常规快速 HIV 检测的失败：提高现场低灵敏度的案例研究。
The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field.
机构信息
Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa.
出版信息
BMC Health Serv Res. 2010 Mar 22;10:73. doi: 10.1186/1472-6963-10-73.
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 3rd 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.
背景
快速 HIV 抗体检测是中低收入国家的首选诊断工具。先前的证据表明，快速 HIV 诊断检测在实际应用中可能表现不佳，未能检测到大量感染病例。一项研究意外发现，一家诊所的快速 HIV 检测程序未能检测到已确诊（高抗体滴度）的感染病例，在最初三周的观察过程中，其敏感性估计为 68.7%（95%CI [41.3%-89.0%]）。该研究地点是南非开普敦郊区一个贫困地区的公共服务诊所，提供性传播感染诊断和治疗服务。
方法
研究人员和当地卫生管理人员合作调查检测性能不佳的原因，并进行必要的纠正。诊所更换了正在使用的快速检测品牌，后来还引入了质量改进措施。观察了诊所工作人员对实际患者进行快速 HIV 检测的情况。检测敏感性的估计值为诊所检测到的快速 HIV 检测阳性个体数量除以该数量与在诊所快速检测阴性但 PCR 阳性、高反应性第三代 ELISA 患者数量之和。
结果
在诊所更换快速 HIV 检测后的五个月期间，估计敏感性提高到 93.5%（95%CI [86.5%-97.6%]），在此期间，对在诊所进行检测的咨询师进行观察发现，他们未能严格遵守推荐的检测方案。实施了质量改进措施后，在全面观察的最后两个月期间，估计敏感性提高到 95.1%（95%CI [83.5%-99.4%]）。
结论
现场检测程序不佳可能导致快速 HIV 检测敏感性极低，因此，在尚未实施严格质量控制措施的地方，必须实施这些措施。在面临使用不理想的情况时，某些品牌的快速检测试剂盒的性能可能优于其他品牌。
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