Nucleic acid formulations include DNA, RNA, siRNA, and other nucleic acid molecules that deliver highly accurate diagnostic information by identifying specific genes or pathogens through unique nucleic acid sequences. By integrating advanced technology platforms with extensive industry experience, CD Formulation is dedicated to offering high-quality nucleic acid formulation solutions for the in vitro diagnostics (IVD) sector.
In vitro diagnostics (IVD) encompass reagents, instruments, and systems utilized for the collection, preparation, and testing of samples (e.g., blood, urine, body fluids, and tissues) from the human body to identify and diagnose diseases and other medical conditions. IVDs play a crucial role in disease prevention, diagnostic assessment, treatment evaluation, therapeutic drug screening, health status assessment, and genetic prediction. Nucleic acid detection reagents are a specific category of IVDs that employ nucleic acid amplification detection technology. These reagents have been applied in various fields, including pathogen detection, early diagnosis of specific diseases, and identification of substances within the body.
Fig.1 Schematic diagram of in vitro diagnostics. (Zhang J J, et L., 2020)
Advantages of In Vitro Nucleic Acid Diagnostics
CD Formulation integrates a diverse array of expertise and services in the field of in vitro diagnostic solutions for nucleic acid formulations. We are dedicated to developing and optimizing a comprehensive range of highly efficient and accurate diagnostic tools for our clients.
We develop highly sensitive and specific real-time fluorescent quantitative PCR (qPCR) methods for the quantitative detection of nucleic acid-based drugs. This advancement contributes to the rapid detection and analysis of clinical samples, thereby enhancing diagnostic accuracy.
The introduction of efficient nucleic acid capture technologies, such as magnetic bead capture and nanomaterial-based capture methods, enables the precise isolation and detection of specific nucleic acid sequences from complex samples.
Optimization of isothermal amplification technologies for efficient nucleic acid amplification and detection, eliminating the need for complex equipment in resource-limited environments or for on-site testing.
The CRISPR/Cas system is utilized to develop a rapid in vitro nucleic acid detection program based on CRISPR technology. By leveraging the high specificity of these systems, precise identification and detection of target nucleic acid sequences can be accomplished.
Technologies | Descriptions |
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PCR Technology | It is the most widely used nucleic acid amplification technique, capable of amplifying small quantities of target DNA or RNA to detectable levels in a short period. |
qPCR Technology | Based on polymerase chain reaction (PCR), the amplification process is monitored in real time using a fluorescent dye, which enables quantitative analysis of the target nucleic acid amount. |
Nucleic Acid Amplification Tests (NAATs) Technology | Nucleic acid amplification tests (NAATs) are widely utilized in vitro diagnostic tools in modern laboratory medicine for the detection, identification, and quantification of microbial pathogens. The results of NAATs are influenced by every step of the diagnostic process, including pre-test, test, and post-test phases. Consequently, quality control of all critical aspects of the diagnostic workflow - ranging from test design and development to implementation and utilization of a NAAT for a specific microbial pathogen - is essential for obtaining accurate test results. |
Technology: IVD detection based on potential methylation biomarkers
Journal: Clinical epigenetics
IF: 4.69
Published: 2020
Results:
In this review, the authors describe methylation-based IVD assays that are currently approved for use in IVDs or are in advanced stages of development for diagnostic use. For each assay, the authors analyze the methylation detection technology used in the assay and describe the types of clinical studies that have been conducted to demonstrate the clinical validity of the assay and to obtain regulatory approval. The examples reviewed here should assist in planning clinical studies and providing the clinical evidence needed for regulatory approval of IVD assays based on potential methylation biomarkers.
Fig.2 Process of in vitro diagnostic (IVD) test development. (Taryma-Leśniak O., et al., 2020)
CD Formulation's in vitro diagnostic solutions for nucleic acid formulations encompass the entire process, from sample collection and nucleic acid extraction to testing and results analysis. Contact us for tailored services from our team of professionals, designed to meet the diverse needs of our clients and ensure superior products and services in the IVD field.
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