Diagnostics Reference Materials (Standards)
What are Molecular Diagnostics Reference Materials (Standards)?
Molecular diagnostics reference materials (standards) are rigorously quantified and stability-validated reference substances used to calibrate instruments, validate method performance, and monitor the quality of the entire experimental workflow. They ensure the accuracy, reproducibility, and cross-platform comparability of test results. Common types include positive/negative controls (to verify assay specificity), quantitative standards (to establish standard curves), and quality control materials (to monitor day-to-day stability).
Nucleic acid testing is the gold standard for pathogen molecular diagnostics, with sensitivity, specificity, and result reliability being the core requirements. However, the entire process—from sample collection to result reporting—is fraught with variables. Nucleic acid reference materials, with their known concentration and sequence, serve as the cornerstone for quality control, method validation, instrument calibration, and result traceability, making them essential for ensuring the credibility of every test report.
Currently, the market features three main categories of nucleic acid testing reference materials:
(1) Inactivated pathogens: Closest to real viruses but inherently limited by high biosafety risks, poor stability, and difficulty in precise quantification.
(2) Naked nucleic acids: Simple and low-cost to produce, but unable to mimic the physical properties of viral particles, rendering them completely incapable of monitoring the critical nucleic acid extraction step—leaving a blind spot in quality control.
(3) Armored pseudoviruses: Perfectly balance authenticity and safety, making them the ideal choice for the new generation of molecular diagnostics reference materials.
Applications of Molecular Diagnostics Reference Materials
In the field of molecular diagnostics, accuracy, reproducibility, and comparability of results are fundamental to delivering clinical and testing value. Whether monitoring infectious diseases, precisely subtyping tumors, or ensuring food safety, even a minor deviation can lead to entirely different decisions and consequences. GeneMedi provides a comprehensive portfolio of molecular diagnostics reference materials and quality control products covering infectious diseases, oncology, animal-origin component testing, and genetically modified organism (GMO) detection.
Armored Pseudovirus Particles: Nucleic Acid Reference Materials
Pseudoviruses are core reference materials and quality controls for infectious disease molecular diagnostics (e.g., qPCR, RT-qPCR, dPCR, isothermal amplification). They structurally mimic authentic viruses (including envelope proteins) while encapsulating non-infectious recombinant RNA or DNA genomes. These genomes contain the specific target sequences of interest.
Pseudoviruses are viral particles that contain the exact target sequences and are enveloped in authentic viral shells, perfectly simulating real viruses. Sequences must include customer-specified targets. Technical challenges include the limited packaging capacity of lentiviral systems (~4 kb); these are often overcome by constructing high-frequency target gene pseudoviruses to cover common subtypes.
Oncology Reference Materials
Tumor molecular diagnostics has entered the era of precision medicine, relying on accurate detection of specific gene mutations, fusions, MSI, TMB, and other biomarkers. GeneMedi’s oncology reference materials are prepared by introducing genomic DNA from tumor cell lines harboring specific mutations or synthetically designed gene fragments into designated background cell lines or simulated plasma matrices, thereby mimicking real tumor patient samples (e.g., tissue sections, ctDNA).
Animal-Origin Detection Reference Materials
In food authenticity and species identification, molecular diagnostics (e.g., species-specific PCR, real-time fluorescent PCR) represent the gold standard for detecting meat adulteration and confirming species composition. GeneMedi’s animal-origin reference materials provide precisely identified genomic DNA from single species or multi-species mixtures, serving as positive controls for assay development and validation.
Genetically Modified Organism (GMO) Detection Reference Materials
Most countries and regions worldwide have established mandatory labeling thresholds for GMO ingredients in food. qPCR-based GMO detection is the mainstream technology. GeneMedi offers plasmid DNA or genomic DNA reference materials containing common exogenous genes and species-specific endogenous reference genes from major transgenic crops (e.g., soybean, maize, canola, cotton).
Infectious Disease Detection: Pseudotyped Virus
What is a Pseudotyped Virus?
A pseudotyped virus is a genetically engineered recombinant viral particle. It retains the capsid and envelope structure of an authentic virus but encapsulates a replication-incompetent recombinant genome carrying specific target sequences. Through genomic modification, it can participate in the entire virus detection workflow—from nucleic acid extraction to amplification. It offers biosafety while serving as a measurement standard, and is used for the validation and evaluation of qualitative and quantitative viral nucleic acid detection methods as well as laboratory quality control.
GeneMedi is a trusted third-party provider of quality control materials in the field of infectious disease molecular diagnostics. Consistent use of GeneMedi’s molecular quality control products helps monitor assay performance, providing greater confidence in the quality and reliability of clinical laboratory testing and diagnostic reagent development. Pseudotyped viruses play a critical role in infectious disease detection, particularly for high-risk pathogens such as SARS-CoV-2 and Ebola virus, as they eliminate the biosafety hazards associated with handling live viruses while preserving the key characteristics required for viral entry into host cells.
Product Features
Flexible Nucleic Acid and Host Classification: Available in both DNA and RNA types; customizable for Human or Animal hosts; covers multiple species receptors to meet diverse research needs.
High Titer and Efficiency: High infection rate, supports high-throughput screening, and saves experimental time.
Excellent Authenticity: Surface expression of key viral proteins essential for cell entry, accurately simulating authentic viral infection mechanisms.
Superior Safety: Capable of only single-round infection, no autonomous replication capability, non-pathogenic; compatible with Biosafety Level 2 (BSL-2) laboratories, significantly reducing laboratory risks.
Comprehensive Validation: Validated across multiple sample types (serum, neutralizing antibodies) with high concordance to live-virus results.
Outstanding Stability: Reliable quality control methods, excellent batch-to-batch consistency, enabling long-term stable production and supply.
Applications of Pseudotyped Viruses
(1) Diagnostic Kit Development: Serves as an ideal internal control in kits, effectively eliminating false negatives.
(2) Viral Entry Mechanism Research: Studies interactions between viral envelope proteins and host cell receptors.
(3) Vaccine Immunogenicity Evaluation: Assesses humoral immune responses elicited by candidate vaccines, including the level and persistence of neutralizing antibodies.
(4) Antiviral Drug Screening: Screens small-molecule drugs or neutralizing antibodies capable of blocking viral entry.
(5) Serological Testing: Detects virus-neutralizing antibodies in clinical samples and supports epidemiological investigations.
(6) Epidemiological Surveillance: RNA pseudoviruses are used for variant characterization, serving as key evaluation tools in COVID-19 detection, vaccine development, and antiviral drug research.
(7) Gene Therapy Vector Development: Optimizes targeting and transduction efficiency of gene therapy vectors by using envelope proteins from different viruses.
Product List
Designed according to nucleic acid classification (DNA/RNA) and host type (Human/Animal), GeneMedi provides standardized, high-purity pseudotyped viral particles as reference materials and quality control products for infectious disease molecular diagnostics.
