PD-1 Inhibitor · Fully Human IgG4 mAb · Anti-PD-1

Nivolumab Opdivo®

A fully human IgG4 monoclonal antibody targeting the programmed death-1 (PD-1) immune checkpoint receptor on T cells. By blocking PD-1 interactions with its ligands PD-L1 and PD-L2, nivolumab restores anti-tumour T cell activity. Approved across multiple oncology indications including melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma and others. The SHIKARI® nivolumab portfolio provides two free-drug quantification formats, qualitative and quantitative ADA detection and the T-CAP NAb Assay™ for neutralising antibody characterisation.

SHIKARI® Kits

Tests per kit

Analytical Domains

RUO

Research Use Only

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Footprints in snow, the official Nivolumab Trace & Catch visual — TRACE & CATCH · NIVOLUMAB

Scientific Background

Why Nivolumab is relevant to biological-drug monitoring research

Nivolumab has clinically important target biology, indication-specific dosing and measurable systemic exposure, making drug concentration and immunogenicity relevant research variables. Scientific source ↗ · EMA source ↗

Mechanism

Molecular Target & Structure

Nivolumab is a fully human IgG4 monoclonal antibody that binds PD-1 on activated T cells and blocks interaction with PD-L1 and PD-L2, reducing inhibitory signalling. Source ↗

Indications

Approved Indications

EMA-authorised uses span multiple cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head-and-neck cancer, urothelial carcinoma, selected colorectal cancers, hepatocellular carcinoma and upper gastrointestinal cancers, depending on biomarker and regimen. EMA source ↗

Published Evidence

Concentration Research Context

Regulatory pharmacokinetic analyses describe exposure under studied nivolumab regimens, while real-world research has not established a single universal therapeutic trough threshold.

Exposure–response interpretationNo universal trough target established ↗

Real-world NSCLC studyNo clear universal threshold ↗

Research-associated ranges, not universal treatment cut-offs. Values vary by endpoint, timing, assay method and population. This page is for RUO product information and does not provide clinical guidance.

SHIKARI® Kit Portfolio

Five kits. Two drug-level formats, qualitative ADA, quantitative ADA and neutralising antibodies.

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Drug Levels Kit

SHIKARI® Q-NIVO

Quantitative Determination of Nivolumab (Opdivo®) ELISA

REF: NIV-FD-OPD

Sandwich ELISA for the quantitative measurement of free nivolumab in serum and plasma. Calibrated against certified reference standards. 70-minute total assay time. Suitable for pharmacokinetic research across all nivolumab-approved oncology indications and dosing regimens.

Representative Standard Curve

96Tests/kit

2–8°CStorage

10–30°CShipment

Sandwich ELISASerum / Plasma

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Levels Specific Kit

SHIKARI® QS-NIVO

Specific and Quantitative Determination of Free Nivolumab ELISA

REF: NIV-SPEC-NIV

Quantitative sandwich ELISA using highly specific anti-idiotypic monoclonal antibodies to measure free nivolumab in serum and plasma. Requires 10 µL of sample, has a 70-minute total assay time and a 10 ng/mL detection limit. Shelf life is 6 months.

Representative Standard Curve

96Tests/kit

2–8°CStorage

10–30°CShipment

mAb-based ELISASerum / Plasma2–8°C

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Full technical datasheet on matriksbiotek.com ↗

Qualitative ADA Kit

SHIKARI® S-ATN

Qualitative Determination of Antibodies to Nivolumab ELISA

REF: NIV-QLS-OPD

Bridging ELISA for the qualitative detection of anti-nivolumab antibodies (ADA) in serum and plasma. Validated positive and negative cut-off controls included. 140-minute total assay time. Suitable for immunogenicity screening across all nivolumab oncology indications and treatment lines.

96Tests/kit

2–8°CStorage

10–30°CShipment

Bridging ELISASerum / Plasma

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Full technical datasheet on matriksbiotek.com ↗

Quantitative ADA Kit

SHIKARI® S-ATN

Quantitative Determination of Antibodies to Nivolumab ELISA

REF: NIV-QNS-OPD

Calibrated bridging ELISA for the quantitative determination of anti-nivolumab ADA titre in serum and plasma. Confirmation reagent included for drug interference assessment. 140-minute total assay time. Suitable for longitudinal ADA titre monitoring and kinetic profiling across nivolumab oncology indications.

