Abstract：
BACKGROUND: In Equatorial Guinea, only 54 % of people living with HIV know their HIV status. There are no confirmatory or molecular diagnostic techniques for early diagnosis or monitoring of infection in the country. Rapid diagnostic tests can induce false-positive diagnoses if used as a confirmatory technique. Our study aimed to identify the challenges of early HIV diagnosis in Equatorial Guinea by analyzing the rate of false positive diagnoses, diagnostic and therapeutic delays, and treatment failures among those on antiretroviral therapy.
METHODS: From 2019-2022, dried blood from 341 children, adolescents and adults diagnosed in Equatorial Guinea as HIV-positive by rapid diagnostic testing, and from 54 HIV-exposed infants were collected in Bata and sent to Madrid to confirm HIV-infection by molecular (Xpert HIV-1Qual, Cepheid) and/or serological confirmatory assays (Geenius-HIV-1/2, BioRad). HIV diagnostic delay (CD4 <350cells/mm3), advanced disease at diagnosis (CD4 <200cells/mm3) and antiretroviral treatment delay and failure (viraemia >1,000RNA-HIV-1-copies/ml) were also studied after viral quantification (XpertVL HIV-1, Cepheid).
RESULTS: False-positive diagnoses were identified in 5 % of analysed samples. HIV infection was confirmed in 90.5 % of previously diagnosed patients in Equatorial Guinea and 3.7 % of HIV-exposed children undiagnosed in the field. Two-thirds of each new HIV patient had delayed diagnosis, and one-third had advanced disease. Treatment delay occurred in 28.3 % of patients, being around four times more likely in adolescents/adults than children. More than half (56 %) of 232 treated patients presented treatment failure, being significantly higher in children/adolescents than in adults (82.9 %/90 % vs. 45.6 %, p < 0.001).
CONCLUSIONS: We identified some challenges of early HIV diagnosis in Equatorial Guinea, revealing a high rate of false positive diagnoses, diagnostic/treatment delays, and treatment failures that need to be addressed. The implementation of more accurate rapid diagnostic techniques and confirmatory tests, along with improving access to care, treatment, awareness, and screening, would contribute to controlling the spread of HIV in the country.
METHODS: From 2019-2022, dried blood from 341 children, adolescents and adults diagnosed in Equatorial Guinea as HIV-positive by rapid diagnostic testing, and from 54 HIV-exposed infants were collected in Bata and sent to Madrid to confirm HIV-infection by molecular (Xpert HIV-1Qual, Cepheid) and/or serological confirmatory assays (Geenius-HIV-1/2, BioRad). HIV diagnostic delay (CD4 <350cells/mm3), advanced disease at diagnosis (CD4 <200cells/mm3) and antiretroviral treatment delay and failure (viraemia >1,000RNA-HIV-1-copies/ml) were also studied after viral quantification (XpertVL HIV-1, Cepheid).
RESULTS: False-positive diagnoses were identified in 5 % of analysed samples. HIV infection was confirmed in 90.5 % of previously diagnosed patients in Equatorial Guinea and 3.7 % of HIV-exposed children undiagnosed in the field. Two-thirds of each new HIV patient had delayed diagnosis, and one-third had advanced disease. Treatment delay occurred in 28.3 % of patients, being around four times more likely in adolescents/adults than children. More than half (56 %) of 232 treated patients presented treatment failure, being significantly higher in children/adolescents than in adults (82.9 %/90 % vs. 45.6 %, p < 0.001).
CONCLUSIONS: We identified some challenges of early HIV diagnosis in Equatorial Guinea, revealing a high rate of false positive diagnoses, diagnostic/treatment delays, and treatment failures that need to be addressed. The implementation of more accurate rapid diagnostic techniques and confirmatory tests, along with improving access to care, treatment, awareness, and screening, would contribute to controlling the spread of HIV in the country.
摘要：
背景：在赤道几内亚，只有54％的艾滋病毒感染者知道自己的艾滋病毒状况。该国没有用于早期诊断或监测感染的确认或分子诊断技术。如果将快速诊断测试用作确认技术，则可以引起假阳性诊断。我们的研究旨在通过分析假阳性诊断率来确定赤道几内亚早期HIV诊断的挑战，诊断和治疗延迟，以及接受抗逆转录病毒治疗的患者的治疗失败。
方法：从2019-2022年，341名儿童的干血，赤道几内亚的青少年和成年人通过快速诊断检测被诊断为HIV阳性，并从Bata收集了54名暴露于艾滋病毒的婴儿，并将其送往马德里，以确认分子感染艾滋病毒（XpertHIV-1Qual，造父变菌）和/或血清学确认测定（Geenius-HIV-1/2，BioRad）。HIV诊断延迟（CD4<350个细胞/mm3），在病毒定量(XpertVLHIV-1,Cepheid)后,还研究了诊断时的晚期疾病(CD4<200个细胞/mm3)和抗逆转录病毒治疗延迟和失败(病毒血症>1,000RNA-HIV-1拷贝/ml)。
结果：在5%的分析样本中发现了假阳性诊断。在赤道几内亚，90.5%的先前诊断的患者和3.7%的未在实地诊断的艾滋病毒暴露儿童中确认了艾滋病毒感染。每个新的HIV患者中有三分之二的诊断延迟，三分之一的人患有晚期疾病。28.3%的患者出现治疗延迟，青少年/成人的可能性是儿童的四倍左右。232名接受治疗的患者中有一半以上（56%）出现治疗失败，儿童/青少年明显高于成人(82.9%/90%vs.45.6%,p<0.001)。
结论：我们确定了赤道几内亚早期HIV诊断的一些挑战，揭示出假阳性诊断率很高，诊断/治疗延迟，以及需要解决的治疗失败。实施更准确的快速诊断技术和验证性测试，除了改善获得护理的机会，治疗,意识,和筛选，将有助于控制艾滋病毒在该国的传播。
方法：从2019-2022年，341名儿童的干血，赤道几内亚的青少年和成年人通过快速诊断检测被诊断为HIV阳性，并从Bata收集了54名暴露于艾滋病毒的婴儿，并将其送往马德里，以确认分子感染艾滋病毒（XpertHIV-1Qual，造父变菌）和/或血清学确认测定（Geenius-HIV-1/2，BioRad）。HIV诊断延迟（CD4<350个细胞/mm3），在病毒定量(XpertVLHIV-1,Cepheid)后,还研究了诊断时的晚期疾病(CD4<200个细胞/mm3)和抗逆转录病毒治疗延迟和失败(病毒血症>1,000RNA-HIV-1拷贝/ml)。
结果：在5%的分析样本中发现了假阳性诊断。在赤道几内亚，90.5%的先前诊断的患者和3.7%的未在实地诊断的艾滋病毒暴露儿童中确认了艾滋病毒感染。每个新的HIV患者中有三分之二的诊断延迟，三分之一的人患有晚期疾病。28.3%的患者出现治疗延迟，青少年/成人的可能性是儿童的四倍左右。232名接受治疗的患者中有一半以上（56%）出现治疗失败，儿童/青少年明显高于成人(82.9%/90%vs.45.6%,p<0.001)。
结论：我们确定了赤道几内亚早期HIV诊断的一些挑战，揭示出假阳性诊断率很高，诊断/治疗延迟，以及需要解决的治疗失败。实施更准确的快速诊断技术和验证性测试，除了改善获得护理的机会，治疗,意识,和筛选，将有助于控制艾滋病毒在该国的传播。
