TaqPath 1-Step RT-qPCR Master Mix, CG, is designed for robust and reproducible one-step pathogen detection and gene expression workflows. The single-tube 4X formulation contains thermostable MMLV reverse transcriptase, dNTPs, UNG, ROX dye, and thermostable Fast DNA polymerase, facilitating easy reaction set up—just add user-supplied assay and sample (Figure 1). All manufacturing lots are functionally tested to ensure remarkable lot-to-lot reproducibility for CT consistency and dynamic range across a wide variety of assays. TaqPath 1-Step RT-qPCR Master Mix, CG, is a General Purpose Reagent (GPR) is labeled ‘For Laboratory Use’ and, manufactured in an ISO 13485-certified and FDA-registered facility that adheres to cGMP principles. With stringent quality coupled with premier performance, TaqPath 1-Step RT-qPCR Master Mix, CG, is a superior choice for your diagnostic or biopharmaceutical testing and development needs.
Features of the TaqPath 1-Step RT-qPCR Master Mix, CG, include:
• High sensitivity to detect low-copy targets with reproducible CT results
• 6 logs of dynamic range with RNA, DNA, and multiplexing applications
• Tolerance of inhibitors commonly found in clinical and biopharma samples
• Advanced manufacturing production and process controls ensure lot-to-lot consistency
• Compliance Package containing most frequently requested compliance documents, available below, commonly used to comply with internal quality systems and regulatory requirements in molecular diagnostic assay and drug development
With understanding of the importance of reproducible detection for low-titer pathogen or transcripts in clinical diagnostic testing, bioprocess QC testing, and adventitious testing, TaqPath 1-Step RT-qPCR Master Mix, CG, has been optimized as a higher-concentration 4X master mix that allows you to input more sample into each reaction, increasing sensitivity even in low-volume reactions. Figure 2 shows consistent CT results obtained from three unique lots when detecting 10 copy inputs of RNA target. Figure 3 demonstrates CT lot-to-lot consistency is preserved across multiple assays with different attributes and expression levels.
Wide Dynamic Range Compatible with RNA, DNA, and Multiplexing
TaqPath 1-Step RT-qPCR Master Mix, CG, has been optimized to provide high specificity and dynamic range for use with both RNA and DNA targets. Since virology labs often test for both RNA and DNA viruses, TaqPath 1-Step RT-qPCR Master Mix, CG, is designed to use a single protocol to assay both types of nucleic acid. This input flexibility can help streamline the number of different workflows in your lab to improve efficiency. Figure 4 demonstrates the excellent PCR linearity across a 6-log input range for both RNA (Figure 4a) and DNA targets (Figure 4b).
TaqPath 1-Step RT-qPCR Master, CG, is compatible with multiplexing reactions, allowing for additional exogenous or endogenous controls or targets to be run simultaneously for quality control or efficiency purposes. Figure 5 demonstrates TaqPath 1-Step RT-qPCR Master Mix performance in a triplex reaction. The formulation can be run in either fast or standard cycling conditions with equivalent performance across a wide variety of qPCR platforms.
TaqPath 1-Step RT-qPCR Master Mix, CG, has been benchmarked against similar competitor master mixes and demonstrates equivalent or better sensitivity and dynamic range across a variety of targets (Figure 6).
Unlike other master mixes on the market, TaqPath 1-Step RT-qPCR Master Mix’s unique proprietary formulation allows robust performance even in the presence of PCR inhibitors typically found in biopharmaceutical, molecular diagnostics, and research applications. Optimized performance in the presence of such substances that can normally inhibit PCR, such as heparin, hematin, or EDTA, helps increase confidence when working with a variety of complex clinical or biopharma samples. TaqPath master mixes demonstrate increased tolerance of inhibitors compared to competitor mixes (Figure 7).
Manufacturing Production and Process Controls
TaqPath qPCR Master Mix is manufactured under a strong quality management system that utilizes traceable quality raw materials and validated operating procedures. With established controls from purchasing through QC release, TaqPath product manufacturing is designed to produce consistent product performance lot after lot. The stringent QC is important for a variety of applications, making the master mix ideal for bioprocess quality control testing, biologics adventitious testing, molecular diagnostics, and research applications.
General Purpose Reagent manufactured under cGMP
TaqPath master mixes are general purpose reagents labeled 'For Laboratory Use' and manufactured in an ISO 13485-certified and FDA-registered facility that adheres to cGMP principles.
In an effort to efficiently support your compliance needs, frequently requested compliance documents are available here:
• Statement of Quality relating to the current good manufacturing practices (cGMP) to which TaqPath master mixes adhere
• Detailed lot-specific Certificate of Analysis (COA) (see below in Documents & Downloads section)
• Product Stability Statement
• Supplier Evaluation Support
-- Completed Self Assessment
-- ISO certificates by manufacturing site
• For EU Reach compliance-related inquiries, email 'LSGChemicalCompliance@thermofisher.com'
• BSE/TSE Statement
• Change Control and Notification Registration
Not finding the compliance document you’re looking for? Technical Support is here to help.