Challenges and Pragmatic Solutions for Assessing the Reliability of HIV-1 Viral Load Monitoring in Resource-Constrained Settings.

IF 3.2 4区医学 Q3 VIROLOGY Intervirology Pub Date : 2024-01-01 Epub Date: 2023-11-26 DOI:10.1159/000535064

John Paul Demosthenes, Ben Chirag Ghale, Diviya Alex, Veena Vadhini Ramalingam, Gnanadurai John Fletcher, Priya Abraham, Rajesh Kannangai

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Abstract

Introduction: HIV-1 RNA detection is the most reliable method for monitoring treatment response among people living with HIV. Effective quality control measures that include internal quality control (IQC) are challenging in resource-constrained settings.

Methods: We ascertained the utility of the kit low positive control (LPC) as an effective IQC to monitor the reliability of the HIV-1 viral load assay. Variations in LPC values were measured for 390 different runs over 10 years (2011-2021) and compared to in-house IQC data using Levey-Jennings control chart.

Results: Overall, the Levey-Jennings analysis showed minimal variation (±0.5 log) for both the LPC and IQC data. The mean LPC value for first 20 runs (20 days) was 2.91. The mean LPC value for the 390 runs comprising 35 different lots was 3.01 ± 0.1 log.

Conclusion: Our decadal data reveal that Abbott RealTime HIV-1 assay (Abbott Molecular Inc., IL, USA) LPC exhibited no significant biological variation over 390 runs distributed over 10 years. Hence, assay LPC can supplant the IQC for monitoring assay trends as a stable and commutable material in resource-constrained settings.

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在资源受限环境下评估HIV-1病毒载量监测可靠性的挑战和实用的解决方案。

HIV-1 RNA检测是监测HIV感染者(PLHIV)治疗反应最可靠的方法。在资源受限的环境下，包括内部质量控制(IQC)在内的有效质量控制措施具有挑战性。方法:我们确定了低阳性对照(LPC)作为有效的内部质量控制(IQC)的效用，以监测HIV-1病毒载量测定的可靠性。在10年(2011-2021年)的390次不同运行中测量了LPC值的变化，并使用Levey-Jennings控制图对内部IQC数据进行了比较。结果:总体而言，Levey-Jennings分析显示LPC和IQC数据的变化最小(±0.5 log)。前20次(20天)的平均LPC值为2.91。由35个不同批次组成的390次试验的平均LPC值为3.01±0.1 log。结论:我们的十年数据显示，雅培实时HIV-1测定(雅培分子公司，IL，美国)LPC在10年内分布的390次试验中没有明显的生物学变化。因此，在资源有限的情况下，分析LPC可以取代IQC作为稳定和可交换的材料监测分析趋势。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Intervirology 医学-病毒学

CiteScore

5.40

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： ''Intervirology'' covers progress in both basic and clinical virus research, and aims to provide a forum for the various disciplines within virology. Issues publishing original papers alternate with thematic issues, focusing on clearly defined topics. This thematic concentration serves to make timely reviews, research reports and controversy easily accessible to both specialists in the field and those who want to keep track of the latest developments outside their own area of interest. In addition to original papers, regular issues publish short communications and letters to the editor to provide readers with a forum for the exchange of ideas and comments. The scope encompasses work on the molecular biology of human and animal viruses, including genome organization and regulation, and the structure and function of viral proteins. The pathogenesis, immunology, diagnosis, epidemiology, prophylaxis and therapy of viral diseases are considered.