Diagnostic Probes Oligos Synthesis Service

Diagnostic Probes, typically fluorescently labeled oligonucleotides, are critical components in molecular diagnostics, including real-time PCR (qPCR), Digital PCR (dPCR), Fluorescence In Situ Hybridization (FISH), and microarrays. The accuracy, sensitivity, and reliability of clinical and research assays—from infectious disease testing to prenatal screening—depend entirely on the quality and precision of these synthetic probes.

CD Biosynsis offers specialized Diagnostic Probes Oligos Synthesis Service , focusing on the stringent quality control and high-efficiency labeling required for diagnostic assays. We provide synthesis and HPLC purification of a wide array of probes, including TaqMan Probes, Molecular Beacons, Scorpion Probes, and FRET-based systems . Our high-throughput platform and rigorous QC process ensure exceptional batch-to-batch consistency and validated labeling efficiency, providing reliable, clinical-grade components essential for IVD (In Vitro Diagnostics) development and high-stakes research.

Highlights

Essential capabilities for high-reliability diagnostic probe manufacturing:

• Clinical-Grade Purity: Mandatory HPLC purification (often double HPLC) and stringent QC to ensure the highest fluorophore/quencher coupling efficiency and removal of truncated sequences.
• Comprehensive Labeling: Access to a vast inventory of fluorescent dyes (e.g., FAM, HEX, CY5) and quenchers (e.g., TAMRA, BHQ series) to match all standard diagnostic platforms.
• Batch Consistency: Specialized synthesis and purification protocols guarantee minimal variation in yield and labeling efficiency between production batches, critical for LDTs (Laboratory Developed Tests) and regulatory compliance.
• Functional Validation: Optional functional testing services can be provided to verify the qPCR efficiency (R^2 and Efficiency %) of the final probe and primer set.

Applications

High-performance probes are central to sensitive and accurate molecular detection methods:

Infectious Disease Diagnostics (IVD)

           

Synthesis of highly multiplexed probes for the rapid and simultaneous detection of viral, bacterial, and fungal pathogens (e.g., COVID-19, TB).

Oncology & Liquid Biopsy

Probes designed for the highly sensitive detection of cancer-associated mutations, rare SNPs, or circulating tumor DNA (ctDNA) in patient samples.

Gene Expression Analysis & Forensics

Detection and quantification of gene transcripts, or the precise identification of genetic markers in forensic and genetic testing applications.

CRISPR-Based Detection Systems

Synthesis of specialized sgRNA and labeled reporter oligos for use in emerging nucleic acid detection platforms (e.g., SHERLOCK, DETECTR).

Products & Solutions

A specialized catalog of diagnostic probe chemistries for maximum performance and sensitivity.

TaqMan Hydrolysis Probes

Synthesis of 5' fluorophore and 3' quencher probes, purified by HPLC, ideal for standard real-time and multiplex PCR assays.

Molecular Beacons & FRET Probes

Complex hairpin structures and donor/acceptor fluorophore pairs requiring meticulous HPLC purification to ensure low background and high signal-to-noise ratio.

Minor Groove Binder (MGB) Probes

Probes with MGB modification for superior T_m stability and improved allele discrimination, crucial for SNP genotyping.

Comprehensive Dye & Quencher Set

Offering full compatibility with major qPCR instruments (e.g., ABI, Bio-Rad) using dyes like FAM, VIC, TET, CY3, CY5, and quenchers like BHQ 1, BHQ2, TAMRA.

Large-Scale & GMP-Grade Production

Capacity for high-volume, multi-batch synthesis with documentation suitable for ISO and GMP compliance for commercial diagnostic kits.

Workflow

Our dedicated workflow ensures the high purity and precision required for diagnostic applications:

• Sequence & Modification Review: Client submits the probe sequence, desired fluorophore/quencher pair, and purification level. Our team confirms compatibility and optimal labeling chemistry.
• Automated Chemical Synthesis: The oligonucleotide is synthesized on solid phase. Fluorophore and quencher molecules are introduced at the specified internal or terminal positions.
• Mandatory High-Purity Purification: Unlike standard oligos, diagnostic probes undergo mandatory HPLC purification (often sequential) to separate the fully labeled, full-length product from unlabeled or truncated side products.
• Rigorous Quality Control: QC includes Mass Spectrometry to confirm total molecular weight and the presence of both labels, UV Spectrophotometry for concentration, and analytical HPLC to confirm purity (typically >90%).
• Final Delivery & Documentation: The probe is delivered in the requested format (dry or buffer). Documentation includes a comprehensive COA, MS data, purity report (HPLC trace), and labeling efficiency data.

We provide specialized assurance for large, complex DNA projects:

• Guaranteed Functional Purity: Our stringent purification methods ensure minimal background signal, critical for the LOD (Limit of Detection) in diagnostic assays.
• High-Fidelity Labeling: We achieve high coupling efficiency for all major fluorophores and quenchers, maximizing the signal-to-noise ratio in qPCR.
• Scalable Production: Capability to scale from research-grade micrograms to clinical-grade milligram and gram quantities required for commercial kit manufacturing.
• Regulatory Support: Provision of detailed QC documentation and processes suitable for submission in IVD and LDT applications.