A-361 Implementation of a Fit-for-purpose Point of Care Quality Assurance Program
Authors: Dimech W J , Cabuang L , Vincini G 
Published: September 2023

Abstract

Background
All individuals should have equitable access to accurate and timely testing for infectious diseases. Point of care testing (PoCT) has been developed to support populations having limited access to laboratory-based testing. Unlike laboratory-based testing, PoCT is often performed by non-laboratory staff and outside the jurisdiction of regulatory frameworks. Under these conditions, quality assurance (QA) of PoCT is often lacking; inaccurate testing can go undetected, leading to poor patient outcomes. A fit-for-purpose QA program was developed to monitor the quality of PoCT for infectious disease testing, particularly in low-middle income countries and in testing outside the laboratory regulatory environment.

Methods
In collaboration with the World Health Organization (WHO), the National Serology Reference Laboratory (NRL) reviewed the barriers to participation in QA programs experienced by PoCT sites. Using this information, NRL developed a QA model specifically designed for PoCT for infectious disease. In collaboration with Foundation for Innovative and New Diagnostics (FIND, Geneva, Switzerland), Kirby Institute (Sydney, Australia) and Flinders University (Adelaide, Australia), NRL implemented the PoCT QA model across Africa, Asia, and remote regional Australia. The model consists of competency panels (CP - one positive and one negative sample) and external quality assessment (EQA) panels. The EQA panels contain five samples. Whereas the test site knows the reactivity of the CP samples, the EQA samples are tested blinded. Both panels use inactivated samples that are stable at ambient temperature. The model uses streamlined logistics channels, with data collection and analysis using smartphone technology and QR codes. NRL designed a method for randomizing the identity of EQA sample vials so test sites can test QA panels ad hoc, and not be limited to specific test event dates. A range of support material such as pictorial instructions for use, virtual training events and on-line videos were produced to support test sites.

Results
More than 100 test sites from 14 countries have participated in the NRL PoCT QA programs. The model is designed so data is collected by test sites scanning QR codes and entering results directly into a data entry screen. The NRL PoCT QA program removed barriers to participation by offering sample types that are inactivated and stable at ambient temperature for extended periods of time, removing the need for dry ice shipping. The program is cost effective making it accessible to low- and middle-income countries. Data is collected using novel smartphone technology, facilitating results to be entered into a central database for immediate analysis. Testing of the QA samples can be done at any time, avoiding set test events.

Conclusion
Implementation of a fit-for-purpose PoCT QA for infectious disease testing removes the barriers to participation and facilitates the monitoring of testing over time. Any deficiencies in testing can be detected and addressed rapidly, ensuring that accurate test results are reported, and the population protected.