Omalizumab (Xolair®)药代动力学ELISA试剂盒

抗原（Antigen）：Omalizumab (Xolair)
反应性（Reactivity）：Human, mouse, rat
特异性（Specificity）：Omalizumab
检测范围（Detection range）：50ng/ml - 1.56ng/ml
灵敏度（Sensitivity）：1.5ng/ml应用（Application）：Quantification of Omalizumab in biological matrices
检测类型（Method type）：Direct sandwich ELISA
检测方法（Detection Method）：Peroxidase / OD450 
检测精度（Assay precision）：Intra-assay coefficient of variation (CV) <10%. Inter-assay CV was <10%
酶标板类型（Plate）：Strip
样本类型（Sample type）：Serum and Plasma
样本体积（Sample volume）：15ul
检测时间（Assay time）：2.5 hours
防腐剂（Preservative）：None
试剂盒组分（Components）：
Coated microtiter plate, 96 wells
Calibrator diluent. - 1.8ml
Calibrator 12ul
10X wash buffer - 25ml
Assay buffer - 50ml
1000X detection reagent - 17ul
TMB - 12ml
TMB stop solution - 12ml
Plate sealers - 3
运输条件（Shipping）：Dry ice干冰
储存（Storage）：Stable at -20℃ for 1 year

奥马珠单抗药代动力学ELISA试剂盒，Omalizumab (Xolair®) Pharmacokinetic ELISA Kit，采用双抗夹心法，可高特异性、高灵敏度地检测血清或血浆中的奥马珠单抗。

背景信息（Background information）：
Omalizumab (Xolair®) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that binds human immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma and Chronic Idiopathic Urticaria (CIU). Omalizumab inhibits the binding of IgE to IgE receptor (FcεRI) on the surface of mast cells and basophils thereby limiting the release of mediators of the allergic response from the FcεRI bearing cells.

检测原理（Summary of the assay）：
The Omalizumab ELISA kit is designed to measure free Omalizumab with high specificity and sensitivity . This assay employs the sandwich enzyme immunoassay technique. A precoated anti-Omalizumab 96 well plate is provided. Calibrator, quality control samples and test samples are pipetted into the appropriate wells. Omalizumab present in biological matrices is bound by the immobilized capture antibody. After washing away any unbound substances, enzyme linked detection antibody is added to the wells. The plate is washed to remove any unbound antibody-enzyme reagent and a substrate solution is added to the wells for color development. The color development is proportional to the amount of Omalizumab present in test samples and the concentration is calculated from the standard series.

样本采集（Sample collection）：
This kit is compatible with EDTA-plasma, heparinplasma and serum samples. Samples can be stored at or below -20°C for up to 1 year.

样本制备（Sample preparation）：
Dilute calibrators and test samples 1/50 with assay buffer (for example add 5µL of prepared calibrator or sample to 245µL of assay buffer). Mix well. Do not store diluted samples.

试剂准备（Reagent preparation）：
Prepare only the appropriate amount of required reagent on the day of use. Store all reagents as per instructions stated on the label.
1. Wash Buffer (1X) Preparation: Dilute wash buffer concentrate with ultra-pure water 1/10 before use (for example add 20mL concentrate to 180mL ultra-pure water). Mix well.
2. Detection Reagent (1X) Preparation: Dilute detection reagent with assay buffer 1/1000 before use (for example add 11μl concentrate to 11ml of assay buffer). Mix well.
3. Preparation of Calibrators: Prepare calibrators with concentrations ranging from 2,500 ng/mL to 78 ng/mL. The following is an example calibrator curve.

检测程序（Assay procedure）：
This assay employs the sandwich enzyme immunoassay technique. Anti- Omalizumab is coated onto a 96 well microplate. Calibrator and test samples are pipetted into the appropriate wells. Omalizumab present in biological matrices is bound by the immobilized anti- Omalizumab antibody. After washing away any unbound substances, enzyme linked anti- Omalizumab antibody is added to the wells. This antibody is developed and purified specifically against Xolair® (domain residing in Fc portion of the Xolair® molecule). The plate is washed to remove any unbound antibody-enzyme reagent and a substrate solution is added to the wells for color development. The color development is proportional to the amount of Omalizumab present in test samples. The color development is stopped and the intensity of the color is measured

结果计算（Results calculation）：
1. Construct a standard curve by plotting the absorbance obtained from each standard against concentration. Use a 4 or 5 parameter curve fit. Alternatively a log-log curve fit may be used.
2. The concentration of the unknowns can be read directly from this standard curve using the absorbance value for each sample.
3. Any sample undiluted or diluted still reading greater than the highest standard should be diluted appropriately with calibrator diluent and retested. If the samples have been diluted, the concentration determined from the standard curve must be multiplied by the dilution factor

[注意事项]：勃谱生物的奥马珠单抗PK ELISA试剂盒(Omalizumab PK ELISA试剂盒)产品仅用于研究用途。不可用于诊断、医疗或其他用途。
[NOTICE]: Our products are for RESEARCH USE ONLY. Not for diagnostic, medical or other use.