Table 1.

Assay accuracy and precision validation results: 1a Standard performance from 5 validation runs. Linear regression curves were fit with 1/x² weighting. 1b Quality control performance at 5 quality control concentrations.

a. Back Calculated Calibration Standards	TFV	FTC
Calibration Standard Range	2.5 to 1000 ng/mL	2.5 to 5000 ng/mL
Interassay Accuracy (% Dev ) (n=5)	−7.9% to 5.4%	−7.2% to 4.8%
Interassay Precision (%CV ) (n=5)	2.7% to 7.1%	2.0% to 6.5%
Slope Mean (n=5)	6.79E-03	6.11E-03
Slope Precision (n=5)	11.7%	7.90%
Coefficient of Determination (r^2) Mean (n=5)	0.9952	0.9959

b. Quality Control Accuracy and Precision	TFV	FTC
Quality Control Level 1 (LLOQ)	2.5 ng/mL	2.5 ng/mL
Interassay Accuracy (%Dev) (n=25)	−1.4	3.1
Interassay Precision (%CV) (n=25)	13.3	9.1
Intraassay Accuracy (%Dev)(n=5)	−14.6 to 10.0	−1.4 to 8.0
Intraassay Precision (%CV) (n=5)	4.1 to 18.8	5.4 to 12.0
Quality Control Level 2	5.0 ng/mL	5.0 ng/mL
Interassay Accuracy (%Dev) (n=25)	5.2	0.1
Interassay Precision (%CV) (n=25)	9.1	6.6
Intraassay Accuracy (%Dev)(n=5)	−1.1 to12.0	−3.8 to 6.0
Intraassay Precision (%CV) (n=5)	5.0 to12.4	4.0 to 7.2
Quality Control Level 4	15 ng/mL	15 ng/mL
Interassay Accuracy (%Dev) (n=25)	3.3	0.9
Interassay Precision (%CV) (n=25)	6.0	5.6
n I traassay Accuracy (%Dev)(n=5)	−1.7 to 7.2	−1.8 to 6.4
Intraassay Precision (%CV) (n=5)	3.8 to 8.1	2.8 to 7.0
Quality Control Level 5	200 ng/mL	400 ng/mL
Interassay Accuracy (%Dev) (n=25)	3.1	−0.4
Interassay Precision (%CV) (n=25)	5.4	4.5
Intraassay Accuracy (%Dev)(n=5)	−2.5 to 7.7	−3.0 to 5.5
Intraassay Precision (%CV) (n=5)	1.5 to 6.9	1.4 to 4.4
Quality Control Level 6	800 ng/mL	4000 ng/mL
Interassay Accuracy (%Dev) (n=25)	7.1	3.9
Interassay Precision (%CV) (n=25)	8.0	5.5
Intraassay Accuracy (%Dev)(n=5)	−1.7 to 14.5	0.8 to 7.4
Intraassay Precision (%CV) (n=5)	4.1 to 6.5	3.5 to 7.3