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

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.

Informatique de santé — Lignes directrices pour l'échange de données générées par des dispositifs portables de réaction de polymérisation en chaîne (PCR) pour les examens de biologie médicale délocalisée (EBMD) entre le centre de dépistage et le laboratoire clinique

General Information

• Status: Published
• Publication Date: 09-Dec-2024
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 10-Dec-2024
• Due Date: 10-Dec-2024
• Completion Date: 10-Dec-2024

Standards Content (Sample)

Technical
Specification
ISO/TS 7122
First edition
Health informatics — Guidelines
2024-12
for exchanging data generated by
portable polymerase chain reaction
(PCR) devices for point-of-care
testing (POCT) between screening
centre and clinical laboratory
Informatique de santé — Lignes directrices pour l'échange de
données générées par des dispositifs portables de réaction de
polymérisation en chaîne (PCR) pour les examens de biologie
médicale délocalisée (EBMD) entre le centre de dépistage et le
laboratoire clinique
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Use cases . 2
4.1 General .2
4.2 General test .2
4.2.1 Scenario .2
4.2.2 Sequence .2
4.3 Reconciliation of patient information .3
4.3.1 Scenario .3
4.3.2 Sequence .3
4.4 Cancel and rerun .5
4.4.1 Scenario .5
4.4.2 Sequence .5
4.5 On-site quality control (QC) .6
4.5.1 Scenario .6
4.5.2 Sequence .6
5 Dataset . 7
5.1 Data concept .7
5.2 Subject of Test .8
5.3 Order .9
5.4 Specimen .10
5.5 Result .11
6 Data guidelines for use cases .13
6.1 General test use case . 13
6.1.1 General . 13
6.1.2 Subject of Test . 13
6.1.3 Order . 13
6.1.4 Specimen . 13
6.1.5 Result . 13
6.2 Reconciliation of patient information use case .14
6.2.1 General .14
6.2.2 Subject of Test .14
6.3 Cancel and rerun use case .14
6.3.1 General .14
6.3.2 Order .14
6.3.3 Specimen .14
6.3.4 Result .14
6.4 On-site QC use case . 15
6.4.1 General . 15
6.4.2 Subject of Test . 15
6.4.3 Order . 15
6.4.4 Specimen . 15
Bibliography .16

iii
Foreword
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of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
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This document was prepared by Technical Committee ISO/TC 215, Health informatics.
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iv
Introduction
The COVID-19 pandemic has highlighted the need to establish robust social infrastructures capable of
conducting high-volume diagnostic tests and swiftly identifying confirmed cases at an early stage. However,
traditional clinical diagnostic testing typically involves prolonged result turnaround times, especially in
clinical laboratories handling hundreds of specimens daily.
Facing this challenge, innovative vendors have developed portable point-of-care testing (POCT) devices
capable of conducting real-time PCR testing specifically for diagnosing infectious diseases. These
advancements facilitate swift and accurate detection of infectious pathogens.
The problem with this method is there are no technical documents that explain how to operate portable
real-time PCR devices in the POCT environment and transmit their results into information systems. This
is because traditional laboratory-based specifications do not cover specific use cases, such as PCR devices
outside of clinica
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