Table 2.

Pre-analytical, analytical and post-analytical issues identified in this study to address in implementing SARS-CoV-2 antigen testing.

Pre-analytical issues	Pre-analytical solutions	Analytical issues	Analytical solutions	Post-analytical issues	Post-analytical solutions
Purpose	Clearly define the purpose of testing, e.g., screening or diagnostic testing	Quality control	Perform negative and positive controls on new batches	Waste	Provide biohazardous waste disposal and ensure disposable antigen test devices are discarded appropriately
Target group	Clearly define the appropriate population, e.g., based on symptoms or epidemiological risk factors	Test validation	Clearly identify the reference standard and the limitations of the reference standard	Confirmation	Define pathways to confirm positive results with RT-PCR, especially low-prevalence settings, when a positive result has higher likelihood of being false-positive
Resourcing	Identify testing location, adequate space for registration, swabbing, donning/doffing and ensure resourcing of PPE/equipment	Impact: Disease prevalence	Understand the impact of the prevalence of disease on positive and negative predictive value of the test	Exclusion	Define pathways to perform RT-PCR if result is negative and clinical/ epidemiological suspicion remains high, especially in high-prevalence settings
Specimen collection	Ensure staff are available and trained in PPE and infection control in addition to training staff in the use of novel diagnostic tests	Impact: Assay characteristics	Understand the sensitivity and specificity of the antigen assay in the target group of interest	Reporting	Communicate results in a timely and accurate manner, e.g., text message / telephone call if no cellular device
Leadership	Ensure adequate clinical supervision is available to identify issues, escalate and communicate with key stakeholders	Impact: Clinical characteristics	Understand the performance on the test based on the clinical characteristics of the patient, e.g., duration of symptoms	Quality assurance	Consider role of external quality assurance program and incorporate into quality management system
Data management	Ensure data is captured, accurate, confidential and stored securely (e.g., photograph result of lateral flow Ag assay)	Impact: Public health	Consider public health implications in the context of above, e.g., false negative result in aged care worker
Specimen handling	Handle all specimens using appropriate PPE and consider testing as close to patient as feasible to reduce transport needs