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|Detection range||0.63-40 ng/mL|
|Sample type &Sample volume||serum, plasma and other biological fluids; 100μL|
|Specificity||This kit recognizes Human IgE in samples. No significant cross-reactivity or interference between Human IgE and analogues was observed.|
|Reproducibility||Both intra-CV and inter-CV are < 15%.|
|Application||This CLIA kit applies to the in vitro quantitative determination of Human IgE concentrations in serum, plasma and other biological fluids.|
|Micro CLIA Plate(Dismountable)||96T: 8 wells ×12 strips
48T: 8 wells ×6 strips
|-20℃, 6 months|
|Reference Standard||96T: 2 vials
48T: 1 vial
|Concentrated Biotinylated Detection Ab (100×)||96T: 1 vial, 120 μL
48T: 1 vial, 60 μL
|Concentrated HRP Conjugate (100×)||96T: 1 vial, 120 μL
48T: 1 vial, 60 μL
|-20℃(Protect from light), 6 months|
|Reference Standard & Sample Diluent||1 vial, 20 mL||2-8°C, 6 months|
|Biotinylated Detection Ab Diluent||1 vial, 14 mL|
|HRP Conjugate Diluent||1 vial, 14 mL|
|Concentrated Wash Buffer (25×)||1 vial, 30 mL|
|Substrate Reagent A||1 vial, 5 mL||2-8℃(Protect from light)|
|Substrate Reagent B||1 vial, 5 mL|
|Plate Sealer||5 pieces|
|Certificate of Analysis||1 copy|
Intra-assay Precision (Precision within an assay): 3 samples with low, mid range and high level Human IgE were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, mid range and high level Human IgE were tested on 3 different plates, 20 replicates in each plate.
|Intra-assay Precision||Inter-assay Precision|
The recovery of Human IgE spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.
|Sample Type||Range (%)||Average Recovery (%)|
|Cell culture media(n=8)||90-101||95|
Samples were spiked with high concentrations of Human IgE and diluted with Reference Standard & Sample Diluent to produce samples with values within the range of the assay.
1.Add 100 μL of standard or sample to each well. Incubate for 90 min at 37℃.
2.Remove the liquid.
3.Add 100 μL Biotinylated Detection Ab. Incubate 1 hour at 37℃. Aspirate and wash 3 times.
4.Add 100 μL HRP Conjugate. Incubate 30 min at 37℃. Aspirate and wash 5 times.
5.Add 100 μL Substrate Mixture Solution. Incubate for 5 min at 37℃.
6.Fluorescence appeared. Measure the RLU value with the Chemiluminescence immunoassay analyzer. Calculation of the results.
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