Luteinizing Hormone(LH)
The performance data of the LH rapid Quantitative Test Kit (FIA)
Manufacturer | SEKBIO |
Parameter | LH Rapid Quantitative Test Kit (FIA) |
Linearity | 1~100mIU/ml |
Detection limit | 1mIU/ml |
Benchmark product | Roche |
1 Limit of detection
Result(T/C) | Concentration | |
0 | 0.98 | |
1 | 0.00209 | 0.01878 |
2 | 0.00222 | 0.01912 |
3 | 0.00196 | 0.01332 |
4 | 0.00205 | 0.01472 |
5 | 0.00179 | 0.01549 |
6 | 0.00194 | 0.01844 |
7 | 0.00189 | 0.01337 |
8 | 0.00212 | 0.01884 |
9 | 0.00173 | 0.01830 |
10 | 0.00171 | 0.01916 |
11 | 0.00218 | 0.01383 |
12 | 0.00235 | 0.01808 |
13 | 0.00207 | 0.01787 |
14 | 0.00205 | 0.01795 |
15 | 0.00207 | 0.01720 |
16 | 0.00195 | 0.01881 |
17 | 0.00200 | 0.01389 |
18 | 0.00193 | 0.01648 |
19 | 0.00201 | 0.01931 |
20 | 0.00172 | 0.01890 |
AVE | 0.00199 | 0.01709 |
SD | 0.00017 | / |
AVE+2*SD | 0.00233 | / |
regression equation | y=0.01541x+0.00199 | |
LoB(mIU/ml) | 0.02205 | |
2 Linear
Cal | Concentration | Result | AVERAGE |
S1 | 0.98 | 1.21 | 1.05 |
0.97 | |||
0.98 | |||
S2 | 3.37 | 3.48 | 3.22 |
3.20 | |||
2.99 | |||
S3 | 10.56 | 11.28 | 11.15 |
11.00 | |||
11.17 | |||
S4 | 26.24 | 25.56 | 26.01 |
25.01 | |||
27.45 | |||
S5 | 51.37 | 46.74 | 46.84 |
47.41 | |||
46.38 | |||
S6 | 107.56 | 112.74 | 104.07 |
97.03 | |||
102.43 |
3 Accuracy
Cal | concentration | Result | Bias |
A1 | 3.37 | 3.13 | -7.2% |
3.69 | 9.6% | ||
3.33 | -1.1% | ||
A2 | 10.56 | 9.79 | -7.3% |
9.56 | -9.5% | ||
11.60 | 9.8% | ||
A3 | 26.24 | 27.22 | 3.7% |
27.49 | 4.8% | ||
26.51 | 1.0% |
4 Precision
Cal | Concentration | Cal | Concentration | Cal | Concentration |
R1 | 3.79 | R2 | 9.26 | R3 | 22.99 |
3.62 | 10.41 | 23.00 | |||
3.33 | 9.84 | 22.83 | |||
3.07 | 11.07 | 22.69 | |||
3.86 | 10.09 | 24.37 | |||
3.63 | 11.11 | 28.38 | |||
2.95 | 11.28 | 29.52 | |||
3.84 | 11.79 | 25.89 | |||
3.45 | 11.72 | 23.66 | |||
2.97 | 9.15 | 28.32 | |||
AVE | 3.45 | AVE | 10.57 | AVE | 25.16 |
SD | 0.35 | SD | 0.96 | SD | 2.66 |
CV | 10.3% | CV | 9.1% | CV | 10.6% |
5 Method Comparison
Sample | Roche | Sekbio | Sample | Roche | Sekbio |
1 | 52.11 | 54.44 | 31 | 33.02 | 38.04 |
2 | 62.92 | 65.86 | 32 | 21.78 | 19.83 |
3 | 20.25 | 23.69 | 33 | 6.40 | 6.90 |
4 | 87.82 | 85.45 | 34 | 99.12 | 90.53 |
5 | 3.42 | 4.04 | 35 | 43.32 | 41.37 |
