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Thyroid Stimulating Hormone(TSH)

The performance data of the TSH Rapid Quantitative Test Kit (FIA)

Manufacturer	SEKBIO
Parameter	TSH Rapid Quantitative Test Kit (FIA)
Linearity	0.1~100mIU/L
Detection limit	0.1mIU/L
Benchmark product	Roche

1 Limit of detection

Result(T/C)	Concentration
Result(T/C)	0	0.095
1	0.00419	0.02036
2	0.00515	0.02371
3	0.00635	0.02259
4	0.00413	0.02374
5	0.00630	0.02306
6	0.00676	0.02266
7	0.00505	0.01894
8	0.00407	0.02162
9	0.00485	0.02047
10	0.00506	0.01839
11	0.00644	0.02016
12	0.00546	0.01944
13	0.00662	0.02195
14	0.00433	0.02323
15	0.00715	0.02202
16	0.00684	0.01759
17	0.00707	0.01824
18	0.00479	0.02329
19	0.00403	0.02233
20	0.00556	0.01998
AVE	0.00551	0.02119
SD	0.00109	/
AVE+2*SD	0.00770	/
regression equation	y=0.16504x+0.00551
LoB(mIU/L)	0.01324

2 Linear

Cal	Concentration	Result	AVERAGE
S1	0.095	0.11	0.10
		0.10
		0.10
S2	0.25	0.26	0.25
		0.23
		0.27
S3	1.05	1.05	1.04
		1.00
		1.07
S4	4.98	5.39	5.01
		4.91
		4.74
S5	25.79	28.80	27.80
		27.28
		27.33
S6	105.76	99.33	99.39
		95.29
		103.54

3 Accuracy

Cal	concentration	Result	Bias
A1	0.25	0.27	6.4%
		0.25	0.0%
		0.27	6.8%
A2	4.98	5.39	8.1%
		4.89	-1.8%
		5.00	0.4%
A3	25.79	25.31	-1.9%
		23.28	-9.7%
		27.66	7.3%

4 Precision

Cal	Concentration	Cal	Concentration	Cal	Concentration
R1	0.24	R2	4.99	R3	28.75
	0.22		4.26		26.52
	0.27		4.50		23.74
	0.27		4.50		22.26
	0.28		4.82		26.50
	0.24		5.34		24.50
	0.26		4.27		24.96
	0.26		4.63		24.09
	0.28		4.74		23.23
	0.22		5.58		27.81
AVE	0.25	AVE	4.76	AVE	25.24
SD	0.02	SD	0.43	SD	2.09
CV	8.7%	CV	9.1%	CV	8.3%

5 Method Comparison

Sample	Roche	Sekbio	Sample	Roche	Sekbio
1	19.09	18.50	31	6.17	7.42
2	91.47	80.40	32	3.53	3.41
3	4.49	4.20	33	0.39	0.45
4	65.44	65.87	34	30.57	29.70
5	0.36	0.38	35	13.47	15.61
6	0.43	0.35	36	0.11	0.13
7	0.21	0.19	37	4.22	4.63
8	0.61	0.60	38	0.87	0.78
9	3.92	4.32	39	0.65	0.56
10	5.11	5.31	40	0.49	0.51
11	1.08	1.06	41	2.03	2.13
12	0.80	0.73	42	12.18	12.11
13	4.34	4.34	43	0.20	0.22
14	0.17	0.21	44	75.73	77.74
15	9.17	8.17	45	10.34	8.79
16	13.18	14.09	46	0.42	0.43
17	36.78	32.72	47	1.10	1.04
18	17.46	17.07	48	14.29	12.47
19	1.18	1.26	49	0.68	0.69
20	0.21	0.22	50	0.24	0.25
21	2.40	2.32	51	0.27	0.24
22	15.29	15.59	52	82.21	68.58
23	1.58	1.32	53	0.70	0.81
24	0.71	0.78	54	0.58	0.56
25	0.12	0.12	55	44.59	44.46
26	24.56	20.07	56	1.37	1.38
27	1.98	2.06	57	0.19	0.20
28	11.11	10.57	58	0.56	0.47
29	0.16	0.14	59	0.16	0.16
30	1.32	1.09	60	7.86	7.44

