Overview

The development of a diagnostic assay can be a complex and time-consuming process. GenScript provides a range of products and services to overcome the barriers of new or improved assay development. We produce your high-quality materials in our state-of-the-art ISO 9001:2015 and ISO 13485 certified environments, allowing projects to easily transition from RUO-based discovery to commercialized product.

IVD Solution Introduction

In Vitro Diagnostics Workflow

Target
Identification
1
Assay Design &
Optimization
2
Assay Production &
Quality Control
3

Target Identification

Target Identification evaluates the target feasibility of whether it is possible to detect with the available technology and resources. Types of targets include proteins, antibodies, or nucleic acids. Common examples include pathogen-produced protein epitopes, cytokines, enzymes, known associated up or down-regulated proteins, or antibody response.

Assay Design & Optimization

Selecting the assay design is dependent on whether detection will be via molecular methods, antigen capture, or antibody detection. Common assay formats include ELISA, lateral flow, PCR/qPCR and cell or tissue-based assays. Assay development considerations include relevant controls, conditions, and the reagents necessary to perform the test. Once design is complete, conditions are optimized to ensure the assay is sensitive, specific, and reproducible.

Assay Production & Quality Control

The validation of a diagnostic assay adheres to the processes outlined by local regulations. In the United States, the 510(k) trial, established by the FDA, involves collecting sample data for analysis. The analysis evaluates the precision, accuracy, reportable range, reference range, analytic sensitivity, and analytic specificity of the assay.

To maintain accuracy and reliability over time, quality control procedures are implemented. These procedures may include continuous monitoring of assay performance, regular staff training, and other measures.

GenScript can offer ISO 9001:2015, ISO 13485, or GMP-grade depending on customer quality requirements.

In Vitro Diagnostic Resources

Explore our educational materials database and learn more about our technologies that support In Vitro Diagnostics development

Dr. Pei Liu
Tips for Successful ELISA kit Development

Dr. Pei Liu
Senior Scientist, GenScript

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Prof Linfa Wang
Importance and challenge of COVID-19 serology

Prof Linfa Wang
Director of the Program in Emerging Infectious Diseases of Duke-NUS Medical School, Singapore

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Reproducible and reliable research starts with high quality materials. Interested in accelerating your research with us?

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