• Project initiation

    01

  • Biomarker discovery

    02

  • Raw material development

    03

  • Single molecule kits development

    04

  • Kit performance assessment and validation

    05

  • Clinical transformation and application

    06
01 Project initiation
02 Biomarker discovery
03 Raw material development
04 Single molecule kits development
05 Kit performance assessment and validation
06 Clinical transformation and application
Project initiation

Key steps：

Background check, key indicator inputs

Specifics：

Development purpose
Development endpoint
Assessment indicators
Technical requirements
Outpu

Biomarker discovery

Key steps：

Proteomic assay

Specifics：

  • Marker screening

  • Sample detection

  • Data analysis

Raw material development

Key steps：

Monoclonal/polyclonal antibodies preparation

Specifics：

Antigen preparation
Antibodies preparation&assessment
Paired antibody assessment
Single molecule kits development

Key steps：

Bio-labeling, reagent optimization

Specifics：

Magnetic bead screening
Buffer system
Anti-interference system
Concentration optimization
Kit performance assessment and validation

Key steps：

Output of test results in accordance with technical requirements

Specifics：

Sensitivity
Specificity
Detection range
Anti-interference ability
Stability
Registered use output complete information

Clinical transformation and application

Key steps：

Clinical sample validation and model construction

Specifics：