GMP-manufactured qPCR components for use in clinical and molecular diagnostics
Letertre C, Perelle S, et al.
Mol Cell Probes,
For use as a component in the Purchaser's Human IVD applications only.
MGB Eclipse is a registered trademark of Elitech Group. IDT MGB Eclipse Probes are licensed for use as a component in the purchaser’s human IVD applications, and in those applications only.
We have combined our proven oligo manufacturing expertise and ISO 13485 certified production processes to deliver MGB Eclipse Probes and GMP companion primers for clinical and molecular diagnostics. Together, these probe and primer pairs are ideal for genotyping qPCR assays. Our range of fluorophore options (FAM, HEX™, TET™, and Yakima Yellow®) allows you to ensure compatibility with your instrument and more easily design multiplex assays.
Figure 1. MGB Eclipse® Probes. The incorporation of a minor groove binder (MGB) stabilizes probe-target hybridization and increases melting temperature, allowing the use of shorter probes which are better suited for allelic discrimination and targeting AT-rich regions in qPCR assays.
Among the many modifications available to you via the GMP Oligo Entry Tool, Freedom Dyes are fluorophores that have no patent licensing restrictions from IDT or any third-party company. Many common dyes are available in the portfolio, including FAM, HEX™,
JOE, MAX™, TET™, ROX™, and TAMRA. Freedom ATTO™ dyes are a particularly good substitute for VIC®, LIZ®, and Alexa Fluor® dyes due to their strong absorption and sensitivity, enhanced
photostability, and high fluorescence quantum yield. To learn more about Freedom Dyes, click here.
Assays with IDT MGB Eclipse Probes and companion primers demonstrate equivalent specificity to industry-standard assays when making genotyping calls for KRAS variants (Figure 2). End-point fluorescent signal intensities were similar or higher using MGB Eclipse Probes.
Figure 2. Equivalent results for assays with IDT MGB Eclipse® Probes and assays for Research Use Only. KRAS G12R assays comprised of MGB Eclipse Probes (FAM dye—wild-type probe; TET™ dye—mutant probe) and primers manufactured by IDT or assays for Research Use Only were used. Reactions (10 μL) were run with 104 copies of wild-type, mutant, or pooled wild-type/mutant template (gBlocks® Gene Fragments; IDT) and TaqMan® Gene Expression Master Mix (Thermo Fisher Scientific) on a CFX384 Touch™ Real-Time PCR Detection System (Bio-Rad). Cycling conditions were 3 min. 95°C; 50 x (10 sec. 95°C, 30 sec. 60°C). Amplifi cation curves for (A) wild-type and (B) mutant alleles demonstrated comparable results for MGB Eclipse Probes from IDT (left) and assays for Research Use Only (right). (C) Clear genotyping calls were made for MGB Eclipse Probes from IDT (left) and assays for Research Use Only (right).
Select qPCR primers and probe sequences for human, mouse, and rat gene expression assays
Create highly customized designs for PCR primers and qPCR assays
Select custom qPCR assays for any species
When you order GMP-manufactured oligos from IDT, you receive the highest standards of traceability. The controlled and validated process is governed by the Oligo Master Record (OMR)—our collaborative playbook for how we produce your
oligos every time you order.
When working with our GMP team, you can define and monitor all aspects of your product’s manufacture. As a GMP customer of IDT, you will have access to:
A quality GMP team should help you manage the regulatory and legal burdens that exist in the diagnostics space. Our facilities are ISO 13485:2003 certified and compliant with US FDA Quality System Regulation 21 CFR, Part 820. We maintain an “open
door” audit policy.
Our common regulatory solutions include:
You can obtain our industry-leading synthesis technologies, manufacturing capabilities, and technical expertise as a comprehensive third-party OEM service. Have custom-formulated products with your own labels and packaging shipped directly to your customers.
Our team of experts is happy to meet with you to discuss any questions or special requests you may have. Reach them anytime at GMPinfo@idtdna.com or call 800-328-2661.
Click the button below to start your process for a free consultation. If you prefer to speak with a representative, call us at 800-328-2661.