ISO/TS 7122:2024 PDF

This document identifies specialized use cases related to the information exchange between clinical laboratories and portable polymerase chain reaction (PCR) devices designed for real-time testing to diagnose infectious diseases. This document introduces the portable PCR devices for point-of-care testing (POCT). Characteristic and differentiated use cases of these devices are listed separately from those that occur with portable POCT devices in existing clinical laboratory. This document is applicable, but not limited, to the following use cases of portable PCR devices for POCT: a) general test; b) reconciliation 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 results from portable 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 and does not cover cybersecurity aspect.