ELISA Kit Development Service
Overview
At Creative Diagnostics, our ELISA kit development service specifically develops kits that enable the reliable detection and quantitation of your unique analyte. Each kit undergoes extensive assay development and validation to ensure its sensitivity and reproducibility against your desired target.
We have helped many corporations, laboratories and researchers with our custom ELISA assay development services:
- Antigen design & synthesis
- Antibody matched pair screening
- Assay development & optimization
- Complete ELISA kit manufacturing
- Precision automated microplate coating
- Translation to automated platforms
- Facilitate the transition from RUO to IVD
- Positive control antibody development
Why choose Creative Diagnostics for your ELISA kit development?
Fully Comprehensive Service
Milestones encompass antigen design & synthesis, custom antibody development & pair screening, ELISA kit optimization, validation & production
Extensive Custom Antibody Experience
Our unrivalled know-how in antibody generation from small molecule to large protein target.
Various Kit Generation
Our scientists have developed hundreds of unique diluents and have decades of experience optimizing conditions to detect analytes for various applications.
ELISA Formats
Milestones
What You Get with Our Custom ELISA Assay Development Services
- Complete assay development strategy design
- Custom assay development, from antigen preparation to sample kit delivery (Sandwich ELISA / Competitive ELISA / Other)
- Assay validation
- Delivery of all reagents
- ELISA assay transfer support
- Documentation
- Extensive quality control
- Pilot kits delivery
ELISA Kits Development: Common Areas of Application
- Drug discovery and development (PK, ADA, clinical sample screening)
- Industrial process control (HCP, antibiotics residues)
- Diagnostic biomarker assay development
- Vaccine quality control & efficiency determination
- Food, water & environmental samples analysis
- Small molecule drug monitoring
- Target expression validation on different cell lines or cell extracts
Case Studies
Anti-Peptide Drug Antibody ELISA Kit Development
Application: ADA screening
Principle: Bridging ELISA
Standard Curve:
| Parameter | Result |
| Linear range | 0 ~1000ng/ml |
| Sensitivity | 1.74 ng/ml |
| Precision | Intra assay CV<10% Inter assay CV<10% |
| Recovery/ Interference Studies | 80-120% |
| Specificity/Cross-Reactivity | Not Done |
| Matrix | Human Serum/Plasma |
Kanamycin ELISA Kit Development
Application: Impurity testing of biologic drug products
Principle: Competitive ELISA
Typical Standard Curve:
| Parameter | Result |
| Linear range | 0.5-40.5 ng/mL |
| Sensitivity | 0.5 ng/ml |
| Precision | Intra assay CV<10% Inter assay CV<10% |
| Recovery/ Interference Studies | 80-120% |
| Matrix | biological samples |
Human HPV 16 E7 Oncoprotein ELISA Kit Development
Application: Antigen detection
Principle: Sandwich ELISA
Typical Standard Curve:
| Parameter | Result |
| Linear range | 78-5000 pg/mL |
| Sensitivity | 31 pg/ml |
| Precision | Intra assay CV<10% Inter assay CV<10% |
| Recovery/ Interference Studies | 80-120% |
| Matrix | serum |