胰島素自身抗體(IAA)檢測試劑盒
適用生物 Homo sapiens (Human，人)
胰島素自身抗體(IAA)檢測試劑盒檢測范圍 3.13-200ng/mL 靈敏度 1.15ng/mL
樣本類型 Serum, plasma and other biological fluids.
實(shí)驗(yàn)時(shí)長 4h 實(shí)驗(yàn)方法 雙抗夾心法 胰島素自身抗體(IAA)檢測試劑盒規(guī)格 96T
ELISA Kit for Insulin Autoantibody (IAA)
FOR IN VITRO AND RESEARCH USE ONLY, NOT FOR USE IN CLINICAL DIAGNOSTIC PROCEDURES!
| Organism species | Homo sapiens (Human) |
| Product No. | hzEB264Hu |
| Sample type | Serum, plasma and other biological fluids. |
| Format | 96-well strip plate |
| Assay length | 4 hours |
| Detection range | 3.13-200ng/mL The standard curve concentrations used for the ELISA’s were 200ng/mL, 100ng/mL, 50ng/mL, 25ng/mL, 12.5ng/mL, 6.25ng/mL, 3.13ng/mL |
| Sensitivity | The minimum detectable dose of this kit is typically less than 1.15ng/mL. |
胰島素自身抗體(IAA)檢測試劑盒Specificity
This assay has high sensitivity and excellent specificity for detection of Insulin Autoantibody (IAA).
No significant cross-reactivity or interference between Insulin Autoantibody (IAA) and analogues was observed.
Recovery
Matrices listed below were spiked with certain level of Insulin Autoantibody (IAA) and the recovery rates were calculated by comparing the measured value to the expected amount of Insulin Autoantibody (IAA) in samples.
| Matrix | Recovery range (%) | Average(%) |
| serum(n=5) | 98-105 | 102 |
| EDTA plasma(n=5) | 83-96 | 86 |
| heparin plasma(n=5) | 92-103 | 99 |
胰島素自身抗體(IAA)檢測試劑盒Precision
Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Insulin Autoantibody (IAA) were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Insulin Autoantibody (IAA) were tested on 3 different plates, 8 replicates in each plate.
CV(%) = SD/meanX100
Intra-Assay: CV<10%
Inter-Assay: CV<12%
Linearity
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Insulin Autoantibody (IAA) 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=5) | 96-105% | 96-103% | 95-102% | 88-101% |
| EDTA plasma(n=5) | 79-93% | 81-101% | 91-99% | 95-103% |
| heparin plasma(n=5) | 96-105% | 78-99% | 87-96% | 94-101% |
Stability
The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition.
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 also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.
Reagents and materials provided
| Reagents | Quantity | Reagents | Quantity |
| Pre-coated, ready to use 96-well strip plate | 1 | Plate sealer for 96 wells | 4 |
| Standard | 2 | Standard Diluent | 1×20mL |
| Detection Reagent A | 1×120μL | Assay Diluent A | 1×12mL |
| TMB Substrate | 1×9mL | Stop Solution | 1×6mL |
| Wash Buffer (30 × concentrate) | 1×20mL | Instruction manual | 1 |
Assay procedure summary
1. Prepare all reagents, samples and standards;
2. Add 100μL standard or sample to each well. Incubate 2 hours at 37oC;
3. Aspirate and add 100μL prepared Detection Reagent A. Incubate 1 hour at 37oC;
4. Aspirate and wash 5 times;
5. Add 90μL Substrate Solution. Incubate 15-25 minutes at 37oC;
6. Add 50μL Stop Solution. Read at 450nm immediay.
胰島素自身抗體(IAA)檢測試劑盒Test principle
The microtiter plate provided in this kit has been pre-coated with an antigen. Standards or samples are then added to the appropriate microtiter plate wells with a Horseradish Peroxidase (HRP)-conjugated secondary antibody. After TMB substrate solution is added, those wells that contain Insulin Autoantibody (IAA) will exhibit a change in color. The enzyme-substrate reaction is terminated by the addition of sulphuric acid solution and the color change is measured spectrophotometrically at a wavelength of 450nm ± 10nm. The concentration of Insulin Autoantibody (IAA) in the samples is then determined by comparing the O.D. of the samples to the standard curve.
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