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ISO/TS 7122:2024

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
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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:

  • general test;
  • reconciliation of patient information;
  • cancel and rerun test;
  • 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.

SDO ISO: International Organization for Standardization
Document Number ISO/TS 7122
Publication Date Jan. 1, 2024
Language en - English
Page Count 24
Revision Level
Supercedes
Committee ISO/TC 215
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