Table 2.

Prototype assay calibration performance summary using Fujirebio 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 6	−0.006	0.097	0.262	0.584	1.83	5.65	16.6	50.1
Run 7		0.112	0.365	0.514	1.94	5.36	17.1	49.8
Run 8		0.260	0.283	0.388	1.98	5.79	16.0	50.5
N (total number of runs)	1	3	3	3	3	3	3	3
Inter-assay mean	−0.006	0.156	0.303	0.495	1.92	5.6	16.6	50.1
SD		0.090	0.054	0.100	0.077	0.220	0.508	0.365
CV%		57.9	17.9	20.1	4.0	3.9	3.1	0.7
Inter-assay RE, %	−125	128	47.5	−19.8	3.6	0.8	−0.7	0.3

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