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CD38-directed monoclonal antibody

Daratumumab Darzalex®

The SHIKARI® Daratumumab portfolio combines quantitative free-drug measurement with qualitative anti-daratumumab antibody screening for method-controlled research.

2
SHIKARI® Kits
96
Tests per kit
2
Analytical Domains
RUO
Research Use Only
Official Matriks Biotek Daratumumab product visual
TRACE & CATCH · DARATUMUMAB
Scientific Background

Why Daratumumab is relevant to biological-drug monitoring research

Daratumumab 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

Daratumumab is a human IgG1κ monoclonal antibody directed against CD38, a surface protein highly expressed on plasma cells. Source ↗

Indications

Approved Indications

EMA-authorised uses are centred on multiple myeloma across defined treatment lines and combinations, with selected use in systemic AL amyloidosis. EMA source ↗

Regulatory PK Context

IV Weekly-Phase Exposure

FDA pharmacokinetic data under approved intravenous regimens show high concentrations during the initial weekly dosing phase:

Monotherapy · end-weekly Cmin573 ± 332 µg/mL
Combination regimens · end-weekly Cmin~502–607 µg/mL

Regulatory exposure values are regimen- and population-specific and are not therapeutic targets. Values vary with dose, timing, formulation and study population. This page is for RUO product information and does not provide clinical guidance.

SHIKARI® Kit Portfolio

Two verified Daratumumab research assays

SHIKARI® Q-DAR kit, REF DAR-FD-DAR
Drug Levels Kit
SHIKARI® Q-DAR
Quantitative Analysis of Free Daratumumab (Darzalex®) ELISA
REF: DAR-FD-DAR

Ligand-binding ELISA for quantitative analysis of free daratumumab in human serum or plasma.

Representative Standard Curve
SHIKARI® Q-DAR representative standard curve for illustrative purposes only
96Tests/kit
2–8°CStorage
10–30°CShipment
Ligand-binding ELISASerum / Plasma1-year shelf life
SHIKARI® S-ATDAR kit, REF DAR-QLS-DAR
Qualitative ADA Kit
SHIKARI® S-ATDAR
Qualitative Antibodies to Daratumumab ELISA
REF: DAR-QLS-DAR

Qualitative ELISA for reactive or non-reactive assessment of anti-daratumumab antibodies using assay-specific cut-off interpretation.

96Tests/kit
2–8°CStorage
10–30°CShipment
Qualitative ADASerum / Plasma1-year shelf life
Technical Reference

Verified Specifications at a Glance

KitREFModeAnalyteSampleVolumeTimeAnalytical outputTestsShelf lifeStorageShipping
SHIKARI® Q-DARDAR-FD-DARQuantitativeFree daratumumabHuman serum / plasma10 µL100 minLOD 10 ng/mL; LOQ 10 ng/mL961 year2–8°C10–30°C
SHIKARI® S-ATDARDAR-QLS-DARQualitativeAnti-daratumumab antibodiesHuman serum / plasma20 µL140 minPositive / negative961 year2–8°C10–30°C

Analytical specifications are summarised from the current controlled IFUs and exact official product records. Standard curves are official illustrative images and must not be used for sample quantification. Follow the link on each assay card for the corresponding product record on matriksbiotek.com.

Kit Selection Guide

Match the assay to the research question

01
Quantify free daratumumab
Use DAR-FD-DAR for ligand-binding quantitative measurement of free drug.
02
Screen qualitatively for ADA
Use DAR-QLS-DAR for a positive or negative anti-daratumumab antibody result.
03
Keep analytical questions separate
Select the drug-level or ADA format according to the pre-specified research objective; the assays are not interchangeable.
Scientific Literature

Daratumumab Literature and Product-Use Records

Technical Support & Quotations

Planning a Daratumumab research study?

Matrix Biotek can help identify the appropriate Daratumumab assay and prepare regional quotation and delivery information.

Quotation Request

Review your quote list

Your quotation request is sent directly to Matrix Biotek. A confirmation copy will be sent to your institutional email. No payment is taken online. Current regional pricing, availability and delivery information will be provided in the quotation.

Technical Support