Abstract
Background:
The Aboriginal and Torres Strait Islander COVID-19 Point-of-Care Testing (POCT) Program was established by the Australian Government in April 2020 to improve access to rapid, molecular-based COVID-19 detection in regional/remote Indigenous communities. The program was implemented in 105 health services utilising SARS-CoV-2 RNA testing on the Cepheid GeneXpert®. A bespoke external quality assurance (EQA) program was developed collaboratively with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) to comply with National Pathology Accreditation Advisory Council requirements for POCT in Australia. This is the first report of SARS-CoV-2 POCT EQA performance in primary care settings.
Methods: Each EQA survey consisted of 2 samples; a SARS-CoV-2 positive (of variable viral loads) inactivated by gamma irradiation and a negative. The material was suspended in 800µL of buffered saline to simulate a respiratory sample. Different SARS-CoV-2 variants were included in EQA samples as they became of concern. The samples were laboratory tested prior to dispatch. EQA samples were tested at health services by trained and competent POCT operators. Results were submitted via manual result forms or online entry for analysis by the RCPAQAP. Generic and individual site RCPAQAP reports were generated and issued for overall performance and site performance review.
Results: Seven EQA surveys were completed from mid-2020 to mid-2022. Eligible health service EQA participation ranged from 91.0% (n=81, survey 6) to 98.9% (n=86, survey 5). For positive EQA samples, mean concordance was 98.3% (range 91.9-100%); while for negative samples, the mean concordance was 98.4% (range 94.5-100%). Concordance of each EQA survey improved from Survey 1 (93.2%) to Survey 2 (98.8%) and remained consistent across Surveys 3 to 7 (99%, range 98.8-100%).
Conclusion:
This customised EQA program demonstrated that trained and competent, non-laboratory POCT operators can perform SARS-CoV-2 RNA testing in primary care settings to a high analytical standard.
The Aboriginal and Torres Strait Islander COVID-19 Point-of-Care Testing (POCT) Program was established by the Australian Government in April 2020 to improve access to rapid, molecular-based COVID-19 detection in regional/remote Indigenous communities. The program was implemented in 105 health services utilising SARS-CoV-2 RNA testing on the Cepheid GeneXpert®. A bespoke external quality assurance (EQA) program was developed collaboratively with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) to comply with National Pathology Accreditation Advisory Council requirements for POCT in Australia. This is the first report of SARS-CoV-2 POCT EQA performance in primary care settings.
Methods: Each EQA survey consisted of 2 samples; a SARS-CoV-2 positive (of variable viral loads) inactivated by gamma irradiation and a negative. The material was suspended in 800µL of buffered saline to simulate a respiratory sample. Different SARS-CoV-2 variants were included in EQA samples as they became of concern. The samples were laboratory tested prior to dispatch. EQA samples were tested at health services by trained and competent POCT operators. Results were submitted via manual result forms or online entry for analysis by the RCPAQAP. Generic and individual site RCPAQAP reports were generated and issued for overall performance and site performance review.
Results: Seven EQA surveys were completed from mid-2020 to mid-2022. Eligible health service EQA participation ranged from 91.0% (n=81, survey 6) to 98.9% (n=86, survey 5). For positive EQA samples, mean concordance was 98.3% (range 91.9-100%); while for negative samples, the mean concordance was 98.4% (range 94.5-100%). Concordance of each EQA survey improved from Survey 1 (93.2%) to Survey 2 (98.8%) and remained consistent across Surveys 3 to 7 (99%, range 98.8-100%).
Conclusion:
This customised EQA program demonstrated that trained and competent, non-laboratory POCT operators can perform SARS-CoV-2 RNA testing in primary care settings to a high analytical standard.
| Original language | English |
|---|---|
| Number of pages | 1 |
| Publication status | Published - 3 Mar 2023 |
| Event | Australasian Conference on Point of Care Testing for Infectious Diseases - Sheraton Grand Sydney Hyde Park, Sydney, Australia Duration: 14 Mar 2023 → 15 Mar 2023 Conference number: 1st https://www.kirby.unsw.edu.au/events/poc23-1st-australasian-conference-point-care-testing-infectious-disease (Conference link) |
Conference
| Conference | Australasian Conference on Point of Care Testing for Infectious Diseases |
|---|---|
| Abbreviated title | POC23 |
| Country/Territory | Australia |
| City | Sydney |
| Period | 14/03/23 → 15/03/23 |
| Other | To accelerate access to new point-of-care technology, we need research in all these areas to provide the most effective implementation pathways. To respond to this evolving challenge, ASHM and the RAPID Point of Care Research Consortium for infectious disease in the Asia Pacific made the decision to run this two-day conference. The conference will collaborate with leading scientists, clinicians, and other stakeholders to develop a program on the ever-evolving landscape of point-of-care testing for infectious diseases and provide time to discuss challenges and solutions to scaling up point-of-care testing in this setting. |
| Internet address |
Keywords
- SARS-Cov 2
- RNA
- quality assurance
- point of care
