TABLE 5.

Identification of factors contributing to assay performance, neutralization assay^a

	Neutralization SARS-CoV-2 serological assay specificity and sensitivity
	Specificity (%)		Sensitivity (%)						Cohen's kappa agreement
Assay ID	N	Overall	N	Infected	N	Vaccinated	N	Overall (%)	Overall
25	90	42.2	123	99.2	138	97.8	261	98.5	0.47
26	180	51.1	246	99.2	276	96.4	522	97.7	0.56
27	182	97.2	232	86.8	270	60.2	502	69.5	0.52
28	60	100.0	123	98.4	127	78.8	250	88.1	0.71
29	90	100.0	123	74.0	138	50.7	261	61.7	0.45
30	89	89.9	120	96.7	137	72.3	257	92.9	0.65
31	180	100.0	246	96.3	276	71.7	522	83.3	0.72
32	180	100.0	246	83.7	276	77.2	522	80.3	0.68
33	–	–	–	–	–	–	–	–	–

^aFDA recommended performance thresholds (Pan Ig and IgG): Specificity ≥93%; Sensitivity ≥90%. Data highlighted in bold if below FDA recommended performance thresholds. Sensitivity and specificity analysis were not evaluated for Assay ID 33 due to no reported cutoff value for the assay, and dashes were added to indicate the data was not analyzed. Data analysis was performed prior to harmonization.