Bio Break: Understanding Limit of Detection and Limit of Quantification in Assay Development

Resources

Bio Break: Understanding Limit of Detection and Limit of Quantification in Assay Development

Sector: Diagnostics
Topic: Bio Break

Dive into the world of assay development with this informative episode of Bio Break, where Nick and Joris explore two critical concepts: Limit of Detection (LOD) and Limit of Quantification (LOQ). These terms might sound similar, but their implications for clinical diagnostics and medical devices are vastly different. Whether you’re an engineer, researcher, or product developer, this video sheds light on why both LOD and LOQ are vital in ensuring the precision and reliability of diagnostic tests.

Nick breaks down these acronyms, explaining how LOD refers to analytical sensitivity — essentially, how low your system can detect an analyte. Meanwhile, LOQ focuses on functional sensitivity, or how well the assay performs in real-world applications, considering variables like user handling, reagents, and diverse physiological conditions. With real-world examples, this discussion highlights the importance of understanding these thresholds to create accurate and effective diagnostic tools.

In this episode, learn about the rule of thumb engineers use to determine these limits: aiming for three standard deviations above the detection limit for LOD and a robust ten standard deviations for LOQ to ensure consistent results in practical settings. From engineering perspectives to real-world applications, Nick and Joris share insights that bridge the gap between theory and practice in assay development.

If you’re navigating the complexities of medical device or diagnostic development, this episode is a must-watch! With a focus on how engineering and functionality intersect in LOD and LOQ testing, you’ll gain actionable insights for your projects.

Key topics covered:

  • What LOD and LOQ mean for assay development.
  • Differences between analytical and functional sensitivity.
  • The importance of statistical thresholds in diagnostic reliability.

Don’t miss out—watch now to elevate your understanding of assay performance metrics!

Understanding LOD and LOQ in Assay Development

Person applying a white microneedle patch to their upper arm, with a red arrow pointing to the patch and a close-up of the microneedles on the right. Text reads “Painless!” to highlight the pain-free nature of the patch.

Nigel and Nick explore microneedle drug delivery—a growing field in medtech that aims to improve patient comfort and treatment compliance. While the term “microneedles” may sound futuristic, this technology has been around for years.

Illustration of suppository drug delivery method. Rectangular blister pack of suppositories, which are making a comeback in drug delivery, on a blue background with one suppository placed outside the packaging. Large bold text reads 'What a comeback!' with a red arrow pointing toward the suppositories, suggesting renewed interest or relevance.

Nick and Nigel discuss an often-overlooked but increasingly relevant form of drug delivery: suppositories. While typically considered old-fashioned, suppositories are experiencing a resurgence in modern MedTech thanks to their versatility, systemic absorption benefits, and emerging formulation technologies.

A gloved hand holds a syringe near the palm of another hand, which has a white grid drawn on it. The needle is poised to inject at the intersection of the lines. The background is plain white, drawing focus to the skin and procedural markings.

While most people think of Botox as a simple beauty treatment, there’s a surprising amount of engineering, anatomy, and precision behind the process.

A close-up view of a transparent smart bandage with an embedded microchip adhered to human skin. The circuit lines are visible on the bandage surface. Overlay text reads “Theranostic? Smart Bandages” with “Theranostic?” in bold purple and “Smart Bandages” in bold black, set against a soft blue and skin-toned background.

A theranostic wound dressing does more than cover a cut—it actively detects infection and delivers targeted treatment.