TABLE 2.

Results and clinical sensitivity and specificity of Hotgen based on COVID-19 RT-qPCR result in Brazil and the United Kingdom^a

Result confirmed by RT-qPCR, by location	Result of Hotgen
	No. with Ag-RDT result			Clinical sensitivity (95% CI), totalb	CT, % (95% CI), total			Clinical specificity (95% CI), totalc
	Positive	Negative	Total		≤20	≤25	≤33
BR, reference center				91.7% (81.9, 96.4), 60	97.1% (85.5, 99.9), 35	94.2% (84.4, 98.4), 52	91.7% (81.9, 96.4), 60	100.0% (98.5, 100.0), 249
Positive	55	5	60
Negative	0	249	249
Total	55	254	309
BR, community center				85.1% (72.3, 92.6), 47	100.0% (80.7, 100.0), 16	97.4% (86.5, 99.9), 38	87.0% (91.2, 100.0), 46	100.0% (95.9, 100.0), 137
Positive	40	7	47
Negative	0	90	90
Total	40	97	137
UK, community drive-through				85.1% (74.2, 92.6), 67	96.2% (80.3, 99.9), 26	83.6% (71.9, 91.8), 61	84.84% (73.9, 92.5), 66	100.0% (97.9, 100.0), 179
Positive	57	10	67
Negative	0	179	179
Total	57	189	246

^aRT-qPCR, real-time quantitative PCR; C_T, cycle threshold; CI, confidence interval; Ag-RDT, antigen-based rapid diagnostic test; BR, Brazil.

^bOverall clinical sensitivity was 88.2% (95% CI, 81.3, 93.3; total number, 174).

^cOverall clinical specificity was 100.0% (95% CI, 99.1, 100.0; total number, 518).