AMH Rapid Quantitative Test Kit (CLIA)

The performance data

Manufacturer	SEKBIO
Parameter	AMH
Linearity	0.01-23ng/ml
Detection limit	0.01ng/ml
benchmark product	Roche
Test principle and procedure	AMH: Add 30 μl of sample + 30 μl of Ra +30 μl of Rd and incubation for 10 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
25.52	1,451,207	1,509,238	1,470,757	1,477,067	2.79%	6249.93
12.82	760,735	770,216	757,399	762,783	0.89%	3227.57
6.25	373,341	365,537	388,423	375,767	1.42%	1589.99
2.34	144,041	137,127	139,993	140,387	3.49%	594.02
0.12	7,352	7,608	6,823	7,261	2.65%	30.72
0.00	232	242	235	236	3.01%	1.00

Precision

Sample	RLU	Concentration	Sample	RLU	Concentration
0.1	6,905	0.11	6.25	382,945	6.37
	6,952	0.12		395,880	6.59
	6,918	0.11		402,566	6.70
	6,960	0.12		386,642	6.43
	6,917	0.11		380,176	6.33
	6,898	0.11		380,164	6.33
	7,012	0.12		392,422	6.53
	7,183	0.12		396,679	6.60
	6,816	0.11		391,700	6.52
	7,335	0.12		390,734	6.50
AVE	6,990	0.12	AVE	389,991	6.490
SD	154.77	0.00	SD	7458.69	0.12
CV	2.21%	2.27%	CV	1.91%	1.92%

Limit of detection

Sample	RLU		Concentration
Ag Diluent	227	232	0	0
	237	224	0	0
	198	254	0	0.001
	223	255	0	0.001
	223	211	0	0
	224	200	0	0
	204	255	0	0.001
	227	222	0	0
	203	237	0	0.001
	211	221	0	0
AVE	224.40		0.000
SD	17.30		0.00
AVE+2*SD	0.001

Linear

Sample（ng/ml)	Dilution ratio	Concentration value			Average
25.58	1.00	25.31	26.08	25.34	25.58
20.47	0.80	20.40	22.79	21.84	21.68
15.35	0.60	14.38	14.42	14.60	14.47
10.24	0.40	10.84	10.85	10.56	10.75
5.13	0.20	5.32	5.52	5.85	5.56
0.01	0.00	0.01	0.01	0.01	0.01

Method Comparison

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