ISO/TS 7122:2024

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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This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

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 clinical laboratories.
The objectives of this document are to identify specialized use cases for real-time PCR testing systems
utilizing portable POCT devices in the POCT environment and to define datasets pertaining to result
information. By using the guidelines in this document, the portable real-time PCR systems can achieve not
only the interoperability with laboratory information systems, but also an easy integration across them
without making additional efforts.

v
Technical Specification ISO/TS 7122:2024(en)
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
1 Scope
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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
COVID-19
infectious disease caused by the new coronavirus SARS-CoV-2 discovered in 2019
[SOURCE: ISO/PAS 45005:2020, 3.6]

3.2
point-of-care testing
POCT
testing performed near or at the site of a patient, with the result leading to possible change in the care of
the patient
Note 1 to entry: Adapted from ISO 15189:2022, 3.22.
3.3
polymerase chain reaction
PCR
enzymatic procedure which allows in vitro amplification of DNA
[SOURCE: ISO 22174:2024, 3.1.17]
3.4
real-time PCR
method which combines PCR (3.3) and fluorescent probe detection of amplified product in the same
reaction vessel
[SOURCE: ISO 17822:2020, 3.40]
3.5
quality control
QC
system of maintaining standards in manufactured products by testing a sample of the output against the
specification
4 Use cases
4.1 General
Clause 4 describes the specialized use cases and interactions related to data flow between the portable PCR
devices used in the screening centre and laboratory information systems.
4.2 General test
4.2.1 Scenario
This subclause delineates a scenario and its sequence for transmitting test results from portable PCR devices
to the laboratory information system under the general testing case.
— A patient has COVID-19 symptoms and visits a nearby screening centre. A healthcare professional at the
screening centre collects specimens of the patient and conducts a real-time PCR test utilizing a portable
device on-site. The test result is positive. The real-time PCR system transmits results to the laboratory
information system. Subsequently, the patient promptly returns home and self-quarantines for two weeks.
4.2.2 Sequence
Figure 1 shows the sequence of general test, which includes the following steps:
1) Request test: request a real-time PCR test to the screening centre from internal/external professionals
and systems.
2) Confirm test: transmit/enter test information to a portable real-time PCR system and wait to perform
the test.
3) Analysing: perform the test to analyse the specimen in accordance with the requested test information.
4) Send results: send the test result to a laboratory information system.

Figure 1 — Sequence diagram of general test
4.3 Reconciliation of patient information
4.3.1 Scenario
In the context of rapid screening test utilizing portable real-time PCR devices, various exceptional situations
can occur in contrast to typical laboratory procedures. A representative use case can be reconciliation
procedure due to insufficient patient information.
— At the screening centre, to quickly perform numerous real-time PCR tests, the person in charge of tests
inputs an official identifier into each patient information without other demographic details. Once the
tests are completed, the screening centre sends the test results to the laboratory information system
without including patient demographics. In the laboratory information system, a data validator requests
the patient’s demographics from a hospital by using their official identifier and enters them into each
patient information.
— An unconscious patient is transported to a nearby hospital by ambulance. During transit, a paramedic
takes the patient's specimen. Upon the patient’s arrival at the hospital, an immediate real-time PCR
is conducted to swiftly screen for infectious diseases. During this procedure, the hospital assigns a
temporary identifier to the patient. The test outcome shows a negative result. The real-time PCR system
sends results to the laboratory information system. When the patient regains consciousness, their
identity is confirmed, and the temporary patient information in the test results is rectified and updated
to reflect the accurate details.
4.3.2 Sequence
Figure 2 shows the sequence of reconciliation of patient information, which includes the following steps:
1) Request test with insufficient patient information. Patient information can be empty or only identifiers
have been entered.
2) Issue a temporary patient identifie
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