Table 2.

Validation results for bench-top and post-preparative stability (n = 3)

Analyte	QC level	4 °C 6 weeks		Ambient temperature without daylight (24 h)		Ambient temperature with daylight (48 h)		Ambient temperature without daylight (48 h)		Incubation at 56 °C (1 h)		Autosampler (24 h)
		Accuracy (%)	CV%	Accuracy (%)	CV%	Accuracy (%)	CV%	Accuracy (%)	CV%	Accuracy (%)	CV%	Accuracy (%)	CV%
AFA	QC-H	66.1 ± 1.38	2.08	90.2 ± 3.34	3.71	83.5 ± 0.46	0.55	81.3 ± 3.41	4.19	86.3 ± 0.99	1.15	98.1 ± 4.73	4.82
	QC-L	38.9 ± 0.42	1.08	72.8 ± 3.50	4.80	63.7 ± 5.05	7.93	63.0 ± 0.78	1.24	94.9 ± 4.31	4.55	98.0 ± 6.10	6.23
AXI	QC-H	101.6 ± 3.11	3.07	99.9 ± 0.51	0.01	89.9 ± 1.38	1.53	96.9 ± 1.93	1.99	86.8 ± 0.57	0.65	98.7 ± 3.36	3.40
	QC-L	100.0 ± 3.83	3.83	93.7 ± 2.82	3.01	90.9 ± 2.32	2.55	97.7 ± 1.68	1.72	96.9 ± 1.48	1.53	97.9 ± 3.68	3.75
BOS	QC-H	102.1 ± 4.54	0.04	102.7 ± 0.14	0.14	100.7 ± 4.66	4.62	106.7 ± 1.42	1.33	95.7 ± 0.57	0.59	98.2 ± 3.59	3.66
	QC-L	97.9 ± 3.66	0.04	91.7 ± 6.40	6.99	96.3 ± 5.13	5.33	99.7 ± 2.56	2.56	102.8 ± 6.01	5.85	99.4 ± 2.95	2.96
CAB	QC-H	101.0 ± 1.70	1.68	96.0 ± 6.50	6.77	96.3 ± 0.82	0.85	96.7 ± 0.58	0.60	91.2 ± 3.96	4.34	94.5 ± 3.33	3.52
	QC-L	99.6 ± 0.57	0.57	98.3 ± 1.09	1.11	99.8 ± 2.79	2.79	98.4 ± 0.76	0.77	99.1 ± 1.34	1.36	91.2 ± 2.13	2.33
DAB	QC-H	98.3 ± 1.28	1.30	102.5 ± 4.54	4.43	98.5 ± 2.56	2.60	99.6 ± 1.18	1.19	94.3 ± 0.71	0.75	105.2 ± 3.50	3.32
	QC-L	94.4 ± 2.57	2.72	95.3 ± 3.61	3.79	98.8 ± 2.33	2.36	100.4 ± 1.42	1.41	99.5 ± 0.78	0.78	103.9 ± 4.74	4.56
LEN	QC-H	104.6 ± 1.19	1.14	108.0 ± 5.77	5.32	103 .9 ± 1.53	1.47	104.3 ± 0.34	0.32	90.7 ± 0.49	0.55	111.6 ± 6.08	5.45
	QC-L	99.1 ± 5.73	5.78	97.2 ± 5.59	5.76	96.3 ± 1.90	0.81	98.9 ± 0.81	0.82	94.0 ± 0.00	0.00	110.3 ± 3.79	3.43
NIL	QC-H	103.1 ± 4.60	4.47	105.2 ± 5.30	5.04	102.0 ± 3.01	2.96	104.1 ± 0.59	0.57	97.9 ± 0.85	0.87	96.1 ± 3.33	3.47
	QC-L	103.3 ± 1.00	0.97	94.1 ± 3.90	4.15	99.9 ± 2.24	2.25	97.7 ± 2.48	2.54	98.7 ± 0.71	0.72	97.1 ± 6.41	6.60
OSIa	QC-H	90.3 ± 3.00	3.32	–	–	6.24 ± 0.04	0.58	3.51 ± 0.27	7.58	26.6 ± 0.72	2.70	92.4 ± 2.87	3.11
	QC-L	87.9 ± 0.00	0.00	–	–	n.a.b	n.a.b	n.a.b	n.a.b	n.a.b	n.a.b	98.5 ± 2.35	2.39
RUX	QC-H	102.1 ± 2.29	2.25	95.5 ± 5.38	5.63	99.3 ± 2.61	2.63	98.5 ± 0.88	0.90	92.4 ± 2.55	2.75	92.7 ± 1.53	1.65
	QC-L	100.9 ± 4.16	4.12	98.2 ± 2.07	2.11	99.3 ± 0.46	0.46	98.8 ± 1.70	1.72	97.0 ± 5.66	5.83	93.4 ± 6.47	6.93
TRA	QC-H	99.1 ± 0.44	0.45	100.2 ± 0.63	0.63	100.8 ± 2.43	2.41	100.5 ± 1.70	1.69	94.6 ± 1.56	1.64	99.2 ± 3.27	3.30
	QC-L	105 .9 ± 0.70	0.66	89.8 ± 1.64	1.82	95.3 ± 2.54	2.67	96.6 ± 2.68	2.77	98.5 ± 3.54	3.59	93.6 ± 2.21	2.36

^aConditions varied in the case of OSI: 4 °C for 24 h, ambient temperature w/ and w/o daylight for 24 h

^bBelow LLOQ (6 ng/mL)