TABLE 4.

Identification of factors contributing to assay performance, in-house assay^a

		In-House developed SARS-CoV-2 serological assay specificity and sensitivity
		Specificity (%)		Sensitivity (%)						Cohen's kappa agreement
Assay ID	Antibody	N	Overall	N	Infected	N	Vaccinated	N	Overall (%)	Overall
11	Pan Ig	180	75.0	246	100.0	276	100.0	522	100.0	0.82
12	Pan Ig	180	72.8	246	99.2	276	100.0	522	99.6	0.79
13	Pan Ig	180	81.1	246	99.6	276	100.0	522	99.8	0.86
14	Pan Ig	180	39.4	246	95.5	276	89.5	522	92.3	0.36
15	Pan Ig	180	79.4	246	97.6	–	–	246	97.6	0.79
16	Pan Ig	180	90.6	246	99.2	276	98.6	522	98.9	0.91
17	Pan Ig	180	79.4	246	81.3	276	86.2	522	83.9	0.59
18	IgG	180	78.3	246	100.0	276	100.0	522	100.0	0.84
19	IgG	180	98.9	246	79.7	276	73.9	522	76.6	0.62
20	IgG	180	92.2	246	96.7	276	94.2	522	95.4	0.86
21	IgG	180	95.0	246	99.6	276	96.0	522	97.7	0.93
22	IgG	168	96.0	217	97.8	267	100.0	484	99.0	0.95
23	IgG	176	94.4	244	96.0	–	–	244	96.0	0.89
24	IgG	180	46.7	246	98.0	276	98.9	522	98.5	0.53

^aFDA recommended performance thresholds (Pan Ig and IgG): Specificity ≥93%; Sensitivity ≥90%. Data highlighted in bold if below FDA recommended performance thresholds. The sensitivity measurements were not evaluated for vaccinated in anti-nucleocapsid assays as indicated by the dashes. Data analysis was performed prior to harmonization.