Nguyen Shon, Ramos Artur, Chang Joy, Li Bin, Shanmugam Vedapuri, Boeras Debrah, Nkengasong John N, Yang Chunfu, Ellenberger Dennis
Division of Global HIV/AIDS, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Division of HIV/AIDS Prevention, National Center for HIV, Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
J Clin Microbiol. 2015 Apr;53(4):1129-36. doi: 10.1128/JCM.02780-14. Epub 2015 Jan 21.
HIV-1 viral load (VL) levels are used for monitoring disease progression and antiretroviral therapy outcomes in HIV-infected patients. To assess the performance of laboratories conducting HIV-1 VL testing in resource-limited settings, the U.S. Centers for Disease Control and Prevention implemented a voluntary, free-of-charge, external quality assurance program using dried tube specimens (DTSs). Between 2010 and 2012, DTS proficiency testing (PT) panels consisting of 5 specimens were distributed at ambient temperature to participants. The results from the participants (n≥6) using the same assay were grouped, analyzed, and graded as acceptable within a group mean±3 standard deviations. Mean proficiency scores were calculated by dividing the combined PT scores by the number of testing cycles using a linear regression model. Between 2010 and 2012, the number of participants enrolled increased from 32 in 16 countries to 114 in 44 countries. A total of 78.2% of the participants reported results using 10 different VL assays. The rates of reporting of acceptable results by the participants were 96.6% for the Abbott assay, 96.3% for the Roche Cobas assay, 94.5% for the Roche Amplicor assay, 93.0% for the Biocentric assay, and 89.3% for the NucliSens assay. The overall mean proficiency scores improved over time (P=0.024). DTSs are a good alternative specimen type to plasma specimens for VL PT programs, as they do not require cold chain transportation and can be used on PCR-based assays. Our data suggest that the CDC HIV-1 VL PT program using DTSs positively impacts the testing performance of the participants, which might translate into better and more accurate VL testing services for patients.
HIV-1病毒载量（VL）水平用于监测HIV感染患者的疾病进展和抗逆转录病毒治疗效果。为评估在资源有限环境中开展HIV-1 VL检测的实验室的性能，美国疾病控制与预防中心实施了一项使用干管标本（DTS）的自愿、免费外部质量保证计划。2010年至2012年期间，由5个标本组成的DTS能力验证（PT）板在常温下分发给参与者。使用相同检测方法的参与者（n≥6）的结果进行分组、分析，并在组均值±3个标准差范围内判定为可接受。使用线性回归模型，通过将PT综合得分除以检测周期数来计算平均能力验证得分。2010年至2012年期间，参与的国家数量从16个增加到44个，参与者人数从32人增加到114人。共有78.2%的参与者使用10种不同的VL检测方法报告结果。参与者报告可接受结果的比例，雅培检测法为96.6%，罗氏Cobas检测法为96.3%，罗氏Amplicor检测法为94.5%，博生吉检测法为93.0%，NucliSens检测法为89.3%。总体平均能力验证得分随时间有所提高（P = 0.024）。对于VL PT计划，DTS是血浆标本的良好替代标本类型，因为它们不需要冷链运输，可用于基于PCR的检测。我们的数据表明，美国疾病控制与预防中心使用DTS的HIV-1 VL PT计划对参与者的检测性能产生了积极影响，这可能会为患者带来更好、更准确的VL检测服务。