6 | 11.09 | 10.41 | 36 | 2.07 | 1.69 |
7 | 2.27 | 2.10 | 37 | 16.25 | 14.58 |
8 | 8.67 | 9.09 | 38 | 6.39 | 6.31 |
9 | 11.54 | 11.23 | 39 | 7.11 | 7.04 |
10 | 14.60 | 16.56 | 40 | 8.08 | 9.24 |
11 | 4.92 | 4.16 | 41 | 17.45 | 15.90 |
12 | 5.96 | 5.05 | 42 | 45.98 | 40.02 |
13 | 15.00 | 18.09 | 43 | 2.51 | 2.85 |
14 | 1.48 | 1.54 | 44 | 58.44 | 68.07 |
15 | 43.04 | 36.43 | 45 | 29.24 | 29.66 |
16 | 48.27 | 48.55 | 46 | 7.64 | 6.87 |
17 | 52.55 | 43.44 | 47 | 7.65 | 6.73 |
18 | 47.63 | 46.05 | 48 | 34.46 | 37.80 |
19 | 11.78 | 10.65 | 49 | 7.24 | 7.15 |
20 | 2.98 | 3.15 | 50 | 3.10 | 2.51 |
21 | 20.70 | 22.93 | 51 | 9.33 | 9.52 |
22 | 31.06 | 33.59 | 52 | 51.29 | 53.33 |
23 | 21.89 | 21.80 | 53 | 4.82 | 4.86 |
24 | 6.95 | 8.15 | 54 | 4.72 | 4.80 |
25 | 3.97 | 3.38 | 55 | 76.36 | 72.13 |
26 | 37.74 | 38.79 | 56 | 14.28 | 13.81 |
27 | 21.95 | 19.34 | 57 | 3.74 | 3.60 |
28 | 42.94 | 46.80 | 58 | 10.51 | 8.91 |
29 | 1.53 | 1.65 | 59 | 2.83 | 2.75 |
30 | 13.98 | 15.00 | 60 | 31.40 | 28.67 |
The performance data of the LH Rapid Quantitative Test Kit(CLIA)
Manufacturer | SEKBIO |
Parameter | LH |
Linearity | 0.1-200 mIU/mL |
Detection limit | 0.1 mIU/mL |
benchmark product | Roche |
Test principle and procedure | PG Ⅱ: Add 35 μl of sample + 30 μl of Ra +30 μl of Rd and 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(mIU/mL) | RLU | Average | CV | S/N | |
219.85 | 3,101,159 | 3,280,048 | 3,190,604 | 3.96% | 7169.9 |
188.08 | 2,780,782 | 2,679,790 | 2,730,286 | 2.62% | 6135.5 |
78.25 | 957,837 | 924,700 | 941,269 | 2.49% | 2115.2 |
17.68 | 107,259 | 112,512 | 109,886 | 3.38% | 246.9 |
4.03 | 12,231 | 12,125 | 12,178 | 0.62% | 27.4 |
0.14 | 422 | 468 | 445 | 7.31% | 1.0 |
Precision
Sample | RLU | Concentration | Sample | RLU | Concentration |
4.03 | 11,406 | 3.85 | 78.25 | 975,722 | 80.37 |
12,213 | 4.04 | 939,999 | 78.18 | ||
11,134 | 3.79 | 924,754 | 77.24 | ||
10,887 | 3.73 | 943,991 | 78.43 | ||
10,502 | 3.64 | 949,239 | 78.75 | ||
11,261 | 3.82 | 946,420 | 78.57 | ||
11,311 | 3.83 | 997,573 | 81.71 | ||
12,311 | 4.06 | 967,323 | 79.86 | ||
10,525 | 3.65 | 933,076 | 77.75 | ||
10,416 | 3.62 | 956,326 | 79.18 | ||
AVE | 2,353 | 77.66 | AVE | 671,260 | 4923.57 |
SD | 664.89 | 0.15 | SD | 21653.14 | 1.33 |
CV | 4.78% | 2.43% | CV | 2.05% | 1.94% |
Limit of detection
Sample | RLU | Concentration | ||
