External Quality Assessment (EQA) for SARS-CoV-2 RNA Point-of-Care Testing in Primary Healthcare Services: Analytical Performance over Seven EQA Cycles.

In April 2020, the Aboriginal and Torres Strait Islander COVID-19 Point-of-Care (POC) Testing Program was initiated to improve access to rapid molecular-based SARS-CoV-2 detection in First Nations communities. At capacity, the program reached 105 health services across Australia. An external review estimated the program contributed to averting between 23,000 and 122,000 COVID-19 infections within 40 days of the first infection in a remote community, equating to cost savings of between AU$337 million and AU$1.8 billion. Essential to the quality management of this program, a customised External Quality Assessment (EQA) program was developed with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP). From July 2020 to May 2022, SARS-CoV-2 EQA participation ranged from 93 to 100%. Overall concordance of valid EQA results was high (98%), with improved performance following the first survey. These results are consistent with those reported by 12 Australian and 4 New Zealand laboratories for three SARS-CoV-2 RNA EQA surveys in March 2020, demonstrating that SARS-CoV-2 RNA POC testing in primary care settings can be performed to an equivalent laboratory analytical standard. More broadly, this study highlights the value of quality management practices in real-world testing environments and the benefits of ongoing EQA program participation.

Development of a pilot proficiency program for human papillomavirus DNA detection.

Human papillomavirus (HPV) DNA testing has become routine in many diagnostic laboratories, particularly with changes from cervical cytology to HPV DNA as primary screening as of 1 December 2017 in Australia. External quality assurance (EQA) is essential for assessment of laboratory performance once HPV testing is implemented. The aim of this study was to develop a pilot program to evaluate and determine stability of material that could be utilised in an ongoing external quality assurance program (EQAP). Two sample types were evaluated: cells in PreservCyt solution (ThinPrep) from stored clinical specimens and HPV-seeded swabs. Two panels sent 5 months apart were distributed to 18 Australian and two New Zealand laboratories (participants) for testing by Hybrid Capture 2 (HC2) or alternative molecular methods. Participants were given 1 month to test specimens. Eight ThinPrep specimens in Panel 1 were reported correctly by 73% (11/15) of HC2 participants and 40% (2/5) of participants performing alternative methods. Of eight dry swab specimens, 58% (23/40) and 78% (25/32) were correctly identified by HC2 and alternative methods, respectively. Panel 2 included four ThinPrep and two swab specimens. ThinPrep specimens were reported correctly by 100% (60/60) of participants utilising HC2 and 95% (19/20) utilising alternative methods. Dry swab specimens were reported correctly by 89% (25/28) of participants utilising HC2 and 100% (10/10) of participants utilising alternative methods. These results indicate that both specimen types are suitable for utilisation in an EQAP and outline some issues of EQAP for ongoing assessment of HPV molecular methods in diagnostic molecular laboratories.