Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities
Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities
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DOI：
10.1097/qad.0b013e328331f702
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发表时间：
2009-11-27
期刊：
影响因子：
3.8
通讯作者：
Crump, John A.
中科院分区：
文献类型：
--
作者：
Lofgren, Sarah M.;Morrissey, Anne B.;Crump, John A.
目的：评估基于干血斑点(DBS)的HIV-1 RNA服务在低收入国家偏远医疗机构中的技术和操作性能。设计：在坦桑尼亚现场条件下，将DBS RNA与传统的婴儿HIV和HIV RNA定量检测方法进行比较和操作评价。方法：制备DBS并在-80℃冰冻血浆，将DBS邮寄和血浆送至中心实验室，使用雅培M2000系统进行检测。用罗氏COBAS AmpliPrep/COBAS TaqMan系统对婴儿诊断数据库进行HIV-1 DNA检测。结果：在176例婴幼儿诊断中，以至少1000拷贝/ml为临界值，DBS与血浆RNA的敏感性和特异性分别为1.00和0.99，DBS RNA和DBS DNA的敏感性和特异性分别为0.97和1.00。在13 7名病毒载量监测者中，比较血浆和DBS RNA时，r值为0.9709；至少5 000拷贝/ml的r值为0.9675，低于5 000拷贝/ml的r值为0.7301。未检测到DBS RNA的血浆RNA值最高为2 084拷贝/ml。从采集样本到现场结果接收的中位(范围)时间为23(4-69)天。坦桑尼亚邮寄服务成功地在站点和中心实验室之间传输了所有DBS和结果。结论：在坦桑尼亚的计划条件下，DBS向远程医疗机构提供了与传统方法相当的HIV-1 RNA结果。DBS RNA检测是在偏远地区提供HIV-1 RNA服务的液体血浆的替代方案。(C)2009年Wolters Kluwer Health|Lippincott Williams&Wilkins
Objective: To assess technical and operational performance of a dried blood spot (DBS)-based HIV-1 RNA service for remote healthcare facilities in a low-income country.Design: A method comparison and operational evaluation of DBS RNA against conventional tests for early infant diagnosis of HIV and HIV RNA quantitation under field conditions in Tanzania.Methods: DBSs were prepared and plasma was frozen at -80 degrees C. DBSs were mailed and plasma couriered to a central laboratory for testing using the Abbott m2000 system. Infant diagnosis DBSs were also tested for HIV-1 DNA by ROCHE COBAS AmpliPrep/COBAS TaqMan System. Results of DBS RNA were compared with conventional tests; program performance was described.Results: Among 176 infant diagnosis participants, using a threshold of at least 1000 copies/ml, sensitivity and specificity of DBS versus plasma RNA were 1.00 and 0.99, and of DBS RNA versus DBS DNA were 0.97 and 1.00. Among 137 viral load monitoring participants, when plasma and DBS RNA were compared, r value was 0.9709; r value was 0.9675 for at least 5000 copies/ml but was 0.7301 for less than 5000 copies/ml. The highest plasma RNA value at which DBS RNA was not detected was 2084 copies/ml. Median (range) turnaround time from sample collection to result receipt at sites was 23 (4-69) days. The Tanzania mail service successfully transmitted all DBS and results between sites and the central laboratory.Conclusion: Under program conditions in Tanzania, DBS provided HIV-1 RNA results comparable to conventional methods to remote healthcare facilities. DBS RNA testing is an alternative to liquid plasma for HIV-1 RNA services in remote areas. (C) 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins