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Design considerations for high-throughput screening and in vitro diagnostic assays
Komandoor E Achyuthan1, David G Whitten
1Biosensors and Nanomaterials Department, Sandia National Laboratories, Albuquerque, New Mexico 87185, USA. kachyut@sandia.gov
Combinatorial Chemistry & High Throughput Screening
|September 28, 2007
Summary
This review introduces key concepts for developing robust assays for high throughput screening (HTS) and in vitro diagnostics (IVD). It covers essential statistical methods, regulatory considerations, and quality concepts for assay development professionals.
Area of Science:
- Biotechnology
- Pharmaceutical Sciences
- Clinical Diagnostics
Background:
- Assay development is critical for high throughput screening (HTS) and in vitro diagnostics (IVD).
- Established investigators and researchers require guidance on assay design and data evaluation.
- Existing literature may not cover the fundamental statistical and regulatory aspects comprehensively.
Purpose of the Study:
- To provide a tutorial on key concepts in assay development for HTS and IVD applications.
- To introduce essential terminology and statistical approaches for data evaluation.
- To guide professionals in designing robust assays and understanding regulatory requirements.
Main Methods:
- Review of fundamental assay development principles.
- Description of elementary mathematical and statistical tools for assay design and data management.
- Overview of regulatory requirements for IVDs (US FDA) and quality concepts.
Main Results:
- Key concepts for assay development are presented, applicable to both HTS and IVD.
- Statistical tools for designing robust assays and managing data are described.
- Regulatory landscape for IVDs and quality concepts are briefly outlined.
Conclusions:
- This review provides foundational knowledge for assay development professionals.
- Awareness of design considerations and statistical tools can lead to well-designed assays.
- The content serves as an introduction, guiding further investigation into specific technologies and procedures.
