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在泰国曼谷大都市的男男性行为者移动诊所环境中,验证和评估用于抗 HIV 检测算法。

The validation and evaluation of anti-HIV testing algorithm used in mobile clinic setting for men who have sex with men in metropolitan Bangkok, Thailand.

机构信息

Anonymous Clinic Laboratory, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.

Faculty of Medical Technology, Prince of Songkla University, Songkhla, Thailand.

出版信息

Asian Pac J Allergy Immunol. 2018 Mar;36(1):42-50. doi: 10.12932/AP0833.

DOI:10.12932/AP0833
PMID:28364412
Abstract

BACKGROUND

Same-day anti-HIV testing algorithm is recommended by Thai National Guidelines. We compared performance characteristics of algorithms used in a mobile clinic and a facility-based clinic for men who have sex with men (MSM) in Bangkok.

METHODS

Mobile clinic samples collected from 4 saunas and 2 spa venues were tested by Alere DetermineTM HIV 1/2, followed by DoubleCheck GoldTM Ultra HIV 1/2 and SD Bioline HIV 1/2 3.0. All samples were re-tested at the Thai Red Cross Anonymous Clinic (TRCAC) by Architect HIV Ag/Ab or Elecsys HIV combi PT, followed by Alere DetermineTM HIV 1/2 and Serodia HIV 1/2. Non-reactive samples were tested by Aptima nucleic acid amplification test (NAAT) and reactive/inconclusive samples were tested by less-sensitive immunoassays (IA) and HIV-1 RNA to detect acute HIV infection (positive NAAT or non-reactive IA/positive HIV-1 RNA).

RESULTS

Of 233 MSM, 36 (15.5%) had HIV infection diagnosed using mobile clinic algorithm. Two additional acute HIV cases (1 positive NAAT and 1 reactive Architect with detectable HIV-1 RNA) were diagnosed using TRCAC algorithm. The mobile clinic algorithm had a sensitivity of 94.9% (95% CI: 82.7, 99.4) and a specificity of 100% (95% CI: 98.1, 100).

CONCLUSION

Use of whole blood on rapid test kits demonstrated satisfactory performance and allowed same-day HIV test result through a mobile clinic model. For populations with high HIV incidence, careful history taking to define the window period is crucial and repeat testing must be encouraged if the testing algorithm does not include 4th generation anti-HIV assay or NAAT.

摘要

背景

泰国国家指南推荐同日抗 HIV 检测算法。我们比较了曼谷男男性行为者(MSM)流动诊所和医疗机构诊所使用的算法的性能特征。

方法

从 4 个桑拿浴室和 2 个水疗场所采集流动诊所样本,用 Alere DetermineTM HIV 1/2 进行检测,然后用 DoubleCheck GoldTM Ultra HIV 1/2 和 SD Bioline HIV 1/2 3.0 进行复测。所有样本均在泰国红十字会匿名诊所(TRCAC)用 Architect HIV Ag/Ab 或 Elecsys HIV combi PT 进行重测,然后用 Alere DetermineTM HIV 1/2 和 Serodia HIV 1/2 进行复测。非反应性样本用 Aptima 核酸扩增试验(NAAT)进行检测,反应性/不确定样本用敏感性较低的免疫测定法(IA)和 HIV-1 RNA 进行检测,以检测急性 HIV 感染(阳性 NAAT 或非反应性 IA/阳性 HIV-1 RNA)。

结果

在 233 名 MSM 中,有 36 人(15.5%)使用移动诊所算法诊断出 HIV 感染。另外 2 例急性 HIV 病例(1 例阳性 NAAT 和 1 例反应性 Architect 且可检测到 HIV-1 RNA)使用 TRCAC 算法诊断。移动诊所算法的敏感性为 94.9%(95%CI:82.7,99.4),特异性为 100%(95%CI:98.1,100)。

结论

使用快速检测试剂盒的全血检测结果令人满意,通过移动诊所模型可以当天获得 HIV 检测结果。对于 HIV 发病率高的人群,仔细询问窗口期病史至关重要,如果检测算法不包括第四代抗 HIV 检测或 NAAT,则必须鼓励重复检测。

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