Nucleic acid amplification assays play a fundamental role in molecular diagnostics (MDx) testing. These nucleic acid based assays are now being run on instrument platforms known as “sample-to-answer” MDx devices. These devices are typically fast and easy to use, effectively eliminating the need for a traditional molecular laboratory core facility as discussed in the following article, Medical Laboratory Observer (MLO).
Workflow in the cartridges
Most of these “sample-to-answer” MDx devices utilize a disposable cartridge (e.g., cassette, pouch, etc.) where the biological sample is loaded and processed. The MDx device can perform the entire workflow, including: DNA purification, amplification, and detection within the cartridge. A wide range of assays are available using these disposable cartridges, including tests for influenza, sepsis, gastrointestinal distress, cancer diagnostics, etc. These assays are processed directly from the biological sample (e.g., nasal swab, blood, tissue, etc.) yielding results in less than 30 minutes to two hours.
A track record to be proud of
As the use of nucleic acid amplification tests become more commonplace, a feature critical to kit developers is the stability of the reagents embedded in the cartridge. With lyophilized reagents, the assay is stabilized and thus, may be stored at room temperature. Unfortunately glycerol, which is included as a storage buffer component in DNA polymerases and reverse transcriptases formulations, is not compatible with lyophilization.
Thermo Fisher Scientific has developed a lyo-ready enzyme format that is lyophilization compatible. The lyo-ready enzyme is formulated with glycerol content less than 0.1% and most importantly the lyo-ready enzymes retain equivalent performance to the standard enzyme format that contains glycerol. Many of the industry’s leading sample-to-answer instrument platforms utilize Thermo Fisher’s lyo-ready enzymes in their nucleic acid amplification assays and cartridges. From Platinum Taq DNA polymerase to SuperScript IV reverse transcrptase, our lyo-ready enzyme formulation delivers consistent quality and performance. The lyo-ready enzymes are manufactured under high-quality standard in accordance with ISO 13485.
For more information about lyo-ready PCR enzymes, download the flyers at thermofisher.com/lyoreadyenzymes
For Research Use Only. Not for use in diagnostic procedures.