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ANALYTICAL PERFORMANCE SERVICES

Analytical performance evaluation is a wet lab or in silica process to assess the test’s analytical performance characteristics. 

OUR EXPERTISE IN ANALYTICAL PERFORMANCE

We offer a comprehensive suite of analytical performance studies, tailored to meet the stringent requirements of regulatory authorities and the specific needs of our clients. Our 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.

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

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

Comparator and Predicate Analysis 

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

Reproducibility and Repeatability Studies

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

Cross-Reactivity Studies 

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

ANALYTICAL PERFORMANCE

At New Day Bioresearch, we combine our expertise in analytical evaluation 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 New Day Bioresearch.