Introduction

Due to the ease of use and rapidness of point-of-care-testing (POCT), POCT equipment is widely used as a tool for making decisions related to the health, management or care needs of patients. Such decisions can include admission to hospital, evacuation to more appropriate care environments and directed patient management. There can also be either significant civil or legal implications, or both that arise from POCT such as cessation or termination of employment, family court rulings or revocation of bail or parole.

The availability of simple-to-use POCT equipment has led to continuous development in POCT, examples include testing for diabetes management, blood clotting factors, infectious disease markers, haemoglobin, white blood cell counts, pregnancy tests, cardiac markers, illicit drug use and performance enhancing chemical testing.

Whilst examinations of a patient’s body fluids, excreta and tissues have been performed traditionally in the controlled and regulated environment of a medical laboratory, globally, POCT is increasingly being performed outside of a traditional laboratory setting and by operators without medical laboratory support.

Circumstances where POCT testing can occur include, but are not limited to, hospitals, medical practices, pharmacies, ambulances, long-term care facilities, outreach clinics in remote and rural settings, in emergency and natural disasters and community settings such as law enforcement, workplace health and safety, sporting facilities, academia, the military and public areas such as shopping centres.

As POCT results can be used to make important decisions about patients, it is vital that the equipment works properly to yield the correct results and that the operators are trained and competent. This requires that a quality testing structure is provided by supervisors and made available to the operators.

Testing should be of benefit to the patient being tested. If the testing is not performed within a defined quality testing structure, then incorrect results can be obtained which can have a negative effect on the patient in terms of health outcomes or punitive action taken.

During the COVID-19 pandemic, the importance and context of POCT increased substantially. Testing was used to determine whether a patient could leave their residence, attend work or travel within and/or outside their country on a simple POCT, often self-conducted. The need for accurate POCT results in this context was never more obvious due to the profound effect an incorrect result could have on a patient.

This document has been written in easy to understand language. Its purpose is to provide supervisors and operators of POCT services guidance for assessing the appropriateness of proposed POCT, test and equipment selection, as well as skill requirements for technical performance and result interpretation that will ensure that the reliability, quality and interpretation of the results produced is of a quality appropriate to the intended use.

Manufacturers and their distributors should draw this document to the attention of purchasers of POCT equipment and encourage them to follow this document.

NOTE 1 Annexes A to E provide detailed information and add context that is not included in the main body of this document.

NOTE 2 Reference is made to medical laboratory professionals in 4.1, 6.2.2, 6.2.6.3, 6.2.9, 6.3.5, 6.4.2, 6.4.3.2, 6.5, 7.1, B.1.1 and D.1. Medical laboratory professionals with the required competence to offer advice can be found in laboratories adhering to international standards, e.g. ISO 15189.

PD ISO/TS 22583:2024

Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment

Current

Published:

31 Oct 2024