Automated MycoSEQ™ Plus Assay: Common and New Approaches in Creating a Mycoplasma-Free Environment

The Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit transformed mycoplasma testing by replacing 28-day culture-based assays with a rapid, regulatory-compliant PCR method. The assay demonstrated high sensitivity, specificity and robustness for diverse biotherapeutic modalities. Thermo Fisher Scientific launched the TaqMan™-based MycoSEQ™ Plus assay in 2023 to expand coverage to at least 200 mycoplasma-related species and improve resistance to matrix interference. The Enrichment MycoSEQ™ Plus assay offers several advantages over compendial culture methods and direct PCR methods.

In this article, the results of four MycoSEQ™ Plus-based protocols are summarized, focusing on the sensitivity of the new protocols determined using live microorganisms and their applicability to regulatory requirements.