The performance data of the TSH Rapid Quantitative Test Kit(CLIA)

Manufacturer	SEKBIO
Parameter	TSH
Linearity	0.005-100 uIU/ml
Detection limit	0.005 uIU/ml
benchmark product	Roche
Test principle and procedure	FT3: Add 50 μl of sample + 30 μl of Ra, incubation for 20 minutes with cleaning, 30 μl of Rd incubation for 5 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( uIU/ml)	RLU			Average	CV	S/N
110.39	11,427,439	11,980,528	11,766,635	11,724,867	2.38%	19827.85
15.21	1,410,817	1,416,537	1,377,243	1,401,532	1.51%	2370.12
1.90	139,436	138,028	137,566	138,343	0.70%	233.95
0.25	14,762	14,436	14,989	14,729	1.89%	24.91
0.02	1,354	1,239	1,500	1,364	9.59%	2.31
0.00	579	543	652	591	9.39%	1.00

Precision

Sample	RLU	Concentration	Sample	RLU	Concentration
0.25	16,113	0.27	15.21	1,410,817	15.30
	16,074	0.27		1,416,537	15.36
	16,762	0.28		1,377,243	14.97
	16,842	0.28		1,423,571	15.43
	15,981	0.27		1,384,751	15.05
	15,484	0.26		1,443,541	15.62
	16,897	0.28		1,466,721	15.85
	16,579	0.28		1,456,454	15.75
	16,726	0.28		1,354,581	14.75
	16,759	0.28		1,354,781	14.75
AVE	16,422	0.27	AVE	1,408,900	15.28
SD	476.00	0.01	SD	40203.16	0.39
CV	2.90%	2.69%	CV	2.85%	2.58%

Limit of detection

Sample	RLU		Concentration
Ag Diluent	557	649	0	0.001
	607	686	0	0.001
	551	648	0	0.001
	523	655	0	0.001
	701	637	0.001	0.001
	691	719	0.001	0.001
	538	521	0	0
	570	617	0	0
	557	587	0	0
	577	621	0	0
AVE	610.60		0.00
SD	61.29		0.00
AVE+2*SD	0.001

Linear

Sample（uIU/ml)	Dilution ratio	Concentration value			Average
118.221	1.0	116.05	118.43	120.19	118.22
94.58	0.8	99.06	102.22	98.16	99.81
70.94	0.6	78.09	76.34	76.26	76.90
47.30	0.4	55.24	56.58	55.31	55.71
23.66	0.2	29.17	29.48	28.69	29.11
0.02	0.0	0.02	0.02	0.02	0.02

Method Comparison

Reagents Stability

Reagent	Sample( uIU/ml)	Average	Deviation
2-8°	100.00	10,425,389
	1.00	112,861
	0.01	1,366
	Antigen diluent	898
	random sample	115,159
37℃ 1d	100.00	10,663,013	2.28%
	1.00	113,127	0.24%
	0.01	1,255	-8.13%
	Antigen diluent	768	-14.53%
	random sample	115,656	0.43%
37℃ 4d	100.00	10,239,173	-1.79%
	1.00	106,284	-5.83%
	0.01	1,193	-12.63%
	Antigen diluent	721	-19.77%
	random sample	107,584	-6.58%
37℃ 7d	100.00	9,722,196	-6.75%
	1.00	98,097	-13.08%
	0.01	1,110	-18.71%
	Antigen diluent	579	-35.58%
	random sample	98,107	-14.81%

Calibrator Stability

Reagent	Sample( uIU/ml)	Average	Deviation
2-8℃	100.00	7,930,669
	10.00	92,332
	0.10	2,336
37℃ 1d	100.00	7,824,631	-1.34%
	10.00	91,504	-0.90%
	0.10	2,275	-2.58%
37℃ 4d	100.00	7,804,914	-1.59%
	10.00	78,533	-14.94%
	0.10	2,114	-9.49%
37℃ 7d	100.00	7,952,122	0.27%
	10.00	75,605	-18.12%
	0.10	1,893	-18.94%

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