TABLE 1.

Performance of the SARS-CoV-2 variant assays

Characteristic	Strain or in vitro RNA	ΔH69/V70 assay		N501Y assay
		Wild-type probe	Mutant probe	Wild-type probe	Mutant probe
Analytical sensitivitya	H69/V70 deletion	2 copies/reaction	10 copies/reaction	NA	NA
	N501Y mutation	NAb	NA	3 copies/reaction	3 copies/reaction
% Analytical specificityc	NA	100	100	100	100
% Inter-assay reproducibility	Wild-type	0.57–0.85	NA	0.91–1.74	2.70–2.72
	B.1.1.7	NA	0.66–0.74	0.96–1.28	0.75–0.84
	B.1.351	0.39–0.67	NA	1.16–2.06	0.59–0.66
% Intra-assay reproducibility	Wild-type	0.31–1.16	NA	0.20–1.73	0.10–1.88
	B.1.1.7	NA	0.08–0.76	0.49–1.05	0.00–1.04
	B.1.351	0.14–0.48	NA	0.33–1.23	0.13–0.61
% Accuracy	Paneld	98.25 (95% CI 93.8–99.8)		100 (95% CI 96.8–100)

^aAnalytical sensitivity refers to 95% limit of detection based on probit analysis using in vitro transcribed RNA. Numbers for copies/reaction are rounded up.

^bNA, not applicable.

^cAnalytical specificity based on cross-reactivity to 34 commonly found respiratory pathogens.

^dAccuracy panel consisted of 10 B.1.1.7 positive samples, 99 wild-type positive samples, and 5 SARS-CoV-2 negative samples.