ISO/DTS 7122

This draft is in the approval phase.

Abstract

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.

General information

Status
: Under development

Stage
: Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20]
Edition
: 1

Number of pages
: 16
Technical Committee :
ISO/TC 215

ICS :
35.240.80
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