膜杰作
Star Staining
产品概述（Product Details）
ClinMax™ Human PCSK9 ELISA Kit is a ready-to-use immunoassay kit, specifically designed to quantitate natural and recombinant human PCSK9 that is present in biological samples, such as human serum, plasma, and cell culture supernatants. Our ClinMax™ ELISA Kit provides several benefits:
- Standards to calibrate with NIBSC/WHO standards for comparable results.
- Fully validation in biologic samples for detection range, sensitivity, inter- and intra-plate CV, recovery, dilution linearity, specificity, and matrix effects to ensure reliable results according to ICH M10 guideline.
- High-quality antibody pairs and protein standards, along with rigorous quality control, to guarantee consistent results across different batches.
- Simplified and straightforward protocols and ready-to-use reagents to save assay time.
应用说明（Application）
The kit is developed for quantitative detection of natural and recombinant human PCSK9 in serum, plasma and cell culture supernatants.
It is for research use only.
流程图（Workflow）
关键信息（Key Features）
| Analyte | PCSK9 |
| Assay Type | Sandwich-ELISA |
| Reactivity | Human |
| Sensitivity | 0.45 ng/ml |
| Range | 0.625 ng/mL-20 ng/mL |
| Assay Time | 2.75 hr |
| Sample Type | Cell Culture Supernatants, Plasma, Serum. |
| Sample volume | 50 uL |
| Format | 96-wells plate breakable into 12 x 8 wells strips |
Elevate your research experience with our Cytokine/Biomarker Detection Kits, where accuracy, reliability, and ease of use are converging to deliver exceptional results.
存储（Storage）
Keep the unopened kit stored at 2-8 °C. Avoid using the kit beyond its expiration date. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
典型数据-Typical Data Please refer to DS document for the assay protocol.
For each experiment, a standard curve needs to be set for each microplate, and the specific OD value may vary depending on different laboratories, testers, or equipment. The following example data is for reference only. The sample concentration was calculated based on the results of the standard curve. The minimum detectable concentration of PCSK9 is less than 0.45 ng/mL.
验证（Validation）
样本值（Sample Values）
Serum – PCSK9 concentrations were measured in 24 human serum samples (dilution ratio 1:40), sample data shows in the figure below.
稀释线性（Dilution Linearity）
High concentrations of human PCSK9 serum samples were diluted with 1:2, 1:4, 1:8 and 1:16 ratios for gradient dilution to evaluate the linearity of the assay. In the serum samples, the average detection rate of PCSK9 was 100.6%.
批内差异（Intra-Assay Statistics）
Ten replicates of each of 3 samples containing different PCSK9 concentrations were tested in one assay. Acceptable criteria: CV＜10%.
批间差异（Inter-Assay Statistics）
3 samples containing different concentrations of PCSK9 were tested in independent assays. Acceptable criteria: CV<15%.
回收率（Recovery）
Recombinant PCSK9 was spiked into 3 human serum samples, and then analyzed. The average recovery of PCSK9 for serum samples is 96.4%.
组分（Materials Provided）
| ID | Components | Size |
| CEA202-C01 | Pre-coated Anti-PCSK9 Antibody Microplate | 1 plate |
| CEA202-C02 | Human PCSK9 Standard | 20 μg×2 |
| CEA202-C03 | Biotin-Anti-PCSK9 Antibody Con. Solution | 100 μL |
| CEA202-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
| CEA202-C05 | Streptavidin-HRP Con. Solution | 500 μL |
| CEA202-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
| CEA202-C07 | 20× Washing Buffer | 50 mL |
| CEA202-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA202-C09 | Substrate Solution | 12 mL |
| CEA202-C10 | Stop Solution | 6 mL |
