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在赞比亚索卢韦齐综合医院使用即时检测Xpert HIV-1系统评估HIV-1病毒载量检测的准确性。

Evaluating the accuracy of HIV-1 viral load testing using near point of care Xpert HIV-1 system at Solwezi general hospital, Zambia.

作者信息

Siakantu Keembe, Chisompola David, Konzani Aaron Tembo

机构信息

Pathology Laboratory Dept, Solwezi General Hospital, Solwezi, Zambia.

Pathology Laboratory Dept, Arthur Davison Children's Hospital, Ndola, Zambia.

出版信息

BMC Res Notes. 2025 Jul 21;18(1):313. doi: 10.1186/s13104-025-07387-w.

Abstract

OBJECTIVE

HIV-1 Viral Load Testing plays a crucial role in the management of HIV/AIDS patients by quantifying the presence of HIV-1 RNA in the blood, which directly relates to viral replication and disease progression. Monitoring viral load enables healthcare professionals to evaluate the effectiveness of Anti-Retroviral Therapy, adapt treatment strategies, and assess the overall health status of individuals with HIV. This was a cross-sectional study to evaluate analytical performance (accuracy, precision and linearity) of the near point of care Xpert HIV-1 viral load.

RESULTS

The analytical performance of the GeneXpert assay to the conventional Hologic Panther system was strong. Specifically, the GeneXpert demonstrated a sensitivity, specificity, and accuracy of 87.6%, 100%, and 98.5%, respectively, when compared to the Hologic Panther. A strong correlation between the two assays was evident (r = 0.97, p < 0.0001). Additionally, precision, as indicated by the coefficient of variation (CV), for high viral load was 1.38% for GeneXpert while for low viral load, it was 2.59%. In the linearity analysis, all data points remained within acceptable ranges, yielding correlation coefficients ≥ 0.99 for both assays.

CONCLUSION

The Xpert HIV-1 viral load assay demonstrates high efficacy in accurately identifying and quantifying HIV-1 viral loads, making it a valuable tool for HIV diagnosis and monitoring. This reliability makes it particularly suitable for critical populations requiring timely and accurate viral load monitoring.

摘要

目的

HIV-1病毒载量检测通过定量血液中HIV-1 RNA的存在,在HIV/AIDS患者的管理中发挥着关键作用,这直接关系到病毒复制和疾病进展。监测病毒载量使医疗保健专业人员能够评估抗逆转录病毒疗法的有效性、调整治疗策略,并评估HIV感染者的整体健康状况。这是一项横断面研究,旨在评估即时检测(POC)的Xpert HIV-1病毒载量的分析性能(准确性、精密度和线性)。

结果

GeneXpert检测法与传统的Hologic Panther系统相比,分析性能很强。具体而言,与Hologic Panther相比,GeneXpert的灵敏度、特异性和准确性分别为87.6%、100%和98.5%。两种检测方法之间存在明显的强相关性(r = 0.97,p < .0001)。此外,以变异系数(CV)表示的精密度方面,对于高病毒载量,GeneXpert为1.38%,对于低病毒载量,为2.59%。在线性分析中,所有数据点均保持在可接受范围内,两种检测方法的相关系数均≥0.99。

结论

Xpert HIV-1病毒载量检测法在准确识别和定量HIV-1病毒载量方面显示出高效能,使其成为HIV诊断和监测的宝贵工具。这种可靠性使其特别适用于需要及时准确进行病毒载量监测的关键人群。

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