Anti-Ipilimumab (Yervoy®)ADA Qualitative ELISA Kit

Product Type:
Biosimilar ELISA
Biosimilar ELISA Type:
Ipilimumab (Yervoy®)
Research Area:
Checkpoint Inhibitors
Frequently bought together:


Anti-Ipilimumab (Yervoy®) ADA Qualitative ELISA Kit

Enzyme immunoassay for the qualitative determination of specific antibodies to Ipilimumab (Yervoy®) in human serum and plasma. The Assay Genie Antibody to Ipilimumab (Yervoy®) ELISA Kit is intended for the qualitative determination of antibodies to Ipilimumab (Yervoy®) in serum and plasma. It is for professional use only.

Anti-Ipilimumab (Yervoy®) ADA Qualitative ELISA Kit test principle

The Assay Genie Antibody to ipilimumab (Yervoy®) ELISA is a sandwich assay for the determination of antibodies against ipilimumab in serum and plasma samples. During the first incubation period, antibodies to ipilimumab in patient serum/ plasma samples are captured by the ipilimumab (Yervoy®) 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 ipilimumab in sample.

Anti-Ipilimumab (Yervoy®) ADA Qualitative ELISA Product Information

Information Description
Free drug
Required Volume (uL)
Total Time (min)
Sample Type
Serum, Plasma
Number of Assays
Detection Limit (ng/mL)
Spike Recovery (%)
Shelf Life (year)

Alternative Names

Anti-CTLA-4 mAb


Anti-Ipilimumab (Yervoy®) ADA Qualitative ELISA - Key Information

Ipilimumab (Yervoy®) mode of action

Ipilimumab, a recombinant human monoclonal antibody (IgG1 kappa immunoglobin), is an antineoplastic agent. Ipilimumab is a fully human IgG1κ antibody that binds to CTLA-4 (cytotoxic T lymphocyte associated antigen 4), a molecule on T-cells that is indicated for unresectable or metastatic melanoma. The absence or presence of CTLA-4 can augment or suppress the immune system's T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells. The proposed mechanism of action is indirect and may be through T-cell - mediated anti-tumor immune responses.

Ipilimumab (Yervoy®) uses

Ipilimumab is indicated for the treatment of unresectable or metastatic melanoma in adults. It is also used to reduce the risk of the deadly skin cancer returning after surgery. Ipilimumab (Yervoy) shrinks tumors and contributes to patient recovery with advanced melanoma live longer. It is also approved for adjuvant therapy.

Ipilimumab (Yervoy®) pharmacokinetics and pharmacodynamics

In one pharmacokinetic study of patients with unresectable or metastatic melanoma peak concentrations, trough concentrations, and area under the curve (AUC) were found to be dose proportional in the dosage range examined (0.3, 3, or 10mg/kg every 3 weeks for four doses). The metabolism of ipilimumab does not involve the cytochrome P450 enzyme system. Because ipilimumab is a protein it is expected to be degraded into small peptides and amino acids by proteolytic enzymes. Clearance was measured to be 15.3mL/hr-16.8 mL/hr. In one pharmacokinetic study examining ipilimumab administered every 3 weeks, clearance was found to be time invariant.

Minimal systemic accumulation was observed (accumulation index of 1.5-fold or less). Steady state concentrations was reached by the third dose. Clearance will increase with increasing body weight; however, no dose adjustment is needed if administration occurs on a mg/kg basis. The following had no clinically meaningful influence on clearance: Age (range 26-86 years), gender, creatinine clearance, baseline AST, total bilirubin, ALT levels, concomitant use of budesonide, performance status, HLA-A2*0201 status, positive anti-ipilimumab antibody status, prior use of systemic anticancer therapy, baseline lactate dehydrogenase levels.

The pharmacodynamics of Ipilimumab are not completely understood. In melanoma patients receiving Ipilimumab, the mean peripheral blood absolute lymphocyte counts (ALC) increased throughout the induction dosing period. This increase occurred in a dose-dependent fashion in Phase 2 studies. Ipilimumab given with or without gp100 at 3 mg/kg increased ALC throughout the induction dosing period, but no meaningful change in ALC occurred in the control group who received an investigational peptide vaccine alone. Furthermore, ipilimumab binds to CTLA-4 with high affinity (Kd = 5.24 ± 3.62 nM). As a result, ligands CD80 and CD86 are blocked from binding to CTLA-4 with a minimum EC50 value of 0.2 μg/mL.

Ipilimumab (Yervoy®) immunogenicity

As with any biologic therapeutic, immunogenicity, in the form of anti-ipilimumab antibodies can occur. The demonstration of anti-ipilimumab antibodies during treatment with ipilimumab is a major concern. The Assay Genie Anti-Ipilimumab ADA Qualitative ELISA Kit can be efficiently used for monitoring anti-ipilimumab antibodies during therapy and offers the clinician a tool for decision on possible preventive measures such as the potential addition of an immunosuppressive drug to reduce anti-ipilimumab antibodies.

Anti-Ipilimumab (Yervoy®) ADA Qualitative ELISA Kit Contents

Size Kit Contents

1 x 12 x 8

Microtiter Plate

Break apart strips. Microtiter plate with 12 rows each of 8 wells coated with reactant

1 x 0.25 mL

Reactive Control
Ready-to-use. Contains ipilimumab-reactive reagent, human serum,
stabilizers and <0.1% NaN3

1 x 0.5 mL

Negative Control
Ready-to-use. Contains human serum, stabilizers and <0.1% NaN3

1 x 12 mL

Assay Buffer
Blue coloured. Ready to use. Contains proteins and <0.1% NaN3.

1 x 12 mL

Peroxidase Conjugate
Red coloured. Ready to use. Contains peroxidase (POD) conjugate,
stabilizer and preservatives.

1 x 12 mL

TMB Substrate Solution
Ready to use. Contains TMB

1 x 12 mL

TMB Stop Solution
Ready to use. 1N HCl

1 x 50 mL

Wash Buffer concentrate (20x)
Contains Buffer with Tween 20.

2 x 1

Adhesive Foil
For covering of Microtiter Plate during incubation.

Anti-Ipilimumab (Yervoy®) ADA Qualitative ELISA Protocol

Steps Protocol


Pipette 100µl of Assay Buffer non-exceptionally into each of the wells to be used.


Pipette 10 µL of ready-to use Negative Control, Reactive Control, and Samples into the respective wells of microtiter plate.

A1: Negative Control
B1: Negative Control
C1: Reactive Control
D1 and on: Sample (serum/plasma)


Cover the plate with adhesive film. Briefly mix contents by gently shaking the plate. Incubate 60 min at room temperature (18-25°C).


Remove adhesive foil. Discard incubation solution. Wash plate 3 times each with 300µL of diluted. Wash Buffer. Remove excess solution by tapping the inverted plate on a paper towel.


Pipette 100 µL of ready-to use Peroxidase Conjugate into each well.


Cover the plate with adhesive foil. Incubate 60 min at room temperature (18- 25°C).


Remove adhesive foil. Discard incubation solution. Wash plate 3 times each with 300 µL of diluted Wash Buffer. Remove excess solution by tapping the inverted plate on a paper towel.


Pipette 100 µL of TMB Substrate Solution into each well.


Incubate 20 min (without adhesive foil) at room temperature (18-25°C) in the dark


Stop the substrate reaction by adding 100 µL of Stop Solution into each well. Briefly mix contents by gently shaking the plate. Colour changes from blue to yellow.


Measure optical density with a photometer at 450/650 nm within 30 min after pipetting of the Stop Solution.


YERVOY is a trademark of Bristol-Myers Squibb Company.