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印度南部一家三级艾滋病护理中心即时检测Xpert HIV-1血浆病毒载量检测法的性能

Performance of point-of-care Xpert HIV-1 plasma viral load assay at a tertiary HIV care centre in Southern India.

作者信息

Swathirajan Chinnambedu Ravichandran, Vignesh Ramachandran, Boobalan Jayaseelan, Solomon Sunil Suhas, Saravanan Shanmugam, Balakrishnan Pachamuthu

机构信息

Y. R. Gaitonde Centre for AIDS Research and Education, Taramani, Chennai 600113, India.

Laboratory-based Department, UniKL-Royal College of Medicine Perak (UniKL-RCMP), Universiti Kuala Lumpur, Greentown, Ipoh 30450, Malaysia.

出版信息

J Med Microbiol. 2017 Oct;66(10):1379-1382. doi: 10.1099/jmm.0.000514. Epub 2017 Sep 13.

Abstract

BACKGROUND

Sustainable suppression of HIV replication forms the basis of anti-retroviral therapy (ART) medication. Thus, reliable quantification of HIV viral load has become an essential factor to monitor the effectiveness of the ART. Longer turnaround-time (TAT), batch testing and technical skills are major drawbacks of standard real-time PCR assays.

METHODS

The performance of the point-of-care Xpert HIV-1 viral load assay was evaluated against the Abbott RealTime PCR m2000rt system. A total of 96 plasma specimens ranging from 2.5 log10 copies ml to 4.99 log10 copies ml and proficiency testing panel specimens were used. Precision and accuracy were checked using the Pearson correlation co-efficient test and Bland-Altman analysis.

RESULTS

Compared to the Abbott RealTime PCR, the Xpert HIV-1 viral load assay showed a good correlation (Pearson r=0.81; P<0.0001) with a mean difference of 0.27 log10 copies ml (95 % CI, -0.41 to 0.96 log10 copies ml; sd, 0.35 log10 copies ml).

CONCLUSION

Reliable and ease of testing individual specimens could make the Xpert HIV-1 viral load assay an efficient alternative method for ART monitoring in clinical management of HIV disease in resource-limited settings. The rapid test results (less than 2 h) could help in making an immediate clinical decision, which further strengthens patient care.

摘要

背景

持续抑制HIV复制是抗逆转录病毒疗法(ART)药物治疗的基础。因此,可靠地定量HIV病毒载量已成为监测ART疗效的重要因素。较长的周转时间(TAT)、批量检测和技术技能是标准实时PCR检测的主要缺点。

方法

针对雅培实时PCR m2000rt系统评估即时检测的Xpert HIV-1病毒载量检测的性能。共使用了96份血浆标本,病毒载量范围为2.5 log10拷贝/毫升至4.99 log10拷贝/毫升,以及能力验证检测小组的标本。使用Pearson相关系数检验和Bland-Altman分析检查精密度和准确性。

结果

与雅培实时PCR相比,Xpert HIV-1病毒载量检测显示出良好的相关性(Pearson r = 0.81;P < 0.0001),平均差异为0.27 log10拷贝/毫升(95% CI,-0.41至0.96 log10拷贝/毫升;标准差,0.35 log10拷贝/毫升)。

结论

可靠且易于检测单个标本可使Xpert HIV-1病毒载量检测成为资源有限环境下HIV疾病临床管理中ART监测的有效替代方法。快速的检测结果(不到2小时)有助于做出即时临床决策,这进一步加强了患者护理。

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