Table 2.

Risk identification and mitigation.

Outcome	Risk	Risk if there is no PoC test	Risk if PoC test is implemented	Risk Difference	Relevant Risk Mitigation Strategy
False negative COVID-19	False negative is not able to be confirmed by the public health lab	100% of COVID cases will continue to interact with the community actively spreading the infection as a test would not have occurred.	Up to 30% of cases tested could be a false negative	Risk is lower by completing PoC testing	Patient should be isolated and retested next day if there are clinical concerns for a false negative
	False negative that can be corrected by the public health laboratory	Could not occur as the public laboratory does not need to confirm its own result	The chances of this occurring are unknown but expected to be small with units listed in Table 1.	This should be small given the similar automated tests are used in the public hospital setting	Consider sending a proportion of negative samples to a public health laboratory for confirmation.
False positive COVID-19	If a positive is identified and the public health lab is unable to confirm this	Could not occur as no confirmation test is done	Unnecessary diagnosis, further investigation and isolation Unnecessary intensity of clinical monitoring Stigma attached to having COVID-19 Initiating therapeutics assuming positive result	False positive rates are expected to be small Treatment is currently only symptomatic treatment and isolation, no pharmacological risk currently	Informed consent within the team prior to doing test Careful maintenance and cleaning of working space to limit contamination May require additional support from team doctor/mental health professional
	False positive that can be corrected by the public health laboratory	Could not occur	Consider probability that a low positive sample degrades prior to reference laboratory testing Confusion and distrust in PoC test	Discordant PoC to public health laboratory results could occur. The chances of this occurring are unknown	Reference laboratory testing is a risk mitigation strategy Review for sources of contamination in testing workflow Complete additional negative quality controls Option of re-testing same individuals 24 hours later