Trastuzumab Herceptin®
The SHIKARI® Trastuzumab portfolio provides two quantitative free-drug formats, quantitative and qualitative anti-trastuzumab antibody assays, and a target-capture neutralising-antibody assay.
Why Trastuzumab is relevant to biological-drug monitoring research
Trastuzumab 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
Trastuzumab is a humanised IgG1 monoclonal antibody that binds subdomain IV of the extracellular region of HER2 and inhibits HER2-driven signalling while supporting Fc-mediated effector activity. Source ↗
Approved Indications
EMA-authorised uses include HER2-positive early and metastatic breast cancer and HER2-positive metastatic gastric or gastro-oesophageal-junction adenocarcinoma in defined treatment settings. EMA source ↗
IV Q3W Steady-State Exposure
FDA pharmacokinetic data for the 8 mg/kg loading then 6 mg/kg every-three-weeks breast-cancer regimen report:
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.
Five verified Trastuzumab research assays
Ligand-binding ELISA for quantitative analysis of free trastuzumab in human serum or plasma.
Monoclonal anti-idiotypic, mAb-based ELISA for specific quantitative determination of free trastuzumab in human serum or plasma.
Quantitative ELISA for anti-trastuzumab antibodies in human serum or plasma, including the assay-specific confirmation-reagent procedure.
Qualitative ELISA for positive or negative assessment of anti-trastuzumab antibodies in human serum or plasma according to assay-specific cut-off interpretation.
Target-capture immunoassay for qualitative detection of free neutralising antibodies to trastuzumab, using positive, negative, cut-off and non-neutralising-antibody controls.
Verified Specifications at a Glance
| Kit | REF | Mode | Analyte | Sample | Volume | Time | Analytical output | Tests | Shelf life | Storage | Shipping |
|---|---|---|---|---|---|---|---|---|---|---|---|
| SHIKARI® Q-TRAS | TRA-FD-HH | Quantitative | Free trastuzumab | Human serum / plasma | 10 µL | 70 min | LOD 3 ng/mL; LOQ 10 ng/mL | 96 | 1 year | 2–8°C | 10–30°C |
| SHIKARI® QS-TRAS | TRA-SPEC-TRA | Quantitative | Free trastuzumab | Human serum / plasma | 10 µL | 70 min | LOD 3 ng/mL; LOQ 3 ng/mL | 96 | 6 months | 2–8°C | 10–30°C |
| SHIKARI® S-ATT | TRA-QNS-HH | Quantitative | Anti-trastuzumab antibodies | Human serum / plasma | 20 µL | 140 min | LOD 7.5 ng/mL; LOQ 10 ng/mL | 96 | 1 year | 2–8°C | 10–30°C |
| SHIKARI® S-ATT | TRA-QLS-HH | Qualitative | Anti-trastuzumab antibodies | Human serum / plasma | 20 µL | 140 min | Positive / negative | 96 | 1 year | 2–8°C | 10–30°C |
| SHIKARI® T-CAP NAb™ — Trastuzumab | TRA-TCAP-NAb-HH | Qualitative | Free neutralising antibodies to trastuzumab | Human serum / plasma | 10 µL | 140 min | LOD 20 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
Publications Using SHIKARI® Trastuzumab Kits 12
All journal publications below are drawn from the Matrix Biotek Publications library and are shown newest first. Records are included when the publication database identifies the biological drug and SHIKARI® product use.
Planning a Trastuzumab research study?
Matrix Biotek can help identify the appropriate Trastuzumab assay and prepare regional quotation and delivery information.