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.
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
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.
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
effects, it is important the quality of the product is verified prior to distribution. For manufactured heparin, it is vital that the activity of the heparin-antithrombin complex
to a particular pentasaccharide region that consists of sulfated glucosamine residues not commonly found elsewhere in the compound. This pentasaccharide region will bind with antithrombin, a protein in the blood stream which functions as a naturally occurring mild blood thinner.⁵ The resulting heparin-antithrombin complex inhibits serin
The presence of this moiety in the produced drug has been linked to allergic reactions. Adverse effects like this highlight the need to thoroughly test the quality of drug products prior to distribution.
For manufactured heparin, it is vital that the activity of the heparin-antithrombin complex meets designated standards to ensure the quality of the final product.
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.
Unfortunately glycerol, which is included as a storage buffer component in DNA polymerases and reverse transcriptases formulations, is not compatible with lyophilization.
