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Pembrolizumab (Keytruda®) ELISA Kit

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SKU:
HUMB00046
€999

Description

ELISA Kit Technical Manual

Pembrolizumab (Keytruda®) ELISA Kit

Enzyme immunoassay for the quantitative determination of Pembrolizumab (Keytruda®) in serum and plasma.Enzyme immunoassay for the quantitative determination of pembrolizumab (Keytruda®) in serum and plasma. ELISA Genie pembrolizumab ELISA has been especially developed for the quantitative analysis pembrolizumab in serum and plasma samples between the Cmin and Cmax range of concentrations indicated in the pharmacokinetics section of prospectus.

Product Information

ApplicationFree drug
Required Volume (μl)10
Total Time (min)140
Sample TypeSerum, Plasma
Number of Assays96
Detection Limit (ng/mL)20 (ng/mL)
Spike Recovery (%)85-115%
Shelf Life (year)1

About Pembrolizumab (Keytruda®)

According to the prospectus; KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: -patients with unresectable or metastatic melanoma. -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. -patients with metastatic NSCLC whose tumors express PD-L1 (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. -patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing 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. - adult and pediatric patients with refractory CHL, or who have relapsed after 3 or more prior lines of therapy. 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. 1.1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. 1.2 Non-Small Cell Lung Cancer KEYTRUDA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (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. KEYTRUDA is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS?1%) as determined by an FDA-approved test, with disease progress?on 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. 4 1.3 Head and Neck Cancer KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing 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. 1.4 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. 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 (Keytruda®) ELISA Kit test principle

Solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. Standards and samples (serum or plasma) are incubated in the microtitre plate coated with the reactant specific for Pembrolizumab (Keytruda®). Following incubation wells are washed and then horse radish peroxidase (HRP) conjugate is added and binds to Pembrolizumab. After incubation, the wells are washed, and the bound enzymatic activity is detected by addition of chromogen-substrate. The colour developed is proportional to the amount of Pembrolizumab (Keytruda®) in the sample or standard. Results of samples can be determined directly using the standard curve.

Trademarks

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

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