ISO/DTS 7122

Health informatics — Guidelines for exchanging data generated by portable polymerase chain reaction (PCR) devices for point-of-care testing (POCT) between screening centre 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.