We offer a comprehensive suite of analytical validation studies, tailored to meet the stringent requirements of regulatory authorities and the specific needs of our clients. New Day’s commitment to Quality begins with our ISO13485:2016 QMS for the design and development of in vitro diagnostics, couple to GMP/GCP/GCLP laboratory standards and CLSI guidelines for analytical testing.

Sensitivity and Specificity Analysis

Determining the test’s ability to accurately detect the presence of an analyte and to correctly exclude its absence. 

Reproducibility and Repeatablity Studies

Assessing the test’s consistency in performance across different operators, instruments, and over time.

Limit of Detection (LoD) & Limit of Quantitation (LoQ) 

Establishing the smallest amount of analyte that can be detected and quantified with reliability.

Cross-Reactivity Studies 

Evaluating the test’s specificity by testing for potential interference from substances similar to the analyte.

Comparator and predicate Analysis

Comparing the new diagnostics test against a gold standard or reference method to validate its performance. 

Analytical validation (or performance verification) is a crucial phase in the development of diagnostic tests ensuring that they accurately and reliably measure the analyte of interest in a given sample. This wet lab process assesses the test’s analytical performance characteristics, including those listed above. For certain applications and platforms additional analytical validation may be necessary including determining limits of quantitation/detection, interferences, and cross-reactivities.

By rigorously evaluating these parameters, analytical validation provides the foundation for the reliable interpretation of diagnostic measurements, ensuring they can be trusted by healthcare providers and patients alike.

When selecting a Contract Research Organization for your analytical validation studies, consider these essential factors:

EXPERTISE

Look for a team with a deep understanding of diagnostic development and validation, capable of navigating complex analytical challenges.

CUSTOMIZED SOLUTIONS

Choose a CRO that offers tailored approaches to meet you project’s specific requirements, ensuring a personalized and effective validation process.

REGULATORY PROFICIENCY

A partner knowledgeable in national and global regulatory standards and requirements is crucial for ensuring a personalized and effective validation process.

QUALITY AND INTEGRITY

Select a CRO that upholds the highest standards of quality ad conducts its studies with integrity, ensuring reliable and reproducible results.

COLLABORATIVE PARTNERSHIP

A CRO that acts as a true partner, offering transparent communication and dedicated support throughout the validation process–with YOUR strategy and end-goals in mind. 

PARTNER WITH NEW DAY DIAGNOSTICS

At New Day Diagnostics, we combine our expertise in analytical validation with a commitment to quality, collaboration and innovation. As your end-to-end partner, we are dedicated to transforming your diagnostic innovations into reality from inception to commercialization, ensuring they are ready to make a meaningful impact on healthcare and patient lives.

Discover how our analytical validation services can accelerate the development of your diagnostic solutions. Contact us today and take the next step towards realizing your diagnostic breakthrough with us.