Table 1: Results for the various coating conditions.

Attribute

Coating buffer pH 9.5 (µg/mL)

Coating buffer pH 7.2 (µg/mL)

1

5

10

20

1

5

10

20

OD of D1 (4.6 mU FXI/mL)

1.377

1.367

1.437

1.507

1.220

1.230

1.259

1.305

Blank to D1 ratio (%)

0.80

0.80

0.97

1.00

0.98

0.89

0.95

1.69

Slope
(dose-response curve D1-D6)

0.8531

0.8642

0.8698

0.8770

0.8739

0.8688

0.8720

0.8894

Correlation coefficient r

0.9984

0.9996

0.9996

0.9995

0.9983

0.9995

0.9993

0.9989

Relative total error (RTE)

15.0

7.4

7.2

8.4

15.2

8.3

9.4

12.1

OD/mU FXI

0.409

0.382

0.394

0.409

0.353

0.344

0.354

0.356

Remarks: Coating buffer with pH values of 9.5 and 7.2 was used to coat anti-FXI IgG concentrations of 1 to 20 μg/mL. OD gives the blank-corrected ODs. The dose-response curves, obtained for the human reference plasma preparation, combined FXI concentrations ranging from 0.14 (D6) to 4.6 (D1) mU FXI/mL. The attribute OD/mU FXI was calculated by insertion into the equation of the log-log regression curve.