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武漢紐斯特生物科技有限公司
武漢紐斯特生物科技有限公司
Product:SARS-CoV-2NproteinELISAKitCatalogNO
Product: SARS-CoV-2 N protein ELISA Kit
Catalog NO.: NE-xg-E001
Assay Type: Sandwich
Research Area: Infection immunity
Detection Range: 125 -8,000 pg/mL
Sensitivity: 38.74 pg/mL
Standard Preparation
Reconstitute the Standard with 1.0 mL of Universal Diluent, keep for 10 minutes at room temperature, shake gently(not to foam). The concentration of the
standard in the stock solution is 8,000 pg/mL. Please prepare 7 tubes containing 0.5 mL Universal Diluent and produce a double dilution series according to the picture shown below. Mix each tube thoroughly
before the next transfer. Set up 7 points of diluted standard such as 8,000 pg/mL, 4,000 pg/mL, 2,000 pg/mL,
1,000 pg/mL, 500 pg/mL, 250 pg/mL, 125 pg/mL, and the last EP tube with Universal Diluent is the blank as 0 pg/mL.
Typical Data
As the OD values of the standard curve may vary according to the conditions of the objective assay,
the experimenter should fit a standard curve for each test. Typical standard curve provided below is for reference only.
Specificity
This assay has high sensitivity and excellent specificity for detection of SARS-CoV-2 N protein. No significant
cross-reactivity or interference between SARS-CoV-2 N protein ａnd analogues is observed.
Note: Limited by current skills and knowledge, it is impossible for us to complete the cross-reactivity detection
between SARS-CoV-2 N protein and all the analogues, therefore, cross reaction may still exist.
Recovery
Matrices listed below were spiked with certain level of recombinant SARS-CoV-2 N protein and the recovery rates were calculated by comparing the measured value to the expected amount of
SARS-CoV-2 N protein in samples.
Matrix | Recovery range(%) | Average(%) |
Serum(n=10) | 83-107 | 95 |
EDTA plasma(n=10) | 82-94 | 85 |
Heparin plasma(n=10) | 83-99 | 91 |
Linearity
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of
SARS-CoV-2N protein and their serial dilutions. The results were demonstrated by the percentage of calculated
concentration to the expected.
Sample | 1:2 | 1:4 | 1:8 | 1:16 |
Serum(n=10) | 83-95% | 89-103% | 82-99% | 79-107% |
EDTA plasma(n=10) | 92-104% | 91-99% | 78-98% | 80-94% |
Heparin plasma(n=10) | 86-105% | 89-102% | 81-97% | 85-92% |
Precision
Intra-assay Precision (Precision within an assay): Three samples with low, middle and high level SARS-CoV-2 N protein were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): Three samples with low, middle and high level SARS-CoV-2 N protein were tested on 3 different plates, 8 replicates in each plate.
CV (%) = SD/meanX100
Intra-Assay: CV< 10%
Inter-Assay: CV< 12%
Stability
The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% within the expiration date under appropriate storage condition.
Main components | 37℃ for 7 days | -20℃ for 12 months |
Average(%) | 90 | 95-100 |
To minimize extra influence on the performance, operation procedures and lab conditions,
especially room temperature, air humidity, incubator temperature should be strictly controlled. It is strongly
suggested that the same operator performs the whole assay from the beginning to the end.
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