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: 3.251, 2.845, 2.126, 1.859, 1.463, 1.022, 0.710, 0.08
After 12 months period of validity OD Values:3.1.7, 2.643, 2.125, 1.796, 1.453, 0.876, 0.432, 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	88-106	95
	After 12 month	80-100	87
EDTA plasma(n=6)	normal	88-106	97
	After 12 month	78-98	87

 
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	81-92%	85-90%	89-105%
	After 12month	80-88%	82-87%	87-101%
EDTA plasma(n=6)	normal	93-104%	81-97%	91-96%
	After 12month	82-95%	75-82%	74-90%

 
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(ng/ml)	16.68	14.22	70.25	62.36	369.75	327.88
SD	1.08	1.25	4.21	5.31	24.69	32.87
CV(%)	6.5	8.8	6.0	8.5	6.6	10

 
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(ng/ml)	18.72	13.68	65.98	61.25	387.22	425.26
SD	1.45	1.52	4.83	5.18	28.49	36.87
CV（%）	7.7	11.1	7.3	8.5	7.3	8.7

 
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