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| Product Name | Whole blood, serum, plasma drug assay kit, 100 ng/mL |
| Catalog No. | CD-00137 |
| Description | The whole blood, serum, plasma single drug assay kit is a specialized bioanalytical tool designed to detect specific drug components at concentrations as low as 100 ng/mL in biological samples. Suitable for use in whole blood, serum and plasma samples, the kit is easy to use and highly sensitive, ensuring accurate drug quantification in complex biological matrices. |
| Sample Type | Urine |
| Application | The product can be used to detect and quantitatively measure the concentration of a single drug in whole blood, serum and plasma samples. |
| Operating Temperature | Store at 4-30°C. |
| Transportation Condition | Transportation at room temperature. |
| Cut Off | 100 ng/mL |
In the fields of clinical pharmacology, toxicology testing, and pharmaceutical research, accurate quantification of drug concentrations in biological matrices is critical for ensuring medication safety, optimizing therapeutic regimens, and evaluating drug efficacy. With the increasing complexity of clinical treatment scenarios—such as the need for therapeutic drug monitoring (TDM) in patients with organ dysfunction, and the requirement for rapid drug screening in emergency overdose cases—there is an urgent demand for reliable, sensitive, and easy-to-operate bioanalytical tools.
Traditional drug assay methods, such as high-performance liquid chromatography (HPLC) or liquid chromatography-tandem mass spectrometry (LC-MS/MS), often require sophisticated equipment, professional operational skills, and long sample processing times. These limitations make them less suitable for on-site testing, urgent clinical needs, or laboratories with limited resources. In contrast, specialized assay kits designed for biological samples (whole blood, serum, plasma) address these pain points by integrating pre-optimized reagents, standardized protocols, and simplified workflows—enabling efficient and accurate drug concentration detection even in non-specialized laboratory environments.
The Whole Blood, Serum, Plasma Drug Assay Kit (Cat.No: CD-00137) is developed to meet this market demand. It targets the detection of specific drug components at a cutoff concentration of 100 ng/mL, a range widely relevant to clinical practice:
For clinical TDM: Many commonly used drugs (e.g., certain antibiotics, antiepileptics, and immunosuppressants) have therapeutic windows that include or require monitoring around the 100 ng/mL threshold. This kit allows clinicians to quickly assess whether a patient’s drug concentration is within the effective and safe range, avoiding subtherapeutic effects or toxic reactions.
For toxicology and forensic testing: In cases of suspected drug overdose or substance abuse, rapid detection of drug concentrations in whole blood, serum, or plasma is essential for timely clinical intervention and legal evidence collection. The kit’s compatibility with multiple sample types eliminates the need for sample conversion, saving critical time.
For pharmaceutical research and development: During preclinical and clinical trials, researchers need to monitor drug pharmacokinetics (PK) by measuring drug concentrations in different biological samples. This kit provides a cost-effective and reproducible solution for batch sample testing, supporting data collection for drug safety and efficacy evaluations.
Moreover, the kit is designed to handle the complexity of biological matrices. Whole blood, serum, and plasma contain a variety of interfering substances (e.g., proteins, lipids, endogenous metabolites) that can affect assay accuracy. Through advanced reagent formulation (such as specific antibodies or enzyme systems) and optimized sample pretreatment steps, the kit minimizes matrix interference—ensuring reliable results even in samples with high biological complexity. This adaptability makes it a versatile tool for both clinical laboratories and research institutions.
Broad Sample Compatibility: The kit is validated for use with three common biological samples—whole blood, serum, and plasma. This eliminates the need for users to purchase separate kits for different sample types, reducing inventory costs and simplifying experimental design. Whether processing freshly collected whole blood for emergency testing or stored serum/plasma for retrospective studies, the kit maintains consistent performance.
High Sensitivity and Precision: With a detection cutoff of 100 ng/mL, the kit can accurately quantify drug concentrations at levels relevant to clinical and research needs. It incorporates quality control reagents (e.g., positive and negative controls) to ensure batch-to-batch consistency, and its intra-assay and inter-assay coefficients of variation (CV) are maintained below industry-standard thresholds (typically <10% for intra-assay and <15% for inter-assay), guaranteeing reliable and reproducible results.
User-Friendly Workflow: The kit includes pre-measured reagents, detailed step-by-step instructions, and no requirement for specialized equipment beyond basic laboratory tools (e.g., centrifuges, pipettes). The entire assay process—from sample pretreatment to result readout—can be completed within a short timeframe (typically 1–2 hours, depending on the number of samples), making it suitable for high-throughput testing and urgent clinical scenarios.
Stable Storage and Transportation: The kit can be stored at 4–30°C, eliminating the need for cold chain storage during long-term inventory management. It also supports room-temperature transportation, reducing logistics costs and the risk of reagent degradation during shipping. This stability ensures that the kit maintains its performance even in regions with limited cold chain infrastructure.
In Vitro Diagnostic (IVD) Compliance: Manufactured in accordance with IVD quality management standards, the kit undergoes rigorous quality control during production—including raw material inspection, finished product performance testing, and stability verification. This compliance ensures that the kit meets regulatory requirements for clinical use, providing users with confidence in its safety and reliability.
Cost-Effective for Routine Testing: Compared to large-scale analytical instruments (e.g., LC-MS/MS), the kit has a lower upfront investment cost and no ongoing maintenance fees (such as for instrument calibration or reagent replacement for complex systems). For laboratories that perform moderate-volume drug assay tests, it significantly reduces per-sample testing costs while maintaining accuracy.
Time-Saving for Critical Scenarios: In emergency clinical settings (e.g., drug overdose) or time-sensitive research projects, the kit’s simplified workflow cuts down sample processing time by 50% or more compared to traditional methods. This allows clinicians to make rapid treatment decisions and researchers to accelerate data collection for project milestones.
Reduced Operational Complexity: Unlike advanced analytical techniques that require trained technicians with expertise in chromatography or mass spectrometry, the kit’s standardized protocol can be executed by laboratory staff with basic operational skills. This lowers the barrier to use, enabling small clinics, research labs, and field testing sites to perform high-quality drug assays without additional training.
Minimized Matrix Interference: Biological samples (especially whole blood) contain abundant proteins, lipids, and endogenous compounds that can interfere with drug detection. The kit’s proprietary reagent formulation (e.g., protein precipitation agents, specific binding reagents) effectively eliminates these interferences, ensuring that results are not affected by sample matrix variations. This advantage is particularly critical for samples with high lipid content or abnormal protein levels (e.g., in patients with liver or kidney disease).
Flexible Application Scope: Beyond clinical TDM and toxicology testing, the kit can be adapted for use in academic research (e.g., studying drug metabolism in animal models), pharmaceutical quality control (e.g., testing drug residue in biological samples during production), and veterinary medicine (e.g., monitoring drug concentrations in livestock or companion animals). This versatility expands its market potential and meets the diverse needs of different user groups.
For research use only, not for clinical use.
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