心肌肌钙蛋白 I (cTnI)
PDB ID: 1J1E. Source: RCSB Protein Data Bank. For illustration purposes only.
VeriLumenTM 心肌肌钙蛋白I（cTnI）
VeriLumenTM cTnI Rapid Test is a fluorescence immunochromatographic assay intended for the quantitative measurement of cardiac troponin I (cTnI) concentration in human whole blood, plasma, or serum. Cardiac troponin I is a highly specific biomarker of myocardial injury and is widely used in the clinical assessment of patients with suspected acute myocardial infarction (AMI). The assay provides rapid and sensitive quantitative results to support timely evaluation in laboratory and point-of-care settings.
This test is mainly used as an aid in the clinical assessment and auxiliary diagnosis of myocardial infarction, supporting healthcare professionals in evaluating patients presenting with chest pain and other symptoms suggestive of acute coronary syndromes. Quantitative cTnI measurement may also assist in monitoring cardiac injury progression when interpreted together with clinical findings and other diagnostic information.
| 产品编号 | 808164 |
| 分析物 | 心肌肌钙蛋白 I (cTnI) |
| 形式 | 荧光侧向层析免疫检测（卡盒形式） |
| 诊断读数 | 定量 |
| 读取时间 | 10分钟 |
| 测量范围 | 0.05–30 ng/mL |
| 参考值 | 0.3 ng/mL | R2 | ≥ 0.95 |
| 储存条件 | 2–30°C |
| 有效期 | 18个月 |
| 证书 | CE, NMPA |
| 样本类型 | 人全血、血浆或血清 |
| 样本量 | 100μL |
| 采集方式 | 静脉血 |
| 样本稳定性 | 室温下1小时内检测稳定（经验证） |
| 可接受的抗凝剂 | EDTA / 肝素 / 枸橼酸盐（视情况而定） |
| 处理注意事项 | 样本应使用标准实验室程序进行采集和处理。尽可能使用新鲜样本，并避免使用溶血、脂血或受污染的样本。 |
| 检测方法 | 定量荧光免疫层析法 |
| 抗体形式 | 单克隆抗体 / 夹心法 |
| 信号产生 | 荧光信号（荧光标记免疫层析法） |
| 读取方式 | 仪器读取 |
| 原理 | The assay is based on a fluorescence immunochromatographic sandwich principle, in which cardiac troponin I (cTnI) present in the sample binds to specific fluorescently labeled anti-cTnI antibodies during capillary migration along the membrane. The resulting antigen–antibody complexes are captured by immobilized antibodies at the test region, and the fluorescence signal is measured and correlated with the cTnI concentration in the specimen. |
| 每盒检测次数 | 10/25/50 人份/盒 |
| 试剂盒尺寸 | 21 × 13.5 × 8 厘米 |
| 每箱盒数 | 48 盒 |
| 每箱检测次数（散装） | 1200 人份 |
| 每箱毛重（盒装） | 23.2 公斤 |
| 每箱毛重（散装） | 26.1 公斤 |
| 外箱尺寸 | 67 × 57.5 × 39 厘米 |
| 外箱体积 | 0.15 立方米 |
| 包装形式 | 独立密封检测试剂盒 / 散装配置（视情况而定） | 组件清单 | - 检测卡盒 - 干燥剂- 样本稀释液- ID芯片- 使用说明书 |
| 储存与运输条件 | 标准常温运输；按照产品标签要求储存 |
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