Romiplostim ELISA Kit

Sample

Serum, plasma

Species Reactivity

Human

Detection Method

sELISA

Intended Use

Romiplostim ELISA Kit is an enzyme immunoassay developed for detection and quantitation of the Romiplostim from plasma and serum.

Contents of Kit

1. Coated Plate: One strip well 96-well plate. -20°C
2. Biotinylated Antibody (100X): One 120 μL vial. -20°C
3. Streptavidin-Enzyme Conjugate (100X): One 120 μL vial. -20°C
4. Romiplostim Standard (500 pg): Two bottles. -20°C
5. Assay Diluent: One 50 mL bottle. 2-8°C
6. 20× Wash Buffer: One 50 mL bottle. 2-8°C
7. Substrate Solution: Two 6 mL bottles. 2-8°C
8. Stop Solution: One 7 mL bottle. 2-8°C

Storage

Upon receipt, store components according to the label: keep the Coated microplate, Romiplostim standard, Biotinylated Antibody (100×), and Streptavidin-Enzyme Conjugate (100×) sealed at -20°C. Store the remaining reagents at 2–8 °C, and keep plate sealers at room temperature. Avoid repeated freeze–thaw cycles (especially standards and detection reagents), and equilibrate required components to room temperature before use; use the kit within its expiration date.

Precision

Precision was assessed by testing samples at multiple concentration levels in replicates within a single run (intra-assay) and across independent runs (inter-assay). The resulting intra-assay and inter-assay CV% values were all <10%.

Detection Range

0-1000pg/mL

Sensitivity

The assay sensitivity (LoD) is 11.2 pg/mL, calculated as Mean + 2 SD of the zero standard signal and interpolated from the standard curve. Samples with concentrations below the LoD may not be reliably distinguished from background.

General Description

Romiplostim (Nplate®) is a thrombopoietin receptor agonist widely used for the treatment of immune thrombocytopenia (ITP) by stimulating platelet production. Due to substantial inter-individual pharmacokinetic variability and the clinical need to optimize dosing, accurate measurement of circulating romiplostim levels is important for PK studies, exposure–response evaluation and supporting individualized therapy.Using Romiplostim -specific antibodies as both coating and capture reagents, we have developed a highly sensitive ELISA kit for quantifying Romiplostim.

Standard Curve

The following figures demonstrate typical Romiplostim ELISA results. One should use the data below for reference only. This data should not be used to interpret actual results.