Traditional ELISA kit Validity Stability Test
Product Name: Human Growth Differentiation Factor 15 (GDF15) ELISA Kit
1. OD Value
OD Values contrast data was as below(Under right storage conditions):
Normal period of validity OD Values: 3.151, 2.781, 2.326, 1.851, 1.458, 1.021, 0.717, 0.08
After 12 months period of validity OD Values:3.081, 2.646, 2.212, 1.797, 1.449, 0.903, 0.433, 0.07
2. Recovery
Matrices listed below were spiked with certain level of recombinant human GDF-15 and the recovery rates were calculated by comparing the measured value to the expected amount of GDF-15 in samples.
Normal and after 12 months Normal period of validity ELISA Kit Recovery results
| Martrix |
Conditions |
Recovery range(%) |
Average(%) |
| Serum(n=6) |
normal |
88-102 |
95 |
| After 12 month |
80-100 |
90 |
| EDTA plasma(n=6) |
normal |
83-105 |
94 |
| After 12 month |
79-99 |
89 |
3. Linearity
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of human GDF-15 and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.
Normal and after 12 months Normal period of validity ELISA Kit Linearity results
| Sample |
Conditions |
1:2 |
1:4 |
1:8 |
| Serum(n=6) |
normal |
82-97% |
86-95% |
89-102% |
| After 12month |
80-88% |
82-89% |
88-101% |
| EDTA plasma(n=6) |
normal |
93-103% |
81-92% |
92-98% |
| After 12month |
79-95% |
75-88% |
77-92% |
4. Precision
CV(%) = SD/meanX100
Intra-assay Precision (Precision within one batch): 3 samples with low, middle and high level human GDF15 were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between batches): 3 samples with low, middle and high level human GDF15 were tested on 3 different plates, 8 replicates in each plate.
(Intra-assay Precision:CV<10%; Inter-assay Precision:CV<11%)
Normal and after 12 months Normal period of validity ELISA Kit Precision results
Intra-assay precision
| Conditions |
normal |
After 12month |
normal |
After 12month |
normal |
After 12month |
| sample |
1 |
1 |
2 |
2 |
3 |
3 |
| n |
20 |
20 |
20 |
20 |
20 |
20 |
| Mean(pg/ml) |
116.63 |
104.23 |
3070.21 |
2962.42 |
4369.75 |
4727.68 |
| SD |
7.58 |
7.19 |
184.21 |
239.96 |
288.4 |
397.13 |
| CV(%) |
6.5 |
6.9 |
6 |
8.1 |
6.6 |
8.4 |
Inter-assay precision
| Conditions |
normal |
After 12month |
normal |
After 12month |
normal |
After 12month |
| Sample |
1 |
1 |
2 |
2 |
3 |
3 |
| n |
20 |
20 |
20 |
20 |
20 |
20 |
| Mean(pg/ml) |
128.77 |
113.66 |
2765.98 |
2961.23 |
4387.28 |
4889.22 |
| SD |
9.92 |
9.32 |
201.92 |
233.94 |
289.56 |
415.58 |
| CV（%） |
7.7 |
8.2 |
7.3 |
7.9 |
6.6 |
8.5 |
