针对HBV和HCV的Alinity m定量NAT的可行性和性能评估
Sana Sajid1, Zaira Rehman1, Fouzia Naseer1
1Molecular Pathology Section, Clinical Laboratories, Indus Hospital & Health Network, Korangi Crossing, Karachi 75190, Pakistan.
概括
与罗氏Cobas 6800相比,Alinity m系统在B型肝炎病毒 (HBV) 和C型肝炎病毒 (HCV) 检测方面表现出可接受的分析性能,在较小体积的实验室中具有成本效益.
科学领域:
- 临床诊断 临床诊断 临床诊断
- 病毒学 病毒学
- 实验室自动化 实验室自动化
背景情况:
- 准确的乙型肝炎病毒 (HBV) 和乙型肝炎病毒 (HCV) 检测对于患者管理至关重要.
- 选择测试方法需要评估成本,吞吐量和性能.
研究的目的:
- 评估Alinity系统的可行性和分析性能.
- 为了比较Alinity m与Roche Cobas 6800进行HBV和HCV核酸检测 (NAT).
- 根据美国病理学家学院 (CAP) 的标准和临床和实验室标准研究所 (CLSI) 的指导方针来评估绩效.
主要方法:
- 对Alinity m和罗氏科巴斯6800的比较分析性能评估.
- 在不同的月度测试量下评估单位成本.
- 确定24小时的吞吐量能力.
- 一致性分析,报告范围的确定和精度评估.
主要成果:
- 与Cobas 6800.00相比,Alinity m显示了可接受的性能和一致性 (HBV的97.5%,HCV的87.5%).
- 与Cobas 6800相比,Alinity m的单位成本在较低的测试量 (60个测试/月) 时更有利.
- 在24小时内,Alinity m的吞吐量低于罗氏Cobas 6800.00的吞吐量.
- 两种系统都显示了可接受的内部和间距精度,没有交叉污染.
结论:
- 结合度m为HBV和HCV NAT提供了可接受的分析性能.
- 由于其成本效益,Alinity m是对具有较低吞吐量需求的实验室的合适选择.
- 这项研究支持Alinity m作为HBV和HCV检测的可行替代品.
相关概念视频
01:22Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
271
In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
271
01:25Hepatitis
86
Hepatitis is an inflammatory condition of the liver most commonly caused by hepatotropic viruses (A–E), though non-infectious causes such as alcohol and drugs also exist.Hepatitis AHepatitis A virus (HAV) is a non-enveloped RNA virus of the Picornaviridae family. It is primarily transmitted via the fecal-oral route, typically through ingestion of contaminated food or water. After ingestion, HAV enters the bloodstream through the oropharynx or intestinal epithelium and reaches the liver.
86