Table 3.

The clinical sensitivity and specificity of the SARS-CoV-2 Egoo Health system compared to different RT-PCR platforms (n = 1154).

NA and RT-PCR platform	Material	CT	P	N	TP	TN	FP	FN	SE (%)	95% Cl (%)	SP (%)	95% Cl (%)
Direct lysis and RT-PCRa	OP in PBS	≤ 45	133	98	127	95	3	6	95.5	90.4–98.3	96.9–100*	91.3–99.4
		≤ 38	133	98	127	95	3	6	95.5	90.4–98.3
		≤ 37	131	98	127	95	3	4	96.9	92.4–99.3
		≤ 36	130	98	127	95	3	3	97.7	93.4–99.5
		≤ 35	129	98	127	95	3	2	98.5	94.5–99.8
Roche Flow/MGI-BGI RT-PCRb	OP in UTM	≤ 45	525	175	482	169	6	43	91.8	89.1–94.0	96.6–100.0*	92.7–98.7
		≤ 38	504	175	473	169	6	31	93.9	91.4–95.8
		≤ 37	494	175	468	169	6	26	94.7	92.4–96.5
		≤ 36	482	175	462	169	6	20	95.9	93.7–97.5
		≤ 35	466	175	450	169	6	16	96.6	94.5–98.0
Cobas LIAT Systemc	OP in UTM	N/A	115	109	100	107	2	15	87.0	79.4–92.5	98.2	93.5–99.8

NA, nucleic acids; P, positive; N, negative; TP, true positive; TN, true negative; FP, false positive; FN, false negative; SE, sensitivity; SP, specificity; CI, confidence interval; OP, oropharyngeal swab; PBS, phosphate-buffered saline, UTM, universal transport medium.

^aDiagnosed with direct lysis using SIBA lysis/reaction buffer and the RT-PCR for the E-gene³³.

^bDiagnose with the SARS-CoV-2 Roche Flow/MGI-BGI RT-PCR.

^cDiagnosed with the Cobas SARS-CoV-2 & Influenza A/B NAAT test.

*Based on evaluation of the curves and not the Clinical app.