Representative Standard Curve

96Tests/kit

2–8°CStorage

10–30°CShipment

Bridging ELISACalibrated

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Full technical datasheet on matriksbiotek.com ↗

Neutralising Ab Kit

SHIKARI® T-CAP NAb Assay™

Target Capture Neutralising Antibodies Immunoassay — Nivolumab

REF: NIV-TCAP-NAb-OPD

Target capture-based immunoassay for the detection of neutralising anti-nivolumab antibodies (NAb) in serum and plasma. Uses PD-1 target capture to identify only ADA that competitively block nivolumab's PD-1 binding site — functionally distinguishing neutralising from non-neutralising antibodies. Positive, negative, cut-off and non-neutralising antibody controls included. 140-minute total assay time.

96Tests/kit

2–8°CStorage

10–30°CShipment

Target CaptureNeutralising ADA

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Full technical datasheet on matriksbiotek.com ↗

Technical Reference

Kit Specifications at a Glance

Kit Name	Catalog Code	Type	Analyte	Format	Tests	Storage
SHIKARI® Q-NIVO	NIV-FD-OPD	Drug Levels	Free nivolumab concentration	Sandwich ELISA	96	2–8°C
SHIKARI® QS-NIVO	NIV-SPEC-NIV	Drug-Specific Levels	Specific free nivolumab concentration	mAb-based sandwich ELISA	96	2–8°C
SHIKARI® S-ATN (Qualitative)	NIV-QLS-OPD	Qualitative ADA	Qualitative anti-nivolumab ADA	Bridging ELISA	96	2–8°C
SHIKARI® S-ATN (Quantitative)	NIV-QNS-OPD	Quantitative ADA	Anti-nivolumab ADA titre	Bridging ELISA (calibrated)	96	2–8°C
SHIKARI® T-CAP NAb Assay™	NIV-TCAP-NAb-OPD	Neutralising ADA	Neutralising anti-nivolumab antibodies	Target Capture Immunoassay	96	2–8°C

Kit Selection Guide

Which kit fits your research question?

Five assay formats address nivolumab drug-level and immunogenicity research needs in oncology.

📏

I need to measure free nivolumab drug levels

Use NIV-FD-OPD for quantitative nivolumab measurement. 70-minute sandwich ELISA suitable across all approved indications and IV dosing schedules.

🧬

I need mAb-based specific free-nivolumab quantification

Use NIV-SPEC-NIV (QS-NIVO), a quantitative sandwich ELISA using highly specific anti-idiotypic monoclonal antibodies. It requires 10 µL of sample and has a 70-minute assay time.

🔍

I need to screen for anti-nivolumab antibodies

Use NIV-QLS-OPD (qualitative bridging ELISA) with validated cut-off controls. Recommended first-tier assay for immunogenicity screening in oncology cohorts.

📈

I need to quantify ADA titre longitudinally

Use NIV-QNS-OPD (calibrated bridging ELISA with confirmation reagent) for ADA titre measurement and kinetic profiling over the treatment course.

🎯

I need to characterise neutralising vs. non-neutralising ADA

Use NIV-TCAP-NAb-OPD (T-CAP NAb Assay™). PD-1 target capture detects only ADA blocking nivolumab's binding site — functionally relevant for assessing whether ADA may reduce anti-tumour efficacy by preventing PD-1 checkpoint blockade.

⚖️

I need paired drug-level and ADA data

Run NIV-FD-OPD alongside NIV-QLS-OPD or NIV-QNS-OPD. Subtherapeutic drug levels with ADA positivity indicate immunogenic failure; subtherapeutic drug without ADA may reflect non-immunogenic clearance or pharmacokinetic variability.

🔬

I need a complete nivolumab research panel

All five kits together cover two free-drug measurement formats, qualitative ADA screening, quantitative ADA titre and neutralising antibody characterisation.

Scientific Literature

Publications Using SHIKARI® Nivolumab Kits 6

2024

Csató-Kovács, Erika, et al. "Development of a Mammalian Cell Line for Stable Production of Anti-PD-1." Antibodies 13.4 (2024): 82.