MinGin Kim

Recent updates to Ph. Eur. 2.6.7 and USP <77> place greater emphasis on full-workflow validation, control strategies, sensitivity justification, and fit-for-purpose implementation of nucleic acid testing (NAT) methods. The focus is shifting from simple method comparison toward demonstrating reliable, reproducible performance across the entire mycoplasma testing workflow. Pharmacopeial Mycoplasma testing expectations haven’t suddenly changed overnight—but they have shifted in meaningful ways.

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You are already at the latest version Low-density DNA microarrays are pivotal in molecular diagnostics due to their cost-effectiveness, high sensitivity, and ease of use. However, reliable spot localization remains a challenge, primarily due to variations in spot positions resulting from printing and alignment inaccuracies, as well as the presence of image artifacts. Traditional intensity-based methods are often inadequate, particularly when target spots exhibit weak fluorescence signals.