RealTime MTB

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。 

icon-link.png使用说明查看订购信息 
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

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

Do you wish to continue and exit this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No