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ANALYTICAL PERFORMANCE

Analytical performance evaluation is a crucial phase in the development of diagnostics, devices, and therapeutics compliance. This wet lab or in silica process assesses the test’s analytical performance characteristics, including those listed above. For certain applications and platforms additional analytical evaluations may be necessary including determining limits of quantitation/detection, interferences, and cross-reactivities.

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.

Reproducibility and Repeatability 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 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.