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Objective <p>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.</p> Results <p>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 (<i>r</i> = 0.97, <i>p</i> &lt; 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.</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月21日

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  • Keembe Siakantu,
  • David Chisompola,
  • Aaron Tembo Konzani

摘要

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.