Vitalant Research Institute, San Francisco, California, USA.
Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California, USA.
Microbiol Spectr. 2023 Feb 14;11(1):e0339822. doi: 10.1128/spectrum.03398-22. Epub 2023 Jan 17.
The HIV epidemic is still one of the world's most serious public health challenges, affecting about 38 million people worldwide, especially in sub-Saharan African and Southeast Asian countries. In recent years, tests have been developed to discriminate recent from long-term infection in HIV-infected populations, and these tools can help identify new outbreaks and networks of transmission and target prevention and treatment plans. New rapid tests for recent infection are being deployed in point-of-care settings; however, quality assurance programs need to be implemented to ensure consistency and reliability of the results. We have developed a dried tube specimen (DTS) stabilized with disaccharide trehalose as a quality control reagent for rapid recency testing that can be stored unrefrigerated prior to reconstitution at temperatures up to 37°C for up to 12 weeks. Analysis of 10 trehalose-stabilized DTSs showed that they maintained the same recency classification in all of the samples stored at 4°C and 37°C up to 12 weeks and at 56°C for 2 weeks, while the DTSs prepared without trehalose changed their classification from long-term to recent or recent to negative after storage at 37°C for 12 weeks. Development of DTS quality control reagents will facilitate proficiency and training programs, particularly in settings without cold chain capability in field environments. Implementation of stabilized dried tube specimens (DTSs) for quality control and training would facilitate HIV recency programs, especially in point-of-care settings without cold chain availability. This study shows that addition of the disaccharide trehalose to DTSs prior to drying the samples increased stability of the samples across a range of temperatures. This finding provides an affordable way to increase the availability of these key reagents for quality control in resource-constrained settings.
艾滋病毒疫情仍然是世界上最严重的公共卫生挑战之一，影响着全球约 3800 万人，特别是撒哈拉以南非洲和东南亚国家。近年来，已经开发出一些测试方法来区分艾滋病毒感染者中的近期和长期感染，这些工具可以帮助识别新的疫情爆发和传播网络，并针对预防和治疗计划进行目标定位。新的近期感染快速测试正在护理点环境中部署；然而，需要实施质量保证计划，以确保结果的一致性和可靠性。我们开发了一种用二糖海藻糖稳定的干燥管标本（DTS），作为快速近期检测的质量控制试剂，可以在未冷藏的情况下储存，在 37°C 下最多可在 12 周内再配制，无需冷藏。对 10 个海藻糖稳定的 DTS 的分析表明，在 4°C 和 37°C 下储存长达 12 周以及在 56°C 下储存 2 周的所有样本中，它们的近期分类保持不变，而在 37°C 下储存 12 周后，没有海藻糖的 DTS 从长期分类变为近期或近期分类变为阴性。DTS 质量控制试剂的开发将促进能力和培训计划，特别是在野外环境中没有冷链能力的地方。 实施稳定的干燥管标本（DTS）进行质量控制和培训将促进 HIV 近期项目，特别是在没有冷链的护理点环境中。本研究表明，在干燥样本之前向 DTS 添加二糖海藻糖可以提高样本在一系列温度下的稳定性。这一发现为在资源有限的环境中增加这些关键试剂的质量控制提供了一种经济实惠的方法。
