HIV misdiagnosis in sub-Saharan Africa: performance of diagnostic algorithms at six testing sites.
HIV misdiagnosis in sub-Saharan Africa: performance of diagnostic algorithms at six testing sites.
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DOI：
10.7448/ias.20.1.21419
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发表时间：
2017-07-03
影响因子：
6
通讯作者：
Page AL
中科院分区：
文献类型：
--
作者：
Kosack CS;Shanks L;Beelaert G;Benson T;Savane A;Ng'ang'a A;Andre B;Zahinda JB;Fransen K;Page AL
我们评估了撒哈拉以南非洲5个国家的6个艾滋病检测方案的诊断准确性。方法：在这项前瞻性多地点诊断评估研究（几内亚科纳克里、乌干达基特古姆、乌干达阿鲁阿、肯尼亚霍马湾、喀麦隆杜拉和刚果民主共和国巴拉卡）中，收集了来自客户（大于5岁）的艾滋病毒检测样本，并与来自比利时热带医学研究所艾滋病参考实验室的最先进算法进行了比较。参考算法包括酶联免疫吸附测定、线免疫测定、单抗原-酶免疫测定和DNA聚合酶链反应试验。结果：2011年8月至2015年1月，在6个艾滋病毒咨询和检测站点进行了14000多名客户的艾滋病毒检测。其中，2786人（中位年龄：30岁，38.1%为男性）被纳入研究。检测算法的敏感性从阿鲁阿的89.5%到杜阿拉和科纳克里的100%不等，特异性从杜拉的98.3%到科纳克里的100%不等。总体而言，24例（0.9%）患者被误诊，每个站点多达8例（1.7%），其中16例假阳性，8例假阴性。6份假阴性标本在同一样本上用现场算法重新检测，结果为阳性。相反，13例假阳性标本重新检测，其中8例仍为现场算法假阳性。结论：几个站点的算法性能未能达到世界卫生组织设定的预期和阈值，结果错误率高得令人无法接受。除了仔细选择快速诊断测试和验证算法外，严格遵守正确的程序可以减少错误结果的风险。同时，为了在初始检测中识别假阳性诊断，患者应在开始抗逆转录病毒治疗后重新检测。
Introduction: We evaluated the diagnostic accuracy of HIV testing algorithms at six programmes in five sub-Saharan African countries. Methods: In this prospective multisite diagnostic evaluation study (Conakry, Guinea; Kitgum, Uganda; Arua, Uganda; Homa Bay, Kenya; Doula, Cameroun and Baraka, Democratic Republic of Congo), samples from clients (greater than equal to five years of age) testing for HIV were collected and compared to a state-of-the-art algorithm from the AIDS reference laboratory at the Institute of Tropical Medicine, Belgium. The reference algorithm consisted of an enzyme-linked immuno-sorbent assay, a line-immunoassay, a single antigen-enzyme immunoassay and a DNA polymerase chain reaction test. Results: Between August 2011 and January 2015, over 14,000 clients were tested for HIV at 6 HIV counselling and testing sites. Of those, 2786 (median age: 30; 38.1% males) were included in the study. Sensitivity of the testing algorithms ranged from 89.5% in Arua to 100% in Douala and Conakry, while specificity ranged from 98.3% in Doula to 100% in Conakry. Overall, 24 (0.9%) clients, and as many as 8 per site (1.7%), were misdiagnosed, with 16 false-positive and 8 false-negative results. Six false-negative specimens were retested with the on-site algorithm on the same sample and were found to be positive. Conversely, 13 false-positive specimens were retested: 8 remained false-positive with the on-site algorithm. Conclusions: The performance of algorithms at several sites failed to meet expectations and thresholds set by the World Health Organization, with unacceptably high rates of false results. Alongside the careful selection of rapid diagnostic tests and the validation of algorithms, strictly observing correct procedures can reduce the risk of false results. In the meantime, to identify false-positive diagnoses at initial testing, patients should be retested upon initiating antiretroviral therapy.