{"product_id":"rituximab-rituxan-immunogenicity-elisa-el-141-181","title":"Rituximab (Rituxan) Immunogenicity ELISA","description":"\u003ch2\u003eRituximab (Rituxan) Immunogenicity ELISA\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eAffinityImmuno Rituximab (Rituxan) Immunogenicity ELISA\u003c\/strong\u003e is a ready-to-use ELISA kit designed for pharmacokinetic (PK), anti-drug antibody (ADA), and immunogenicity workflows in biologics and biosimilar development.\u003c\/p\u003e\n\u003cp\u003eRituximab (Rituxan® ) is a chimeric mouse\/human monoclonal antibody used for treating B cell malignancy, autoimmune conditions, and graft rejection by depleting B cells from the body. This immunogenicity assay employs the bridging ELISA technique.\u003c\/p\u003e\n\u003ch3\u003eProduct Highlights\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eTarget Drug:\u003c\/strong\u003e Rituximab (Rituxan) Immunogenicity\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Type:\u003c\/strong\u003e ELISA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplication:\u003c\/strong\u003e Quantification of antibodies to Rituximab\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMethod:\u003c\/strong\u003e Bridging ELISA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDetection Method:\u003c\/strong\u003e Peroxidase \/ OD450\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReactivity:\u003c\/strong\u003e Human, mouse, rat\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDetection Range:\u003c\/strong\u003e 62.5ng\/ml - 7.8ng\/ml\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDetection Minimum:\u003c\/strong\u003e 7.8ng\/ml\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSample Type:\u003c\/strong\u003e Serum Plasma\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSample Volume:\u003c\/strong\u003e 15ul\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssay Time:\u003c\/strong\u003e 3.5 hours\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStorage:\u003c\/strong\u003e -20C, 1 year\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eShipping:\u003c\/strong\u003e dry ice, less than -20C\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePack Size:\u003c\/strong\u003e 1X96 wells\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSpecificity:\u003c\/strong\u003e Anti-Rituximab antibodies\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePlate Format:\u003c\/strong\u003e Strip\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003eKit Details\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eComponents:\u003c\/strong\u003e Coated microtiter plate, 96 wells\nQC samples - 4x50ul\n10X wash buffer - 25ml\nAssay buffer - 50ml\n1000X secondary antibody - 17ul\n1000X detection reagent - 17ul\nTMB - 12ml\nTMB stop solution - 12ml\nPlate sealers - 3\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssay Procedure:\u003c\/strong\u003e This immunogenicity assay employs the bridging ELISA technique. Capture antibody is precoated onto a 96 well microplate. Quality control and test samples are pipetted into the appropriate wells. Anti-Rituximab present in biological matrices is bound by the immobilized capture antibody. After washing away any unbound substances, secondary antibody is added to the wells and after a final wash a detection reagent is added. 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 anti-Rituximab present in test samples. Four levels of QC samples give a qualitative reference signal which can be used to determine the level of antiRituximab antibody in the unknown samples. The color development is stopped and the intensity of the color is measured.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReagent Preparation:\u003c\/strong\u003e 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 2mL concentrate to 18mL ultra-pure water). Mix well. 2. Secondary antibody (1X) Preparation: Dilute secondary antibody with assay buffer 1\/1000 before use (for examples add 12μl concentrate to 12ml of assay buffer). Mix well. 3. Detection Reagent (1X) Preparation: Dilute detection reagent with assay buffer 1\/1000 before use (for example add 12μl concentrate to 12ml of assay buffer). Mix well.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eResults Calculation:\u003c\/strong\u003e 1. Because anti-drug antibodies will vary in terms of affinity and concentration, this assay provides a qualitative readout. As such the user should use the comparable positive controls when comparing interassay results. The provided controls are tested for comparability between lots and can be traced. 2. The anti-drug antibody titers in the test samples will fall in the range of high, medium, low or negative. We recommend each lab develop their own statistical cutpoint using methodologies as described by G. Shankar, et al. (2008). (Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharmaceutical and Biomedical Analysis 48:1267–1281). 3. Any sample undiluted or diluted still reading greater than the highest standard should be diluted appropriately with assay buffer and retested. If the samples have been diluted, the concentration determined from the standard curve must be multiplied by the dilution factor.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSample Collection:\u003c\/strong\u003e 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.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSample Preparation:\u003c\/strong\u003e Dilute QC samples and test samples 1\/10 with assay buffer (for example add 30µL of prepared calibrator or sample to 270µL of assay buffer). Mix well. Do not store diluted samples. If test samples are out of range, then they may be further diluted.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssay Precision:\u003c\/strong\u003e \u0026lt;10%, \u0026lt;10%\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePreservative:\u003c\/strong\u003e None\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGene ID:\u003c\/strong\u003e 931\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSEO Keywords:\u003c\/strong\u003e Rituximab (Rituxan) Immunogenicity, Rituximab (Rituxan) Immunogenicity ELISA, AffinityImmuno, ELISA, PK assay, ADA assay, biologics analysis, immunogenicity, bioanalytical testing, pharmacokinetic ELISA\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDatasheet:\u003c\/strong\u003e \u003ca href=\"http:\/\/affinityimmuno.com\/wp-content\/uploads\/2016\/10\/EL-141-181-Rituxan-ADA-PRODUCT-SHEET.pdf\"\u003ehttp:\/\/affinityimmuno.com\/wp-content\/uploads\/2016\/10\/EL-141-181-Rituxan-ADA-PRODUCT-SHEET.pdf\u003c\/a\u003e\u003c\/p\u003e","brand":"Affinity Immuno","offers":[{"title":"Default Title","offer_id":50127972368608,"sku":"EL-141-181","price":0.0,"currency_code":"KRW","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0601\/9330\/8896\/files\/AffinityImmuno-Product-3_8892daef-3d49-4dbf-bfcd-95adb82e22e9.jpg?v=1773910669","url":"https:\/\/rndmate.com\/products\/rituximab-rituxan-immunogenicity-elisa-el-141-181","provider":"알앤디메이트","version":"1.0","type":"link"}