PK ELISA Kits
Showing all 11 results
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Biosimilar PK ELISA Kits
Contact UsBiosimilar PK ELISA Kits
Biostring has developed enzyme-linked immunosorbent assays (ELISAs) for the pharmacokinetic (PK) monitoring of serum antibody levels.
The ELISA is a well established immunoassay, with clear guidelines for validation when used as a quantitative assay. However, these parameters may not always be relevant for a semi-quantitative assay used to assess whether a sample is positive or negative for a novel marker such as an antibody developed against a therapeutic antibody. We here are in the development of a quantitative PK ELISA and the different approaches of validation to prove each assay which are ‘fit for purpose.’ The parameters of linearity, accuracy, lowest level of detection, intra-assay and inter-assay variability were assessed for the quantitative PK assay. The validation outcome showed that each assay was robust, reliable and accurate to meet the requirements of the intended analytical application, that being to 1) quantitatively determine the concentration of antibody in the serum. Each assay has been successfully translated for use in a clinical trial with adequate quality controls and acceptance criteria set for monitoring consistency and performance.
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DeQuanto Adalimumab (Humira) Immunogenicity
Contact UsDeQuanto Adalimumab (Humira) Immunogenicity
Catalogue No BSPK-009 Pack Size 96 well Microtiter Plate Assay Range Refer Cut off Values Assay Format Indirect Sensitivity refer cut off values Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Adalimumab (Humira) PK ELISA Kit
Contact UsDeQuanto Adalimumab (Humira) PK ELISA Kit
Catalogue No BSPK-002 Pack Size 96 well Microtiter Plate Assay Range 5.2 – 200 ng/ml Assay Format Indirect Sensitivity 5.2 ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Bevacizumab (Avastin) PK ELISA Kit
Contact UsDeQuanto Bevacizumab (Avastin) PK ELISA Kit
Catalogue No BSPK-005 Pack Size 96 well Microtiter Plate Assay Range 0.1 – 3.1 ug/ml Assay Format Indirect Sensitivity 1.17 ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Denosumab (Xgeva) PK ELISA Kit
Contact UsDeQuanto Denosumab (Xgeva) PK ELISA Kit
Catalogue No BSPK-007 Pack Size 96 well Microtiter Plate Assay Range 1.95 – 1000 ng/ml Assay Format Indirect Sensitivity 3.91 ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Etanercept (Enbrel) PK KELISA Kit
Contact UsDeQuanto Etanercept (Enbrel) PK KELISA Kit
Catalogue No BSPK-003 Pack Size 1 x 96 well Assay Range 2.34 – 300 ng/ml Assay Format Indirect Sensitivity 2.34 ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Infliximab (Remicade) PK ELISA Kit
Contact UsDeQuanto Infliximab (Remicade) PK ELISA Kit
Catalogue No BSPK-001 Pack Size 96 well Microtiter Plate Assay Range 6.58-50 ng/ml Assay Format Indirect Sensitivity 6 ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Ranibizumab (Lucentis) Immunogenicity
Contact UsDeQuanto Ranibizumab (Lucentis) Immunogenicity
Catalogue No BSPK-10 Pack Size 96 well Microtiter Plate Assay Range Qualitative Assay Assay Format Bridge ELISA Sensitivity refer cut off values Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Ranibizumab (Lucentis) PK ELISA Kit
Contact UsDeQuanto Ranibizumab (Lucentis) PK ELISA Kit
Catalogue No BSPK-006 Pack Size 96 well Microtiter Plate Assay Range 1250 – 9.77 ng/ml Assay Format Indirect Sensitivity 4.88ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Rituximab (Mabthera) Immunogenicity
Contact UsDeQuanto Rituximab (Mabthera) Immunogenicity
Catalogue No BSPK-008 Pack Size 96 well Microtiter Plate Assay Range Qualitative Assay Assay Format Bridge ELISA Sensitivity refer cut off values Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO) -
DeQuanto Rituximab (Mabthera) PK ELISA Kit
Contact UsDeQuanto Rituximab (Mabthera) PK ELISA Kit
Catalogue No BSPK-004 Pack Size 96 well Microtiter Plate Assay Range 6.25-200 ng/ml Assay Format Indirect Sensitivity 6.25 ng/ml Accuracy & Precision Intra-Assay and Inter-Assay: CV<20% Assay Matrix Human Serum and Plasma Storage Shipped at 2-8°C. Longterm Storage at -20° C Regulatory For research use only (RUO)