Table 1.

Prototype assay calibration performance summary using Quanterix standard for assay evaluation and clinical test batches

	Concentrationa (pg/ml)
Theoretical concentration	0.023	0.069	0.206	0.617	1.85	5.6	16.7	50.0
Run 1		0.096	0.199	0.616	1.85	5.56	16.9	49.9
Run 2	−0.011	0.066	0.224	0.614	1.77	5.67	17.2	49.7
Run 3	−0.032	0.135	0.281	0.613	1.78	5.56	17.4	49.5
Run 4	−0.012	0.080	0.201	0.615	1.87	5.48	16.9	49.9
Run 5	−0.074	0.103	0.218	0.602	1.85	5.54	16.9	49.9
Run 6	0.061	0.088	0.194	0.620	1.85	5.48	17.0	49.8
Run 7		0.066	0.202	0.627	1.82	5.56	16.8	49.9
Run 8		0.234	0.323	0.525	2.11	5.23	17.5	49.8
Run 9		0.214	0.240	0.583	1.82	5.43	17.8	49.2
N (total number of runs)	5	9	9	9	9	9	9	9
Inter-assay mean	−0.014	0.120	0.231	0.602	1.86	5.5	17.2	49.7
SD	0.049	0.063	0.044	0.031	0.099	0.121	0.350	0.237
CV%	−362	52.1	19.0	5.2	5.3	2.2	2.0	0.5
Inter-assay RE, %	−159	74.2	12.4	−2.5	0.4	−1.8	2.7	−0.5

CV% Coefficient of variation percentage, RE Relative error

In runs 6–8, calibration curves prepared using both Quanterix and Fujirebio standards were included

^aConcentrations were interpolated using the calibrator average enzymes per bead values against the fitted cubic curves