Abstract
Background: Using quality assurance testing, sound analytical performance of the SARS-CoV-2 RNA assay in the First Nations Molecular Point-of-Care Testing (POCT) Program has been previously reported. In June 2022, the Program transitioned to a multiplex respiratory assay, facilitating simultaneous detection of SARS-CoV-2, influenza (Flu) A and B, and respiratory syncytial virus (RSV) RNA on the same device. A customised quality assurance (QA) program for multiplex respiratory RNA testing by remote POCT operators was developed. This is the first report of POCT multiplex respiratory QA performance in this primary care setting.
Methods: Eight QA surveys, each comprising four samples, were manufactured by the Royal College of Pathologists of Australasia Quality Assurance Program and dispatched from mid-2022 to mid-2024. Each survey consisted of three inactivated positive SARS-CoV-2, Flu A, Flu B or RSV samples of varying viral loads, and a negative sample. The material was suspended in buffered saline with stabiliser, simulating a respiratory sample. QA testing was performed by trained POCT operators using the Xpert® Xpress SARS-CoV-2 or CoV-2/Flu/RSV assays (Cepheid, Sunnyvale). Operators submitted QA results for analytical performance evaluation and reporting.
Results: Eligible health service participation ranged from 73% (n=85, Survey 8) to 36% (n=90, Survey 14), with low participation reflecting workforce capacity in remote health services. Overall, mean positive QA concordance was high: SARS-CoV-2,100%, (8 surveys); Flu A, 98.6% (range 97.2-100%, 5 surveys); Flu B, 98.7% (range 97.3-100%, 2 surveys) and RSV, 98.1% (range 94.4-100%, 5 surveys). Mean concordance of negative QA samples was also high, 99.3% (range 97.3-100%, 6 surveys). Discordant QA results initiated corrective action/s and re-training as necessary.
Conclusion: Participation in a customised respiratory QA program demonstrated trained POCT operators perform molecular-based SARS-CoV-2/Flu/RSV RNA testing in primary care settings to a high analytical standard. Increased workforce capacity may support sustainable POCT quality compliance in these settings.
Methods: Eight QA surveys, each comprising four samples, were manufactured by the Royal College of Pathologists of Australasia Quality Assurance Program and dispatched from mid-2022 to mid-2024. Each survey consisted of three inactivated positive SARS-CoV-2, Flu A, Flu B or RSV samples of varying viral loads, and a negative sample. The material was suspended in buffered saline with stabiliser, simulating a respiratory sample. QA testing was performed by trained POCT operators using the Xpert® Xpress SARS-CoV-2 or CoV-2/Flu/RSV assays (Cepheid, Sunnyvale). Operators submitted QA results for analytical performance evaluation and reporting.
Results: Eligible health service participation ranged from 73% (n=85, Survey 8) to 36% (n=90, Survey 14), with low participation reflecting workforce capacity in remote health services. Overall, mean positive QA concordance was high: SARS-CoV-2,100%, (8 surveys); Flu A, 98.6% (range 97.2-100%, 5 surveys); Flu B, 98.7% (range 97.3-100%, 2 surveys) and RSV, 98.1% (range 94.4-100%, 5 surveys). Mean concordance of negative QA samples was also high, 99.3% (range 97.3-100%, 6 surveys). Discordant QA results initiated corrective action/s and re-training as necessary.
Conclusion: Participation in a customised respiratory QA program demonstrated trained POCT operators perform molecular-based SARS-CoV-2/Flu/RSV RNA testing in primary care settings to a high analytical standard. Increased workforce capacity may support sustainable POCT quality compliance in these settings.
| Original language | English |
|---|---|
| Number of pages | 2 |
| Publication status | Published - 21 Jun 2025 |
| Event | The 2nd Asia Pacific Conference on Point of Care Testing for Infectious Diseases: POC25 - Samyan Mitrtown Hall, Bangkok, Thailand Duration: 19 Jun 2025 → 21 Jun 2025 https://www.pocconference.com.au/ |
Conference
| Conference | The 2nd Asia Pacific Conference on Point of Care Testing for Infectious Diseases |
|---|---|
| Abbreviated title | POC25 |
| Country/Territory | Thailand |
| City | Bangkok |
| Period | 19/06/25 → 21/06/25 |
| Internet address |
Keywords
- point-of-care testing
- quality assurance
- analytical performance
- Respiratory virus
