Trastuzumab (Herceptin®)药代动力学ELISA试剂盒

抗原（Antigen）：Trastuzumab (Herceptin)
反应性（Reactivity）：Human, mouse, rat
特异性（Specificity）：Trastuzumab
检测范围（Detection range）：40ng/ml - 1.25ng/ml
灵敏度（Sensitivity）：1.25ng/ml应用（Application）：Quantification of Trastuzumab 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

曲妥珠单抗药代动力学ELISA试剂盒，Trastuzumab (Herceptin®) Pharmacokinetic ELISA Kit，专用于高特异性、高灵敏度检测曲妥珠单抗。适用血清和血浆的定量检测。

背景信息（Background information）：
Trastuzumab (Herceptin®) is indicated for the treatment of HER2-positive breast cancer, and adjuvant therapies for metastatic gastric cancer and gastroesophageal cancer. Serum concentration of Trastuzumab may predict some clinical outcome during therapy. It is also possible that the surveillance of circulating Trastuzumab concentration during therapy represents a direct factor for immunogenicity and some other side effects. Identification of biomarkers and risk factors for adverse drug reactions that might be related to serum concentrations, and maintaining the effective minimum concentration of Trastuzumab in order to potentially avoid some side effects, might be beneficial using a reliable method.

检测原理（Summary of the assay）：
The Trastuzumab ELISA kit is designed to measure free Trastuzumab with high specificity and sensitivity . This assay employs the sandwich enzyme immunoassay technique. A precoated anti-Trastuzumab 96 well plate is provided. Calibrator, quality control samples and test samples are pipetted into the appropriate wells. Trastuzumab 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 Trastuzumab 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 10mL concentrate to 90mL ultra-pure water). Mix well.
2. Detection Reagent (1X) Preparation: Dilute detection reagent with assay buffer 1/1000 before use (for example add 10μl concentrate to 10ml of assay buffer). Mix welll.
3. Preparation of Calibrators: Prepare calibrators with concentrations ranging from 1000 ng/mL to 6
2.5 ng/mL. The following is an example calibrator curve.

检测程序（Assay procedure）：
This assay employs the sandwich enzyme immunoassay technique. Anti- Trastuzumab is coated onto a 96 well microplate. Calibrator, quality control samples (if desired) and test samples are pipetted into the appropriate wells. Trastuzumab present in biological matrices is bound by the immobilized anti- Trastuzumab antibody. After washing away any unbound substances, enzyme linked antiTrastuzumab 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 Trastuzumab 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]：勃谱生物的曲妥珠单抗PK ELISA试剂盒(Trastuzumab 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.