The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field
The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field
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DOI：
10.1186/1472-6963-10-73
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发表时间：
2010-03-22
影响因子：
2.8
通讯作者：
Lurie, Mark N.
中科院分区：
文献类型：
--
作者：
Wolpaw, Benjamin J.;Mathews, Catherine;Lurie, Mark N.
背景：快速艾滋病毒抗体检测是低收入和中等收入国家的首选诊断工具。以前的证据表明，快速的艾滋病毒诊断测试在这一领域可能表现不佳，无法检测到大量感染。一项研究无意中发现，临床快速HIV检测过程未能检测到已确定的（高抗体滴度）感染病例，在前三周的观察过程中，估计灵敏度为68.7% （95% CI[41.3%-89.0%]）。这是一家公共服务诊所，在南非开普敦郊外一个贫困的城郊社区提供性传播感染诊断和治疗。方法：研究人员与当地卫生管理人员合作，调查测试成绩不佳的原因，并作出必要的纠正。该诊所改变了使用的快速检测品牌，后来又引入了质量改进措施。在诊所工作人员对真正的病人进行快速艾滋病毒检测时，对他们进行了观察。估计检测灵敏度的计算方法为：诊所检测到的HIV快速检测阳性个体的数量除以该数量加上在诊所快速检测阴性的患者中发现的PCR阳性、高反应性3（rd）代ELISA患者的数量。结果：在诊所改用快速艾滋病毒检测后的5个月内，估计灵敏度提高到93.5% (95% CI[86.5%-97.6%])，在此期间，在诊所进行检测的辅导员观察发现，对推荐的检测方案的依从性较差。实施了质量改进措施，在最后两个月的全面观察中，估计灵敏度上升到95.1% （95% CI[83.5%-99.4%]）。结论：现场糟糕的检测程序可能导致HIV快速检测灵敏度极低，因此在尚未实施严格质量控制措施的地方必须实施严格的质量控制措施。某些品牌的快速检测试剂盒在面对次优使用时可能比其他品牌的表现更好。
Background: The rapid HIV antibody test is the diagnostic tool of choice in low and middle-income countries. Previous evidence suggests that rapid HIV diagnostic tests may underperform in the field, failing to detect a substantial number of infections. A research study inadvertently discovered that a clinic rapid HIV testing process was failing to detect cases of established (high antibody titer) infection, exhibiting an estimated 68.7% sensitivity (95% CI [41.3%-89.0%]) over the course of the first three weeks of observation. The setting is a public service clinic that provides STI diagnosis and treatment in an impoverished, peri-urban community outside of Cape Town, South Africa.Methods: The researchers and local health administrators collaborated to investigate the cause of the poor test performance and make necessary corrections. The clinic changed the brand of rapid test being used and later introduced quality improvement measures. Observations were made of the clinic staff as they administered rapid HIV tests to real patients. Estimated testing sensitivity was calculated as the number of rapid HIV test positive individuals detected by the clinic divided by this number plus the number of PCR positive, highly reactive 3(rd) generation ELISA patients identified among those who were rapid test negative at the clinic.Results: In the period of five months after the clinic made the switch of rapid HIV tests, estimated sensitivity improved to 93.5% (95% CI [86.5%-97.6%]), during which time observations of counselors administering tests at the clinic found poor adherence to the recommended testing protocol. Quality improvement measures were implemented and estimated sensitivity rose to 95.1% (95% CI [83.5%-99.4%]) during the final two months of full observation.Conclusions: Poor testing procedure in the field can lead to exceedingly low levels of rapid HIV test sensitivity, making it imperative that stringent quality control measures are implemented where they do not already exist. Certain brands of rapid-testing kits may perform better than others when faced with sub-optimal use.