Eculizumab Soliris®
The SHIKARI® Eculizumab portfolio provides quantitative free-drug measurement, quantitative and qualitative anti-drug-antibody assays, and a target-capture neutralising-antibody assay for human serum or plasma.
Why Eculizumab is relevant to biological-drug monitoring research
Eculizumab has clinically important target biology, indication-specific dosing and measurable systemic exposure, making drug concentration and immunogenicity relevant research variables. Scientific source ↗ · EMA source ↗
Molecular Target & Structure
Eculizumab is a humanised monoclonal antibody that binds complement protein C5 and prevents cleavage to C5a and C5b, inhibiting terminal complement activation. Source ↗
Approved Indications
EMA-authorised uses include paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), refractory AChR-antibody-positive generalised myasthenia gravis and AQP4-antibody-positive neuromyelitis optica spectrum disorder in defined patients. EMA source ↗
Indication-Specific Maintenance Exposure
FDA pharmacokinetic data demonstrate substantial indication- and regimen-dependent exposure:
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.
Four verified Eculizumab research assays
Monoclonal-antibody-based ELISA for quantitative measurement of free eculizumab in human serum or plasma.
Quantitative ELISA for antibodies to eculizumab in human serum or plasma, including the assay-specific confirmation-reagent procedure.
Qualitative ELISA for positive or negative assessment of antibodies to eculizumab in human serum or plasma according to assay-specific cut-off interpretation.
Target-capture immunoassay for qualitative detection of free neutralising antibodies to eculizumab in human serum or plasma.
Verified Specifications at a Glance
| Kit | REF | Mode | Analyte | Sample | Volume | Time | Analytical output | Tests | Shelf life | Storage | Shipping |
|---|---|---|---|---|---|---|---|---|---|---|---|
| SHIKARI® QS-ECU | ECU-SPEC-ECU | Quantitative | Free eculizumab | Human serum / plasma | 10 µL | 70 min | LOD 15 ng/mL; LOQ 20 ng/mL | 96 | 1 year | 2–8°C | 10–30°C |
| SHIKARI® S-ATEC | ECU-QNS-SOL | Quantitative | Antibodies to eculizumab | Human serum / plasma | 5 µL | 140 min | LOD 6.25 ng/mL; LOQ 20 ng/mL | 96 | 1 year | 2–8°C | 10–30°C |
| SHIKARI® S-ATEC | ECU-QLS-SOL | Qualitative | Antibodies to eculizumab | Human serum / plasma | 20 µL | 140 min | Positive / negative | 96 | 1 year | 2–8°C | 10–30°C |
| SHIKARI® T-CAP NAb™ — Eculizumab | ECU-TCAP-NAb-SOL | Qualitative | Free neutralising antibodies to eculizumab | Human serum / plasma | 5.2 µL | 170 min | LOD 50 ng/mL; qualitative | 96 | 6 months | 2–8°C | 10–30°C |
Analytical specifications are summarised from the current controlled IFUs and exact official product records. Standard curves are official illustrative product images and must not be used for sample quantification. Follow the link on each assay card for the corresponding product record on matriksbiotek.com.
Match the assay to the research question
Choose among the four assays according to the analytical output required by the study.
Eculizumab Literature and Product-Use Records
Planning a Eculizumab research study?
Matrix Biotek can help identify the appropriate Eculizumab assay and prepare regional quotation and delivery information. SHIKARI® products are developed and manufactured in Ankara and supported through our European headquarters in Barcelona.