MGB Eclipse probes and companion primers are manufactured under GMP conditions, which allows you to:
We have combined our proven oligo manufacturing expertise and ISO 13485 certified production processes to deliver GMP-manufactured MGB Eclipse Probes and companion primers. Together, these probe and primer pairs are ideal for genotyping qPCR assays. Our range of fluorophore options (FAM, HEX, TET, and Yakima Yellow® (EliTech Group)) allows you to ensure compatibility with your instrument and more easily design multiplex 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™ (Atto-Tec GmbH) dyes are a particularly good substitute for VIC® (ThermoFisher Scientific), LIZ® (ThermoFisher Scientific), and Alexa Fluor® (ThermoFisher Scientific) dyes due to their strong absorption and sensitivity, enhanced photostability, and high fluorescence quantum yield. To learn more about Freedom Dyes, click here.
In the United States, MGB probes are not limited to human in vitro diagnostic use only. Although a number of other available applications exist, including in vitro diagnostics, commercial, agricultural biotechnology (agbio), and research, each customer who purchases this product is required to obtain their own regulatory approval for any use outside of research. In other jurisdictions, MGB Eclipse Probes are licensed by ELITech for use solely in human in vitro diagnostic end-use applications. Customers need to follow the licensing requirements of their specific jurisdiction. IDT manufactures MGB Eclipse probes and companion primers under GMP conditions and using ISO certified processes.
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). Amplification 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).
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 using the IDT Help Request Form or call 800-328-2661.