干管标本：在资源有限的环境中，制备 HIV 能力验证检测试剂盒和质量控制材料的简单且具有成本效益的方法。

Dried tube specimens: a simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings.

机构信息

International Laboratory Branch, Division of Global AIDS, Centers for Disease Control and Prevention, Atlanta, GA 30345, USA.

出版信息

J Virol Methods. 2010 Feb;163(2):295-300. doi: 10.1016/j.jviromet.2009.10.013. Epub 2009 Oct 28.

DOI:10.1016/j.jviromet.2009.10.013

PMID:19878697

Abstract

HIV testing has rapidly expanded worldwide, but proficiency testing (PT) programs to monitor and improve the quality of testing are often lacking in resource-limited settings (RLS). Traditional PT programs and quality control reagents use serum or plasma specimens requiring stringent conditions for storage and transportation. A novel, simple and easy to use approach, based on dried tube specimens (DTS), was developed that can help monitor the quality of HIV antibody testing in RLS. DTS were prepared by drying 20 microl of specimen overnight at room temperature. The addition of a green dye (0.1%) made the DTS pellets visible without affecting the test results. Before testing, the DTS were rehydrated with 200 microl of PBS-Tween buffer. A panel of 303 DTS samples (135 HIV positive and 168 HIV negative) was evaluated with two rapid tests. Sensitivity and specificity with the Determine HIV-1/2 test were 99.3% and 99.4%, respectively, and with OraQuick were 98.5% and 100%, respectively. Stability studies showed that HIV-specific antibodies in the DTS specimens were stable at 4 degrees C and 25 degrees C for 4 weeks, with only marginal decline at 37 degrees C and 45 degrees C over 4 weeks. The DTS-based PT program was piloted successfully in 24 testing sites in Kenya. Results demonstrate that the DTS is a simple to use, practical method to prepare and distribute PT panels and quality control specimens to monitor HIV testing practices in RLS.

摘要

HIV 检测在全球范围内迅速普及，但在资源有限的环境中（RLS），通常缺乏监测和提高检测质量的能力验证（PT）计划。传统的 PT 计划和质量控制试剂使用血清或血浆标本，这些标本在储存和运输方面需要严格的条件。本研究开发了一种新颖、简单易用的基于干管标本（DTS）的方法，可用于监测 RLS 中 HIV 抗体检测的质量。DTS 通过在室温下将 20 微升标本干燥过夜制成。添加 0.1%的绿色染料可使 DTS 颗粒可见，而不影响检测结果。在检测之前，DTS 用 200 微升 PBS-Tween 缓冲液复水。用两种快速检测方法对 303 个 DTS 样本（135 个 HIV 阳性和 168 个 HIV 阴性）进行了评估。与 Determine HIV-1/2 检测相比，DTS 的灵敏度和特异性分别为 99.3%和 99.4%，与 OraQuick 相比，DTS 的灵敏度和特异性分别为 98.5%和 100%。稳定性研究表明，DTS 标本中的 HIV 特异性抗体在 4°C 和 25°C 下稳定 4 周，在 37°C 和 45°C 下 4 周内略有下降。该基于 DTS 的 PT 计划在肯尼亚的 24 个检测点成功进行了试点。结果表明，DTS 是一种简单易用的方法，可用于制备和分发 PT 试剂盒和质量控制标本，以监测 RLS 中的 HIV 检测实践。