Table 2.

Analytical sensitivity of the SARS-CoV-2 assay.

Sample material	SARS-CoV-2 RT-SIBA on PCR instrumenta				SARS-CoV-2 RT-SIBA on Egoo instrument
	Viral load of sample (cp/µl)	Copies to RT-SIBA reaction* (cp)	No. of Pos. (%)	Min. to pos (mean ± SD)	Viral load of sample (cp/µl)	Copies to RT-SIBA reaction¤ (cp)	No. of Pos. (%)	Min. to pos (mean ± SD)
Synthetic RNAb	1.0 × 105	2.5 × 105	6/6 (100)	8.5 ± 0.5	1.0 × 105	2.0 × 106	8/8 (100)	16.0 ± 1.5
	1.0 × 104	2.5 × 104	6/6 (100)	9.6 ± 0.1	1.0 × 104	2.0 × 105	6/6 (100)	16.7 ± 2.1
	1.0 × 103	2.5 × 103	6/6 (100)	10.3 ± 0.4	1.0 × 103	2.0 × 104	6/6 (100)	17.2 ± 1.7
	1.0 × 102	2.5 × 102	6/6 (100)	11.7 ± 0.5	1.0 × 102	2.0 × 103	6/6 (100)	19.8 ± 2.3
	1.0 × 101	2.5 × 101	6/6 (100)	14.3 ± 1.1	1.0 × 101	2.0 × 102	6/6 (100)	21.5 ± 3.3
	1.0 × 100	2.5 × 100	5/6 (83)	16.9 ± 0.9	1.0 × 100	2.0 × 101	7/7 (100)	25.6 ± 3.3
	1.0 × 10–1	2.5 × 10–1	na	na	1.0 × 10–1	2.0 × 100	1/8 (13)	22.9
	0	0	0/6	0	0	0	0/6	0
Virus culturec	1.2 × 103	2.9 × 103	64/64 (100)	12.6 ± 1.1	1.2 × 103	2.4 × 103	2/2 (100)	16.3 ± 0.7
	1.2 × 102	2.9 × 102	64/64 (100)	15.9 ± 1.9	1.2 × 102	2.4 × 102	1/1 (100)	21.88
	1.0 × 101	2.6 × 101	33/33 (100)	20.8 ± 3.0	1.2 × 101	1.0 × 102	2/2 (100)	21.4 ± 0.7
	9.3 × 100	2.3 × 101	32/33 (97)	19.9 ± 2.2	6 × 100	5.0 × 101	2/2 (100)	21.9 ± 1.4
	8.1 × 100	2.0 × 101	33/33 (100)	20.1 ± 1.8	1.3 × 100	2.5 × 101	19/20 (95)	21.8 ± 1.8
	6.3 × 100	1.6 × 101	31/33 (94)	21.9 ± 3.9	1 × 100	2.0 × 101	9/20 (45)	23.9 ± 2.9
	0	0	0/33	0	0	0	0/6	0

The bold highlights define the limit of detection.

na, not analyzed; no, number; Pos, positive; min, minutes; SD, standard deviation.

^aMX3005P.

^bTwistsyntetic SARS-COV-2 RNA ctr1.

^c2019-nCoV isolate (026V-03883) (EVAg).

*2.5 µl sample input to SARS-CoV-2 RT-SIBA reaction when the RT-SIBA reaction is performed in a PCR instrument, final volume 20 µl.

^¤20 µl sample input to SARS-CoV-2 Egoo capsule, when the RT-SIBA reaction is performed in the Egoo instrument, final volume 160 µl.