AFP Rapid Quantitative Test Kit(CLIA)

The performance data

Manufacturer	SEKBIO
Parameter	AFP
Linearity	0.5-1000 ng/ml
Detection limit	0.5 ng/ml
benchmark product	Roche
Test principle and procedure	AFP: Add 10 μl of sample（The sample is diluted 10 times on the machine） + 30 μl of Ra+ 30 μl of Rd incubation for 15 minutes. Wash with 200 μl of washing solution. Finally, add 100 μl of A + 100 μl of B.

Six point calibration test results

Sample Concentration(ng/ml)	RLU		Average	CV	S/N
1162.62	4,132,851	4,047,944	4,090,398	1.47%	9130.35
644.64	2,413,626	2,402,215	2,407,921	0.34%	5374.82
137.78	552,114	578,005	565,060	3.24%	1261.29
13.00	56,977	59,955	58,466	3.60%	130.50
1.24	6,176	6,306	6,241	1.47%	13.93
0.04	453	443	448	1.58%	1.00

Precision

Sample	RLU	Concentration	Sample	RLU	Concentration
13	62,373	13.90	644.64	2,418,618	647.81
	63,370	14.13		2,467,418	662.12
	59,980	13.35		2,579,205	695.05
	65,255	14.57		2,384,657	637.88
	64,991	14.51		2,548,509	685.99
	63,906	14.26		2,625,042	708.62
	60,879	13.56		2,441,908	654.64
	66,323	14.82		2,520,405	677.70
	60,793	13.54		2,560,671	689.58
	62,603	13.95		2,453,104	657.92
AVE	196,623	99.27	AVE	2,499,954	671.73
SD	2110	0.49	SD	78118	22.99
CV	1.07%	0.49%	CV	3.12%	3.42%

Limit of detection

Sample	RLU		Concentration
Ag Diluent	472	508	0.004	0.011
	365	512	0.00	0.012
	364	273	0.00	0.000
	382	392	0.00	0.000
	442	250	0.00	0.000
	301	319	0.00	0.000
	280	484	0.00	0.007
	249	446	0.00	0.000
	406	358	0.00	0.000
	377	490	0.00	0.008
AVE	916		0.09
SD	120.35		0.05
AVE+2*SD	0.19

Linear

Sample（ng/ml)	Dilution ratio	Concentration value			Average
1303.80	1.0	1239.37	1265.76	1274.24	1303.799135
1173.42	0.9	1146.01	1214.25	1094.15	1151.25
1043.04	0.8	1032.30	1129.58	1131.06	1097.45
912.66	0.7	959.27	1032.66	931.43	974.29
782.28	0.6	801.08	847.83	801.65	816.81
651.90	0.5	691.66	704.87	637.77	678.01
521.52	0.4	539.84	496.45	489.92	508.68
391.14	0.3	391.37	394.63	374.61	386.86
260.76	0.2	287.37	292.72	295.31	291.80
130.38	0.1	136.52	133.42	124.08	131.33
0.02	0	0.00	0.00	0.00	0.02

Method Comparison

Reagents Stability

Reagent	Sample(ng/ml)	Average	Deviation
2-8°	1000.00	4,619,209
	200.00	941,520
	40.00	174,592
	8.00	41,845
	1.00	6,160
	0.00	657
37℃ 1d	1000.00	4,541,645	-1.68%
	200.00	951,361	1.05%
	40.00	164,523	-5.77%
	8.00	39,680	-5.18%
	1.00	5,750	-6.66%
	0.00	781	18.87%
37℃ 4d	1000.00	4,672,586	1.16%
	200.00	946,372	-0.52%
	40.00	175,190	6.48%
	8.00	40,495	-3.23%
	1.00	5,731	-0.32%
	0.00	769	-1.54%
37℃ 7d	1000.00	4,334,765	-6.16%
	200.00	900,764	-4.33%
	40.00	152,647	-12.57%
	8.00	40,724	-2.68%
	1.00	5,335	-13.39%
	0.00	684	4.11%

Calibrator Stability

Reagent	Sample(ng/ml)	Average	Deviation
2-8℃	1000.00	4,668,604
	200.00	877,755
	40.00	184,066
	8.00	43,028
	1.00	7,215
	0.00	590
37℃ 1d	1000.00	4,643,345	1.1%
	200.00	825,354	-6.8%
	40.00	196,334	5.4%
	8.00	44,191	2.8%
	1.00	6,896	17.1%
	0.00	567	-10.3%
37℃ 4d	1000.00	4,580,588	0.5%
	200.00	1,056,764	-12.3%
	40.00	183,616	12.5%
	8.00	37,479	5.6%
	1.00	5,374	11.9%
	0.00	563	-13.7%
37℃ 7d	1000.00	3,882,314	-0.84%
	200.00	824,447	12.24%
	40.00	163,843	5.17%
	8.00	37,187	-10.43%
	1.00	5,881	-12.77%
	0.00	593	-14.31%

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