Table 2.

Linearity and AMR validation results of the Alinity i system.

Assay	Unit	Testing Material	Manufacture’s claimed AMR		Validated AMR		Best fit	Non-linearity (%)	Recovery (%)
			Low	High	Low	High
TSH	uIU/mL	Serum	0.0083	100	0.0207	85.2935	3rd order	−3.8	100.0–105.5
TT3	ng/mL	Validate	0.4	6.0	0.43	5.80	3rd order	−5.1	93.9–100.3
FT3	pg/mL	Validate	1.5	20.0	0.78	19.94	3rd order	−5.2	93.0–102.3
TT4	ug/dL	Calibrator	3.0	24.0	3.21	23.68	2nd order	5.9	94.1–100.0
FT4	ng/dL	Validate	0.42	5.0	0.43	4.28	3rd order	3.6	97.0–104.3
Anti-TPO	IU/mL	Serum	3.0	1000	3.68	977.91	3rd order	−2.6	97.0–100.0
AFP	ng/mL	Serum	2	2000	2.16	1641.21	3rd order	4.3	92.9–100.0
CEA	ng/mL	Validate	1.73	1500	2.09	1266.41	2nd order	−2.5	95.5–100.0
CA 19-9	U/mL	Validate	2.06	1200	1.24	1195.19	2nd order	−5.7	93.1–100.0
CA 125	U/mL	Calibrator	1.1	1000	1.00	988.9	3rd order	−2.8	100.0–106.2
CA 15-3	U/mL	Serum	0.6	800	0.65	682.23	3rd order	5.6	93.0–100.0
HE 4	pmol/L	Calibrator	20	1500	2.33	1337.25	2nd order	−3.2	100.0–106.0
TPSA	ng/mL	Validate	0.025	100	0.029	79.339	Linear	N/A	100.0–104.5
FPSA	ng/mL	Validate	0.021	30	0.023	26.810	2nd order	−1.4	98.3–100.9
Testosterone	ng/mL	Validate	0.04	18.62	0.19	15.31	3rd order	−2.4	96.4–101.0
Progesterone	ng/mL	Validate	0.5	40	0.30	33.50	Linear	N/A	98.8–100.0
E2	pg/mL	Serum	24	1000	24.0	1000.0	Linear	N/A	100.0–108.8
Prolactin	ng/mL	Validate	0.82	200	0.68	199.97	2nd order	−7.3	91.7–100.0
b-HCG	mIU/mL	Calibrator	2.3	15,000	2.22	14509.89	3rd order	−2.4	97.8–102.7
FSH	ng/mL	Validate	0.11	150.0	0.05	130.88	Linear	N/A	99.2–100.5
LH	mIU/mL	Calibrator	0.12	250	0.48	247.88	3rd order	6.7	98.1–109.0
Cortisol	ug/dL	Serum	1.0	59.8	1.10	44.10	3rd order	24.1a	96.3–101.6
hsTnI	pg/mL	Calibrator	10	50,000	1.48	46497.08	2nd order	5.0	100.0–106.5
BNP	pg/mL	Calibrator	10	5000	6.00	4999.73	3rd order	7.9	98.5–108.6
Ferritin	ng/mL	Validate	1.98	1675.56	1.78	1605.82	3rd order	6.2	93.9–107.9
iPTH	pg/mL	Calibrator	3.0	3000	3.73	2691.70	3rd order	8.9	100.0–109.7
Folate	ng/mL	Validate	2.2	20	1.98	14.08	3rd order	5.9	92.8–101.5
Vitamin B12	pg/mL	Validate	148	2000	154.50	1954.00	2nd order	−6.2	97.5–108.7
Vitamin D	ng/mL	Calibrator	3.5	154.2	3.15	111.90	2nd order	−7.3	90.1–100.0
C-peptide	ng/mL	Serum	0.03	30	0.18	36.93	2nd order	−1.6	100.0–102.8
Homocyteine	umol/L	Serum	0.1	50	1.3	35.10	Linear	N/A	97.8–100.0

^aMaterials which have showed non-linearity larger than 10% at the lowest concentration. However, the recovery was within acceptable limit for all concentration levels.