Table 3.

Determination of assay sensitivity, LPC, and HPC titer control acceptable range.

Run No.	Screening assay				Confirmatory assay				HPC titer control
	QC	Conc. (ng/mL)	SNR	S-sensitivity	QC	Conc. (ng/mL)	Inhibition (%)	C-sensitivity	QC	Dilution factor	SNR	Dilution factor	HPC titer
7	PC7	10.0	1.16	6	PC 7	10.0	13.90	9	PC6	32	1.30	32	640
	PC8	5.0	1.07		PC 8	5.0	5.72		PC7	64	1.16
8	PC7	10.0	1.08	10	PC6	20.0	19.55	12	PC6	32	1.19	32	640
	PC8	5.0	1.02		PC7	10.0	10.94		PC7	64	1.08
9	PC7	10.0	1.08	10	PC6	20.0	16.21	15	PC5	16	1.34	16	320
	PC8	5.0	1.03		PC7	10.0	8.83		PC6	32	1.16
10	PC6	20.0	1.14	15	PC 6	20.0	15.21	18	PC5	16	1.26	16	320
	PC7	10.0	1.03		PC7	10.0	3.70		PC6	32	1.14
13	PC7	10.0	1.08	10	PC6	20.0	22.61	14	PC6	16	1.25	16	320
	PC8	5.0	1.03		PC7	10.0	5.65		PC7	64	1.08
14	PC7	10.0	1.11	8	PC6	20.0	14.63	14	PC6	32	1.20	32	640
	PC8	5.0	1.05		PC7	10.0	11.40		PC7	64	1.11
15	PC8	5.0	1.13	4	PC8	5.0	13.47	5	PC6	32	1.29	32	640
	PC9	2.5	0.98		PC9	2.5	2.54		PC7	64	1.13
16	PC6	20.0	1.17	11	PC7	10.0	12.67	10	PC6	32	1.17	32	640
	PC7	10.0	1.07		PC8	5.0	5.49		PC7	64	1.07
17	PC7	10.0	1.10	*	PC8	5.0	12.74	5	PC6	32	1.22	32	640
	PC9	2.5	1.02		PC9	2.5	1.00		PC7	64	1.10
18	PC7	10.0	1.11	8	PC7	10.0	13.42	9	PC6	32	1.21	32	640
	PC8	5.0	1.05		PC8	5.0	5.78		PC7	64	1.11
19	PC6	20.0	1.19	11	PC6	20.0	18.32	13	PC6	32	1.19	32	640
	PC7	10.0	1.07		PC7	10.0	10.04		PC7	64	1.07
20	PC7	10.0	1.14	6	PC7	10.0	15.95	7	PC6	32	1.27	32	640
	PC8	5.0	1.07		PC8	5.0	10.51		PC7	64	1.14
21	PC7	10.0	1.11	6	PC7	10.0	13.11	9	PC6	32	1.24	32	640
	PC8	5.0	1.07		PC8	5.0	8.67		PC7	64	1.11
22	PC8	5.0	1.09	5	PC8	5.0	13.64	5	PC6	32	1.32	32	640
	PC9	2.5	1.01		PC9	2.5	8.59		PC7	64	1.16
23	PC7	10.0	1.10	9	PC7	10.0	15.32	8	PC6	32	1.21	32	640
	PC8	5.0	1.02		PC8	5.0	7.18		PC7	64	1.10
24	PC7	10.0	1.08	10	PC6	20.0	16.72	13	PC5	16	1.35	16	320
	PC8	5.0	1.05		PC7	10.0	11.22		PC6	32	1.16
25	PC8	5.0	1.16	4	PC8	5.0	15.85	4	PC6	32	1.21	32	640
	PC9	2.5	1.01		PC9	2.5	3.21		PC7	64	1.16
26	PC8	5.0	1.09	4	PC7	10.0	13.83	7	PC6	32	1.26	32	640
	PC9	2.5	1.05		PC8	5.0	11.79		PC7	64	1.13
27	PC7	10.0	1.08	10	PC4	80.0	21.23	57	PC6	32	1.17	32	640
	PC8	5.0	1.06		PC5	40.0	6.15		PC7	64	1.08
28	PC6	20.0	1.13	14	PC5	40.0	16.22	23	PC5	16	1.21	16	320
	PC7	10.0	1.05		PC6	20.0	11.96		PC6	32	1.13
29	PC8	5.0	1.09	4	PC6	20.0	14.72	14	PC6	32	1.18	32	640
	PC9	2.5	1.07		PC7	10.0	11.07		PC7	64	1.10
30	PC8	5.0	1.10	4	PC5	40.0	25.55	*	PC5	16	1.35	/	*
	PC9	2.5	1.04		PC7	10.0	10.17		PC7	64	1.10
31	PC7	10.0	1.10	7	PC5	40.0	16.42	25	PC5	16	1.23	16	320
	PC8	5.0	1.07		PC6	20.0	11.26		PC6	32	1.12
32	PC6	20.0	1.11	14	PC5	40.0	15.47	31	PC5	16	1.18	16	320
	PC7	10.0	1.06		PC6	20.0	8.84		PC6	32	1.11
33	PC6	20.0	1.09	15	PC5	40.0	19.98	28	PC5	16	1.30	16	320
	PC7	10.0	1.07		PC6	20.0	7.59		PC6	32	1.09
34	PC6	20.0	1.09	19	PC6	20.0	14.69	17	PC5	16	1.21	16	320
	PC7	10.0	1.02		PC7	10.0	7.25		PC6	32	1.09
35	PC6	20.0	1.15	12	PC6	20.0	15.60	17	PC5	16	1.32	16	320
	PC7	10.0	1.06		PC7	10.0	5.27		PC6	32	1.15
36	PC6	20.0	1.14	11	PC7	10.0	14.79	9	PC5	16	1.31	16	320
	PC7	10.0	1.07		PC8	5.0	5.50		PC6	32	1.14
37	PC8	5.0	1.11	4	PC7	10.0	13.23	7	PC6	32	1.17	32	640
	PC9	2.5	0.98		PC8	5.0	12.23		PC7	64	1.11
Screening sensitivity			16		Confirmatory sensitivity			33	Median				640
Screening LPC			19		Confirmatory LPC			41	HPC titer control acceptable range: 320–1280

Note: *As the CV value of duplicate wells exceeded 20%, the two dilutions spanning the cut points are discontinuous and the assay data were removed from the result of the S-sensitivity, C-sensitivity, and HPC titer columns. LPC: low positive control; HPC: high positive control. SNR: sample-to-noise ratio.