Ready-To-Use ELISA kit Validity Stability Test

Product Name: Mouse Cystatin 3 (CST3) ready-to-use ELISA Kit 
 
1. OD Value
OD Values contrast data was as below(Under right storage conditions):
7 months period of validity OD Values: 2.654, 1.780, 1.203, 0.861, 0.675, 0.492, 0.202, 0.076
13 months period of validity OD Values:2.531, 1.766, 1.273, 0.904, 0.734, 0.600, 0.488，0.077
17 months period of validity OD Values:2.451, 1.669, 1.221,  0.879, 0.656, 0.409, 0.289, 0.068
 
2. Recovery
Matrices listed below were spiked with certain level of recombinant mouse CST3 and the recovery rates were calculated by comparing the measured value to the expected amount of CST3 in samples.
 
7 months 13 months and after 17 months period of validity ELISA Kit Recovery results

Martrix	Conditions	Recovery range(%)	Average(%)
Serum(n=6)	7 months	91-103	97
	13 months	80-100	90
	17 months	81-101	91
EDTA plasma(n=6)	7 months	86-106	96
	13 months	78-98	88
	17 months	79-102	91

 
3. Linearity
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of mouse CST3 and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.
 
7 months 13 months and 17 months period of validity ELISA Kit Linearity results

Sample	Conditions	1:2	1:4	1:8
Serum(n=6)	7 months	89-99%	81-105%	90-102%
	13 months	87-95%	83-98%	86-103%
	17 months	85-97%	79-99%	82-101%
EDTA plasma(n=6)	7 months	93-104%	81-102%	92-102%
	13 months	89-94%	78-109%	90-96%
	17 months	89-95%	76-97%	89-93%

 
4. Precision
CV(%) = SD/meanX100
Intra-assay Precision (Precision within one batch): 3 samples with low, middle and high level mouse CST3 were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between batches): 3 samples with low, middle and high level mouse CST3 were tested on 3 different plates, 8 replicates in each plate.
(Intra-assay Precision:CV<10%; Inter-assay Precision:CV<11%)
 
       7 months 13 months and 17 months period of validity ELISA Kit Precision results
 
                           Intra-assay precision

Conditions	sample	n	Mean(ng/ml)	SD	CV(%)
7 months	1	20	0.268	0.02	6.27
13 months	1	20	0.352	0.02	6.83
17 months	1	20	0.125	0.01	5.98
7 months	2	20	4.89	0.34	7.01