Ag Diluent | 266 | 352 | 0 | 0 |
298 | 331 | 0 | 0 | |
322 | 332 | 0 | 0 | |
275 | 344 | 0 | 0 | |
342 | 315 | 0 | 0 | |
331 | 324 | 0 | 0 | |
284 | 311 | 0 | 0 | |
283 | 353 | 0 | 0 | |
290 | 344 | 0 | 0 | |
298 | 342 | 0 | 0 | |
AVE | 316.85 | 0.000 | ||
SD | 27.16 | 0.00 | ||
AVE+2*SD | 0.00 | |||
Linear
Sample（mIU/mL) | Dilution ratio | Concentration value | Average | ||
227.24 | 1.00 | 227.21 | 220.56 | 234.09 | 227.24 |
181.84 | 0.80 | 171.25 | 167.33 | 175.32 | 171.29 |
136.44 | 0.60 | 126.01 | 122.00 | 121.84 | 123.28 |
91.05 | 0.40 | 76.74 | 78.14 | 77.96 | 77.61 |
45.65 | 0.20 | 37.74 | 36.85 | 35.85 | 36.82 |
1.73 | 0.00 | 1.78 | 1.68 | 1.74 | 1.73 |
Method Comparison
Reagents Stability
Reagent | Sample(mIU/mL) | Average | Deviation |
2-8° | 170.00 | 5,389,265 | |
85.00 | 2,225,078 | ||
17.00 | 171,144 | ||
1.00 | 3,472 | ||
0.20 | 827 | ||
0.00 | 303 | ||
37℃ 1d | 170.00 | 4,758,792 | 9 |
85.00 | 2,161,877 | -2.84% | |
17.00 | 162,426 | -5.09% | |
1.00 | 3,354 | -3.40% | |
0.20 | 867 | 4.84% | |
0.00 | 430 | 41.75% | |
37℃ 4d | 170.00 | 4,862,878 | -9.77% |
85.00 | 1,841,346 | -14.83% | |
17.00 | 142,152 | -12.48% | |
1.00 | 3,106 | -7.41% | |
0.20 | 909 | 4.79% | |
0.00 | 339 | -21.07% | |
37℃ 7d | 170.00 | 4,761,165 | -11.65% |
85.00 | 1,789,463 | -19.58% | |
17.00 | 142,410 | -16.79% | |
1.00 | 2,862 | -17.58% | |
0.20 | 836 | 1.03% | |
0.00 | 362 | 19.47% |
Calibrator Stability
Reagent | Sample(mIU/mL) | Average | Deviation |
-20℃ | 170.00 | 5,839,028 | |
85.00 | 2,228,814 | ||
17.00 | 178,217 | ||
1.00 | 4,535 | ||
0.20 | 929 | ||
0.00 | 418 | ||
2-8℃ | 170.00 | 5,337,067 | -8.60% |
85.00 | 2,227,432 | -0.06% | |
17.00 | 178,217 | 0.00% | |
1.00 | 4,432 | -2.26% | |
0.20 | 809 | -12.92% | |
0.00 | 365 | -12.83% | |
37℃ 4d | 170.00 | 5,406,979 | 1.31% |
85.00 | 2,131,325 | -4.31% | |
17.00 | 150,220 | -15.71% | |
1.00 | 4,200 | -5.23% | |
0.20 | 724 | -10.55% | |
0.00 | 304 | -16.73% | |
37℃ 7d | 170.00 | 5,313,037 | -9.01% |
85.00 | 2,149,188 | -3.57% | |
17.00 | 165,412 | -7.19% | |
1.00 | 3,953 | -12.82% | |
0.20 | 837 | -9.94% | |
0.00 | 282 | -32.67% | |
37℃ 7d | 170.00 | 5,013,782 | -14.13% |
85.00 | 2,220,288 | -0.32% | |
17.00 | 176,126 | -1.17% | |
1.00 | 3,861 | -12.88% | |
0.20 | 834 | 3.13% | |
0.00 | 221 | -39.49% |
