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Anti-Pembrolizumab (Keytruda®) ADA Qualitative ELISA Kit

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ELISA Kit Technical Manual

Anti-Pembrolizumab (Keytruda®) ADA Qualitative ELISA Kit

Enzyme immunoassay for the qualitative determination (screening) of antibodies to Pembrolizumab (Keytruda®) in serum and plasmaThe ELISA Genie Antibody to Pembrolizumab (Keytruda®) Enzyme-Linked ImmunoSorbent Assay (ELISA) Kit is intended for the qualitative determination of antibodies to pembrolizumab (Keytruda®) in serum and plasma. It is for professional use only.

Product Information

ApplicationFree drug
Required Volume (μl)10
Total Time (min)140
Sample TypeSerum, Plasma
Number of Assays96
Detection Limit (ng/mL)plus/minus
Spike Recovery (%)-
Shelf Life (year)1

About Anti-Pembrolizumab (Keytruda®) ADA Qualitative

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PDL1 and PD-L2. It is used for the treatment of several types of cancer such as, Melanoma, Non-Small Cell Lung Cancer and Head and Neck Cancer. Due to its success in clinical trials, pembrolizumab was approved early to allow quick patient access and was given breakthrough therapy and orphan drug designation. Pembrolizumab (as Keytruda) was approved by the U.S. Food and Drug Administration to treat advanced cases of the most common type of lung malignancy, non-small cell lung cancer on Oct. 2, 2015. Keytruda was additionally approved for the treatment of Classical Hodgkin Lymphoma (cHL) in March 2017 Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of the patients with unresectable or metastatic melanoma. The patients with metastatic NSCLC whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) ?50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC. The patients with metastatic NSCLC whose tumors express PDL1 (TPS ?1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. The patients with recurrent or metastatic HNSCC with disease progression on or after platinumcontaining chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Pembrolizumab is an antibody drug that targets the cell surface receptor programmed cell death protein 1 (PD-1) found on T cells. By preventing the binding of its ligands (PD-L1 and PD-L2), pembrolizumab induces an antitumor immune response. Upregulation of PD-1 ligands is a mechanism for tumours to evade antitumor immune response; when PD-1 binds its ligand, the T cell receives an inhibitory signal leading to T cell energy and blockade of anti-tumour immune response. Instead of directly targeting tumor tissue to induce tumor cell death, pembrolizumab acts as a checkpoint inhibitor to stimulate immune responses to eliminate cancer cells. Steady-state concentrations of pembrolizumab were reached by 19 weeks of repeated dosing with an every 3- week regimen and the systemic accumulation was 2.2-fold. The peak concentration (Cmax), trough concentration (Cmin), and area under the plasma concentration versus time curve at steady state (AUCss) of pembrolizumab increased dose proportionally in the dose range of 2 to 10 mg/kg every 3 weeks.

Anti-Pembrolizumab (Keytruda®) ADA Qualitative ELISA Kit test principle

The Elisa Genie Antibody to pembrolizumab (Keytruda®) ELISA is a sandwich assay for the determination of antibodies against pembrolizumab in serum and plasma samples. During the first incubation period, antibodies to pembrolizumab (ATP) in patient serum/ plasma samples are captured by the drug pembrolizumab (Keytruda®) coated on the wall of the microtiter wells. After washing away the unbound components from samples, a peroxidase-labelled specific conjugate is added to each well and then incubated. After a second washing step, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of ATP in sample.


Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

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