Molecular
Molecular

RealTime MTB

大型产品缩略图
m2000 RealTime 系统

CE 标志

供体外诊断使用

Abbott RealTime MTB 测定是一种体外聚合酶链反应 (PCR) 测定法，用于定性检测痰或支气管肺泡灌洗液涂片阳性或涂片阴性标本中的 MTB 复合体 DNA，以及从疑似结核患者的痰和支气管肺泡灌洗液中制备的 N-乙酰-L-半胱氨酸 (NALC) 制备的沉淀物。 

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描述
 

领先科技

  • 即使在涂片阴性、培养物阳性样本中也具有高灵敏度和特异性，能够可靠检测 MTB 复合体的八个成员
  • 灭活试剂将样本处理过程中的感染风险降至最低

本测定旨在与临床表现和其他实验室标志物配合使用，用于辅助诊断 TB 感染。mPLUS 扩展了试剂使用的可用性。

Abbott RealTime MTB 测定的性能特征是通过检测预期和已获得的样本（痰、NALC 沉淀物）来确定的，所述样本均从美国和非美国人群中具有症状提示为活动性 TB 的受试者中采集。根据需要对每个样本进行分类，以使用显微镜涂片、培养和 Abbott RealTime MTB 进行检测。在采集的研究中心或其附近进行显微镜涂片检查和/或培养。将 Abbott RealTime MTB 的检测结果与培养状态进行比较，以计算测定灵敏度和特异性。结果还按抗酸杆菌 (AFB) 涂片状态分层，以获得额外的敏感性状态。

设计
 

开发理念

Abbott RealTime MTB 测定旨在解决 MTB 检测挑战。

基于 Abbott Molecular RealTime 传承开发的测定设计。

  • 可靠检测 MTB 复合体的八个成员
  • 即使在涂片阴性、培养物阳性样本中也具有高灵敏度和特异性
  • 双靶标测定设计

从提取到扩增和检测的自动化工作流程。

  • 涵盖低容量到高容量检测的灵活通量范围
  • 灭活试剂将样本处理过程中的感染风险降至最低 

致力于减轻传染病负担。

规格
 
 
 
Abbott RealTime MTB
敏感性培养物阳性样本 93%
涂片阴性培养物阳性标本的敏感性 81%
特异性 97%
检测限 (LoD) 17 CFU/mL
靶标区域 IS 6110 和 PAB
报告结果 检测到 MTB，未检测到 MTB
亚种 MTB 复合体的八个成员：
M. tuberculosis（结核分枝杆菌）、M. africanum（非洲分枝杆菌）、M. bovis（牛型分枝杆菌）、M. bovis BCG（牛型分枝杆菌 BCG）、M. microti（田鼠分枝杆菌）、M. caprae（羊型分枝杆菌）、M/ pinnipedii（海豹分枝杆菌）、M. canetti（卡氏分枝杆菌）
内部对照品 继续处理每份样本
样本类型 痰或支气管肺泡灌洗液、或痰或支气管肺泡灌洗的 NALC 沉淀物
输入容量 0.8 mL 灭活样品
样品制备 m2000sp 或手动

订购信息

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